News regarding Oslo Cancer Cluster

We are hiring an EU Advisor

EU Advisor

We are currently looking for an EU advisor with skills and experience in writing EU funding proposals. This is a fixed term contract with duration to the end of 2018. If successful, this can become a long-term contract after 2018. We are also open to discuss a part-time employment. The EU advisor will report directly to the General Manager of OCC.

Key tasks:

  • Increase awareness of the H2020 funding opportunities and benefits among the cluster members incl. start-ups, SMEs and academic investigators
  • Actively support the cluster members with identifying relevant and appropriate H2020 funding schemes and call topics in 1:1 consulting meetings
  • Assist companies in development of project proposals in H2020 funding instruments
  • Pro-actively use OCC`s strong international network to identify new partners and suitable consortia for cluster members
  • Co-ordinate with other (national or Nordic) funding schemes and innovation agencies for achieving larger synergies and ensuring maximum impact
  • Organization and preparation of events and workshops for stakeholder information, education etc. addressing the needs of the cluster members
  • Development of project proposals to attract funding for OCC and OCC Incubator activities

Key qualifications:

  • Relevant scientific education, oncology background advantageous
  • 3 to 5-year experience in EU project applications and potentially project management
  • Innovation management experience and understanding of the different stakeholders in EU projects (start-ups, SMEs, academic partners, global companies)
  • Strong analytic capabilities and understanding of biomedical R&D, innovation challenges and business models
  • Self-driven, result oriented and disciplined
  • Fluent in written and spoken English

The EU advisor will be part of the Oslo Cancer Cluster team. OCC can offer competitive benefits, a positive working environment and colleagues with a strong drive and passion in the field of expertise. If you have any questions regarding this position, please contact Kelly Scientific and recruitment advisor, Janne Stang, cellphone: + 47 400 37 302. Kelly Scientific is a recruitment agency working with industry related positions within the Life Science sector.

Three new members in Oslo Cancer Cluster

IRW Consulting, Eisai and Personalis, Inc. are all new members of the Oslo Cancer Cluster. Please read more about them below.

 

IRW Consulting AB

IRW is a Nordic Contract Research Organization (CRO) with more than 15 years of experience in conducting clinical trials, Non-Interventional Studies (NIS) and medical device studies. IRW has built an extensive network throughout all Nordic countries, as well as the rest of Europe and the US. Depending on the customer’s requirements, our staff is either outsourced or works with in-house projects. We cover all the stages of clinical development, from phase I to phase IV, including pediatric and non-interventional studies and all classes of medical device investigations.

With regional offices in Denmark, Finland, Norway and Sweden, IRW has experienced locally-based staff providing an optimum combination of local knowledge and expertise to assist you conduct your clinical trial as per country specific guidelines. Local presence not just ensures adherence to local requirements for submissions to the Ethic Committees and Regulatory Authorities but also the knowledge of local language facilitates the communication with all local parties involved in the project thereby avoiding possible misunderstandings and reducing approval process timelines.

Working with the full range of companies, from small start-ups to multi-national pharmaceutical corporations, we have learned how to tailor our services to the specific needs of our customers.  Our involvement in clinical trials covers both Europe and the US, always following the appropriate regulations wherever we work, either according to external party’s SOPs or our own.
Home page IRW Consulting AB

 

Personalis, Inc.
Personalis, Inc., was founded in February 2011 out of Stanford University with the mission to provide precision, high accuracy genomic sequencing and analysis to enable precision medicine in the areas of cancer, immuno-oncology, and inherited disease.

Personalis provides researchers and clinicians with highly accurate, comprehensive, and validated DNA and RNA sequencing and interpretation of human genomic data for cancer research, clinical trials, and diagnostics. Our ACE (Accuracy and Content Enhanced) technology goes beyond standard sequencing approaches, substantially increasing medically relevant coverage and accuracy.

Personalis builds on this enhanced sequencing foundation with innovative algorithms and proprietary databases for alignment, variant calling, annotation, and analysis. Through this comprehensive approach, we provide genomic data and interpretation of the highest accuracy. Our CLIA-licensed and CAP-accredited laboratory, in combination with our validated, high accuracy ACE NGS platforms enable seamless transition from discovery to commercialization for our partners.

Home page Personalis, Inc.

 

Eisai

Eisai is a global pharmaceutical company addressing unmet medical needs, and Eisai is committed to make contributions to better healthcare for patients and their families around the world through its business activities.

Eisai has identified neurology and oncology as important areas where there are many diseases for which treatments are still not well established. Concentrating our R&D resources in these areas, Eisai is striving to discover new highly effective treatments especially for neurology and oncology.

Eisai carries out drug discovery research, drug development research and clinical research throughout the world. Eisai pursues innovative new drug discovery by promoting the exchange of various knowledge and ideas from around the world.

Main activities within oncology are within breast cancer and liposarcoma, where Halaven (eribulin) a cytotstatic agent, has shown survival benefit in both tumour types. Halaven is a novel anticancer agent discovered and developed by Eisai, has been launched in Japan, the United States, Europe and Asia.

Lenvima (lenvatinib), a multi targeted tyrosine kinase inhibitor (TKI), discovered and developed by Eisai, received orphan drug status and approval for radio-iodine refractory Differentiated Thyroid Cancer. Kisplyx (lenvatinib) was recently approved by EMA and FDA for use in advanced renal cell carcinoma. We are also involved in research in several other tumours.

Eisai AB is the Nordic affiliate and the Nordic office is in Stockholm.

 

 

 

 

 

Kronikk i Aftenposten: De nordiske landene kan gjøre noe resten av verden drømmer om

De nordiske landene bør samarbeide mer for å utvikle bedre kreftbehandlinger. Sammen kan Norden bli et globalt forsknings- og testsenter for nye kreftbehandlinger og -medisiner. Det kan gi store gevinster for kreftpasienter i hele verden. Denne kronikken sto på trykk i Aftenposten torsdag 9. mars.

Ketil Widerberg, daglig leder i Oslo Cancer Cluster, skrev kronikken samme uke som The Economist, Forskningsrådet og Oslo Cancer Cluster arrangerte den nordiske konferansen War on Cancer Nordics i Oslo. De nordiske landene ønsker å lede an i kampen mot kreft. Nå er det på tide at infrastrukturer og lovverk legges til rette for det.


Norden kan vise vei i kampen mot kreft. For vi har noe de andre – selv ikke USA – har


Design, TV-serier og nå: kreft
Nordisk design er verdenskjent, og nordisk film har gjennom TV-serier som Broen etablert en ny sjanger i underholdningsindustrien. På 1990-tallet endret Nokia og Ericsson hvordan vi brukte mobiltelefonen. Slike fremskritt setter Norden på det internasjonale kartet og skaper arbeidsplasser. Nå er tiden inne for liknende fremskritt i kampen mot kreft. Vi har gode forutsetninger, men er vi vårt ansvar bevisst?

Vi har fremragende kreftforskning, for eksempel innen immunterapi for kreft, fotodynamisk teknologi og radioaktive legemidler (radiofarmaka). På disse områdene gjør både nordiske forskere og bioteknologifirmaer det godt internasjonalt. Hver for seg er de nordiske landene små, men samlet har de over 26 millioner innbyggere, og er et interessant marked for forskning, bioteknologi- og legemiddelselskaper.


Norden har unike fortrinn
Norden har flere forutsetninger for å lykkes. Først og fremst har alle nordiske borgere et unikt personnummer. Dette mangler faktisk i mange andre land, som USA. Personnummer har gjort det mulig for nordiske myndigheter å samle unike helsedata. I over 60 år har de nordiske landene samlet helse- og kreftdata i biobanker og registre og bygd verdensledende helsesystemer. Den nordiske befolkningen har dessuten et stort digitalt liv, og samfunnet har generell tillit til forskning.

De nordiske landene kan bruke disse felles fortrinnene til å gjøre noe resten av verden drømmer om: bruke offentlige helsedata for å se hvilken lovende medisin som virker på hver enkelt pasient. Slik kan legemiddelet godkjennes og tas i bruk før de tradisjonelle tidkrevende og kostbare delene av klinisk utprøving blir satt i gang. Tiden det tar fra et kreftlegemiddel blir patentert til det blir godkjent til bruk vil bli kortere, og pasienten vil kunne få behandlingen flere år tidligere. Samfunnet vil kunne spare millioner. Norden bør være seg sitt ansvar bevisst og gå i bresjen for raskere utvikling av ny kreftbehandling. Vi har ikke råd til å vente.


Ny viten gir bedre behandling
Kreft er en av vår tids store samfunnsutfordringer. Hvert år dør 8 millioner mennesker av kreft i verden og 14 millioner av oss får en kreftdiagnose. Det er mange, og antallet vil øke. Ifølge Verdens helseorganisasjon vil det øke med hele 70 prosent de neste 20 årene.

Heldigvis øker også forståelsen av hvor komplekse sykdommene som vi kaller kreft er. Vi vet at det finnes over 200 kreftsykdommer, og vi vet at kreft påvirkes blant annet av genetiske faktorer. I tillegg har vi nå forstått at immunsystemet spiller en viktige rolle i utviklingen av ulike kreftsykdommer og at vi kan påvirke immunsystemet til å spille på lag med kroppen mot kreften. Økt kunnskap om hva kreft egentlig er gir oss bedre forutsetninger for å vinne kampen mot kreft. Men med ny viten følger også en ny dynamikk for hvordan behandling skal utvikles, kategoriseres og tilbys pasienter.


Tid for politisk vilje
Digitalisering av kreftforskning gir rask fremgang i mange land. Store globale teknologifirmaer som Microsoft, IBM og Google satser nå på helse, og spesifikt kreft. Med kunstig intelligens kan kreftforskere simulere, teste hypoteser og samle og korrelere data som ikke var mulig for kun få år siden. Norden har unike helsedatabaser, og vi kan bygge opp kompetanse sammen med globale selskaper på samme måte som Norge bygde opp oljeindustrien på 1970-tallet. Da inviterte Norge inn store internasjonale selskaper som utviklet oljeindustrien under statlig styring. Dette krevde samarbeid og tilrettelegging fra det offentlige.

En satsing på et nordisk kreftsamarbeid krever også offentlig tilrettelegging. Myndighetene og offentlige instanser må åpne for at forskere kan få bruke helsedataene vi allerede har. I Norden har vi strukturen som gjør det mulig å nå raskere fram med ny forskning. Vi kan hjelpe pasienter ved å godkjenne og ta i bruk legemidler før de tradisjonelle tidkrevende og dyre siste kliniske studiene settes i gang. Både USA og EU har forsøkt, men med begrenset hell, blant annet fordi de mangler personnummer og har fragmenterte helsesystemer. Der har de politisk vilje, men mangler strukturene.


Et globalt testsenter
Nordiske helsevesen samler inn stadig mer data fra befolkningen. Nå kan slike helsedata brukes til å utvikle medisiner raskere. Det vil stille nye krav til rapportering, sikkerhet og formål med bruk av helsedata. Det vil kreve en åpen og innovativ holdning både fra offentlige og private aktører. Dette er ikke risikofritt, men gevinsten for samfunnet og for den enkelte pasient som overlever takket være raskere og bedre behandling, vil være betydelig.

Norden har en unik mulighet til å være et globalt testsenter for utvikling av nye legemidler som utnytter den offentlige digitale infrastrukturen. Google endret hvordan vi bruker internettet. Vi gikk fra AltaVista til Google, og så oss aldri tilbake. Norden har alle forutsetninger for å lede an i digitaliseringen innen helse. Det kan være med på å endre livet til de 14 millionene nye menneskene som får kreft hvert år.

Ketil Widerberg, daglig leder i Oslo Cancer Cluster

Targovax to present at upcoming conferences

Oslo, Norway, 6 March 2017: Targovax ASA (“Targovax” or “the Company”; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target, primarily, treatment-resistant solid tumors, announces that members of its senior management will present at the following life sciences and investor conferences:

 

10th European Life Science CEO Forum (hosted by Sachs Associates)
Date: 7 March 2017
Venue: Hilton Zurich Airport Hotel, Zurich, Switzerland

Panel discussion time: 11:10 CET – Advances in Immuno-Oncology Therapeutics Panel

– Magnus Jäderberg (CMO)

Presentation time: 12:25 CET

– Øystein Soug (CEO)

 

Redeye – Fight Cancer Seminar
Date: 10 March 2017
Venue: Redeye, Stockholm, Sweden

Presentation time: 10:50 CET

Participants: Øystein Soug (CEO)

 

11th Annual BIO-Equity Spring 2017 Conference
Date: 20-22 March 2017
Venue: CCIB Convention Centre in Barcelona, Spain

Participants: Øystein Soug (CEO) and Peter Skorpil (VP Business Development)

 

The presentations will be available to download at www.targovax.com following these events.

 

For further information, please contact:

Renate Birkeli, Investor Relations

Phone: +47 922 61 624

Email: renate.birkeli@targovax.com

 

Media and IR enquires:

Jan Petter Stiff – Crux Advisers (Norway)

Phone: +47 995 13 891

Email: stiff@crux.no

 

Julia Phillips/Simon Conway – FTI Consulting (International)

Phone: +44 20 3727 1000

Email: Targovax@fticonsulting.com

 

About Targovax

Arming the patient’s immune system to fight cancer

Targovax is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

The Company’s development pipeline is based on two novel proprietary platforms:

The first platform, ONCOS, uses oncolytic viruses, an emerging class of biological therapy. ONCOS exclusively uses an adenovirus that has been engineered to be a tumor-targeted immune activator. The platform has the potential to generate therapies with superior efficacy and safety compared to the first approved oncolytic virus therapy, Imlygic®, launched by Amgen. We continue to expect key proof of concept data for this platform in 2017 from a clinical study of lead program ONCOS-102 in patients with refractory malignant melanoma.

The second platform, TG-Peptides (TGP), solely targets tumors that express mutated forms of the RAS protein. Mutations to this protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations.  The TGP platform’s therapeutic potential stems from its ability to enable a patient’s immune system to identify and then destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TGP platform from a clinical study of TG01 in resected pancreatic cancer patients showed encouraging overall survival and will determine plans for the future clinical development of this platform.

Targovax’s development pipeline has three novel therapeutic candidates in clinical development covering six indications. Already promising safety and tolerability data and early signs of clinical response have been demonstrated.

Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost-effective manner. We have a number in early stages of development in addition to the three outlined above.

In July, 2016 the Company listed its shares on Oslo Axess.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

– Join our online communities

Oslo Cancer Cluster has a new Head of Communications. She wants to help you reach out.

 

– One of the benefits of being a part of this cluster, is that you have me to help you out with communications, says Wenche Gerhardsen.

She is the new Head of Communications at Oslo Cancer Cluster. Wenche has a background as a journalist and a communications advisor within research and development. She worked as a senior advisor at The Norwegian Defence Research Establishment (FFI) before she started here in February 2017.

– Good communications is a tool we can use to better collaborations. We wish to help cluster members collaborate better – both with other members and with companies and academia outside the cluster.

 

Do you know our channels?
We have many communications channels that are wide open to members and others interested in our work. Check out our:

– Are you not part of our online community yet? Join in! I would love to see more active members in there.

You can contact Wenche in all the social media channels listed above and also on good old fashioned e-mail: wg@oslocancercluster.no

Former Head of Communications, Elisabeth Kirkeng Andersen, is now working as a consultant for the Oslo Cancer Cluster on communication through her own company. Andersen is also working as a communication consultant for Inven2, as well as serving as communication manager for the Radium Hospital Research Foundation.

 

 

Podcast on cancer research and development

Oslo Cancer Cluster member Radium Hospital Research Foundation, Radforsk, has launched their own podcast. The podcast is named Radium, and is about cancer research and development of new cancer treatments, as well as updates on Radforsk´s portfolio companies.

Radium has so far made nine episodes, and the ambition of Jónas Einarsson, CEO Radforsk and Elisabeth Kirkeng Andersen, communication manager in Radforsk, is to make one new episode a week. The podcasts are in Norwegian, if they do not interview people from abroad, as they did in the Cancer Crosslinks special.

Einarsson and Andersen is usually joined by guests in the studio, and so far they have had guests from Oslo Cancer Cluster members; PCI Biotech, Ultimovacs, Targovax, Vaccibody, Oncoinvent, as well as Roy Larsen and Øyvind Bruland, talking about Algeta, Nordic Nanovector and Oncoinvent.

Upcoming epiosodes will include guests such as Professor Håvard Danielsen from Institute for Cancer Genetics and Informatics, Anne Lise Ryel, General Secretary in the Norwegian Cancer Society and CEO, Kjetil Hestdal in Photocure.

Here you may find all podcast episodes launched so far.

Targovax ASA: Fourth quarter and full year 2016 results

Oslo, Norway, 16 February 2017 – Targovax ASA (“Targovax” or “the Company”; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces its fourth quarter and full year 2016 results.

A meeting for investors, analysts and press will take place in Oslo today at 10:00 CET and a conference call will take place at 14.00 CET (details below).

Highlights:

Targovax was granted a European Patent for the ONCOS platform lead product, ONCOS-102, extending patent coverage following the award of a similar US patent in June. These patents expire in 2029

Øystein Soug was appointed as CEO on 1 November

Targovax presented at a number of scientific and investor conferences in the period, including the European Society of Gene and Cell Therapy in October in Florence, Biotech and Money in November in London, and the DNB Nordic Healthcare Conference in December in Oslo

Net loss for the fourth quarter 2016 was NOK 32 million (USD 4 million), compared with a net loss of NOK 44 million (USD 5 million) in corresponding quarter in 2015

Cash and cash equivalents at 31 December 2016 was NOK 172 million (USD 20 million) vs NOK 193 million (USD 24 million) at 30 September 2016
Subsequent events:

Targovax announced encouraging top line two-year survival data from TG01 clinical trial in resected pancreatic cancer patients

Erik Digman Wiklund was appointed CFO of Targovax, succeeding Øystein Soug, the Company’s new CEO, and will take up this role in April 2017
Øystein Soug, CEO said: “2016 was a successful year for Targovax. During the year we listed our shares on Oslo Axess, we successfully raised funds to finance the clinical trial program and we were granted European and US patents for ONCOS-102, extending the protection till 2029. Furthermore, in 2016 we prepared and set up five new clinical trials in five indications. 2017 will be an even more important year as we start harvesting the data from these trials. We have already generated good momentum as we recently announced encouraging overall survival data in our TG01 proof of concept trial. We also expect to start a proof of concept trial of ONCOS-102 in checkpoint inhibitor refractory melanoma, where key interim data are expected later in the year.”
Presentation

The presentation will take place at 10:00 CET at:

Hotel Continental

Stortingsgaten 24/26

0117 Oslo

 

The presentation will also be webcast live and can be accessed here.

 

Conference call

At 14:00 CET (08:00 EST) The company will host a telephone conference which will include a presentation of the results, following a Q&A session. CEO Øystein Soug and CMO Magnus Jäderberg will present the company. Call in details can be found below.

Call-in numbers:

Norway Toll-Free Number: 800 19 747

Norway Toll Number: +472350 0559

UK Toll-Free Number: 08082370030

UK Toll Number: +442031394830

US Toll-Free Number: 1866 928 7517

US Toll Number: +1 718 873 9077

 

Access code: 54717166#

 

Please make sure to dial in at least 5-10 minutes ahead to complete your registration.

 

See attached list for more dial-in numbers.

 

Reporting material

The quarterly report and presentation are also available here

 

For further information, please contact

Øystein Soug, CEO

Phone: +47 906 56 525

Email: oystein.soug@targovax.com

 

Media and IR enquires:

Jan Petter Stiff – Crux Advisers (Norway)

Phone: +47 995 13 891

Email: stiff@crux.no

 

Julia Phillips/Simon Conway – FTI Consulting (International)

Phone: +44 20 3727 1000

Email: Targovax@fticonsulting.com

 

Targovax fourth quarter 2016 report
Targovax fourth presentation 2016 report

Photocure – full year report

Oslo Cancer Cluster member Photocure ASA  reported that full year 2016 revenues ended at NOK 143.6 million (134.7). Photocure targets revenues from the US operations to quadruple to a range of USD 15 million by 2020.

“2016 was a positive year for Photocure as we continued to build momentum in the US with Cysview. A significant milestone was reached by the inclusion and recommendations of Cysview in National treatment guidelines in the US. In addition, several papers including strong new clinical evidence supporting the use of Hexvix/Cysview were published during 2016. These events, together with the increase in installed base of Blue Light enabled Cystoscopes in the US and a higher level of patient awareness, provide us with confidence that our planned increase in investment in the US commercial urology franchise will create value for our shareholders in the future. Lastly, we are also looking forward to receiving results from our expanded use Phase 3 study in the US with the Karl Storz flexible scope in the surveillance setting in the middle of the year.” said Kjetil Hestdal, President and CEO.

Photocure reported total revenues of NOK 38.1 million in the fourth quarter of 2016 (34.5), with an EBITDA of NOK -0.3 million (-8.7). Net profit was NOK 17.9 million (-9.4), while the cash position ended at NOK 169.2 million. Hexvix/Cysview revenues grew 13% for the full year but declined 5% in the fourth quarter mainly due to inventory reductions at distributors, as well as a negative impact from foreign exchange rates. In-market unit sales increased with 3% in the quarter.

“Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment. The company has over the last years experienced a strong and growing penetration of Hexvix in key European markets and aims to capitalize on the inclusion in the AUA guidelines as well as the increased patient awareness to significantly increase penetration in the US market. Photocure does however believe that in order to increase market shares in the US to European levels, an investment in the US salesforce is required,” said Hestdal.

The company will therefore double its salesforce and increase sales and marketing expenses accordingly towards the end of 2017. The company believes these efforts will result in revenues from the US operations to quadruple to a range of USD 15 million by 2020.

“As a result of the increased activity level, the added operating expenses will contribute to an EBITDA decline for the group in 2017 and 2018. Photocure is fully funded for this market strategy. Photocure has also completed enrollment in its Phase 3 study of Hexvix/Cysview in the surveillance patient segment and expect to report clinical results in mid-2017. The company will then submit an sNDA to the US FDA, with a possible approval in 2018 for use of Blue Light Flexible Cystoscopy with Cysview in this setting,“ Hestdal concludes.

Photocure is continuing its discussions and due diligence processes with potential partners to establish strategic partnerships for its non-urology products, Visonac and Cevira.

 

Record high attendance at Cancer Crosslinks – watch and dowload presentations

Cancer Crosslinks is now one of the most relevant meetings for Norwegian oncologists, with 300 delegates attending this year.

The 9th Cancer Crosslinks meeting took place at Oslo Cancer Cluster Innovation Park January 26. It was a great success, gathering the Norwegian Oncology Community with a record high attendance of 300 delegates. They came to learn from each other.

– We strongly believe in bringing oncology professionals from various fields together, so that they can exchange knowledge and get to know one another. In doing so, Cancer Crosslinks could contribute to developing new cancer treatments, since this requires collaboration across both medical disciplines and country borders, says Ketil Widerberg, general manager at Oslo Cancer Cluster.

The delegates were mainly oncologists and hematologists. These two professions have traditionally had little interaction, and there is a need to exchange knowledge between these two groups. In addition, there were many other researchers in oncology among the participants, as well as participants from biotechnology companies that develop cancer treatment.

 

Download the presentations

For those of you who missed the event or would like to revisit:

You may watch most of the presentations here:

You can download presentations from the meeting here:

  • Jerome Galon : Opening Keynote – Cancer and Inflammation.
    Prof. Jérôme Galon, Ph.D., Research Director at INSERM; Leader of the INSERM Integrative Cancer Immunology Laboratory, Cordeliers Research Center, Paris, France
  • Seth Coffelt: International Keynote – Inflammation lights the way to metastasis.
    Dr. Seth B. Coffelt, Cancer Research UK Beatson Institute, Institute of Cancer Sciences, University of Glasgow,
  • JRMarchesi: International Keynote – The gut microbiota, inflammation and cancer
    Prof. Julian Marchesi, Imperial College London, UK
  • WWierda: International Keynote: Hematological cancers: how individualized can we treat patients today?
    Prof. William G. Wierda, M.D., Ph.D.; Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA
  • Anna Schuh: International Keynote: The role of clinical -omics for precision medicine approaches in hematology
    Dr. Anna Schuh, Director of Molecular Diagnostics in the Department of Oncology; Honorary Consultant Hematologist at Oxford University Hospitals Trust, UK
  • Guttorm Haraldsen: Inflammation Research in Norway –  core expertise and collaboration opportunities
    Prof. Guttorm Haraldsen, KG Jebsen Inflammation Research Center, Oslo

 

Cancer  and the micro environment
They came to listen to and learn from leading Norwegian and international experts from the US and Europe. One of them was professor Julian Marchesi from Imperial College in London. He gave an exciting talk about the research on cancer, inflammation and the gut microbiota, showing results of how what we eat can affect the gut microbiota and hence cancer development.

Professor Jerome Galon from INSERM Integrative Cancer Immunology Laboratory, Cordeliers Research Center in Paris added to the discussion with a key note talk on the immune micro environment on cancer and a method called Immunoscore[3] .

– Immunoscore is a way to classify cancer patients based on immune parameters . It is then possible to classify patients into high- and low risk groups, says Galon in the podcast Radium.

 

The best treatment for each patient

Professor William G. Wierda from MD Anderson Cancer Centre was another keynote speaker. As an expert in leukemia, he gave insight to the field of precision medicine within hematological cancers. He raised a debate on the question: how individualized can we treat patients today?

Norwegian projects and approaches were also discussed at the meeting. Professor Guttorm Haraldsen, head of KG Jebsen Inflammation Research Center in Oslo gave an overview of Norwegian research and core expertise in the inflammation area. He highlighted opportunities for collaboration with the oncology field.

Another Norwegian example is a project between Dr. Yngvar Fløisand, Senior Consultant, and Dr. Jorrit Enserink, group leader at Oslo University Hospital. They introduced the screening of samples from patients with Acute Myeloid Leukaemia (ALM), to identify the best treatment for each patient. Finally, there was a panel discussion with leading Norwegian experts on the ways forward from data generation to clinical use.
On the previous evening, the delegates participated in thematic roundtables and meetings between Norwegian and international experts. This provided some insight into possible international collaboration in and across their fields of expertise.

 

10 years anniversary next year

This 9th Cancer Crosslinks meeting was kindly sponsored by Oslo Cancer Cluster members  Bristol-Myers Squibb  and AbbVie.

You can look forward to the upcoming Cancer Crosslinks Anniversary Editions: The next Swedish Cancer Crosslinks  meeting will be held in Lund, October 25th (the date will be confirmed) this year and the 10th Norwegian edition will be in Oslo Cancer Cluster Innovations Park in January 2018.

The Economist & Oslo Cancer Cluster: War on Cancer Nordics

Oslo Cancer Cluster is proud to be partner of The Economist Events War On Cancer Nordics.

The War on Cancer Nordics 2017 in Oslo will gather leaders in oncology from the Nordic region and beyond, to discuss the region’s primary challenges in cancer care and control. The event will bring together policy makers, NGOs, academia, research and health care professionals, patient groups and cancer control institutes with private sector business leaders.

 

Questions we will answer

  • How much does cancer cost the Nordic countries per year both in terms of treatment costs and its impact on the labour market?
  • Would a unified Nordic oncology framework be desirable? 
  • What can be learnt from countries that have made more progress in prevention initiatives? 
  • How could research in immuno-oncology be scaled across the region to improve outcomes for patients? 
  • What role will new technologies play in shaking up cancer care, from prevention, through diagnosis, to treatment and to optimise symptoms and quality of life?

 

Founding sponsor: The Research Council og Norway and silver sponsor: Roche

Oncoinvent closes $ 25 Million Private Placement

Our portfolio company Oncoinvent announced today the closing of a 210 MNOK (approx. 25 MUSD) private placement of ordinary shares. Financing will support development of Radspherin™, a novel radiotherapeutic treatment for peritoneal carcinomatosis.

Large privately owned investment companies joining the Company as new investors include Geveran Trading Co. Ltd., Canica AS, CGS Holding AS, Helene Sundt AS and Must Invest AS. Oncoinvent AS is developing therapeutics to combat various cancers based on delivery of tumour-cell killing doses of radiation and/or immunotargeting of tumor cells.

“We are pleased at the response that we have received from the investment community regarding our private placement. The round was heavily oversubscribed. With this financing round we now have, in addition to the new funding, a shareholder base in the company that will enable Oncoinvent to bring Radspherin™ to a clinical proof of concept.” said Jan A. Alfheim, Oncoinvent’s CEO.

About Radspherin™
Radspherin™ is a novel alpha-emitting radioactive microsphere designed for treatment of metastatic cancers in body cavities. The radium based therapeutic, Radspherin™ has shown strong and consistent anticancer activity without any visible signs of product related toxicity in preclinical studies. It is anticipated that the product can potentially treat several forms of metastatic cancer.

The first clinical indication for Radspherin™ will be treatment of peritoneal carcinomatosis originating from ovarian cancer. Peritoneal carcinomatosis is one of the most serious complications of gastrointestinal and gynecological malignancies.

About Oncoinvent
Oncoinvent AS is a privately held Norwegian company based in Oslo, Norway. The company is committed to developing new innovative products in order to provide better treatment options to cancer patients.

The company’s founders started Oncoinvent in 2010 with a view to designing better cancer treatments by applying known physical and chemical principles of selected novel materials in new ways in order to maximize their medical benefit while minimizing potential safety concerns. This approach has allowed the company to develop a rich development pipeline and to explore multiple technological avenues before selecting a lead product candidate for preclinical testing.

www.oncoinvent.com

 

7 Oslo Cancer Cluster members granted funding from the Research Council

The Norwegian Research Council recently granted  funding to Oslo Cancer Cluster members; BerGenBio, Bionor Immuno, GE Healthcare, Lytix Biopharma, PCI Biotech, Zelluna  and Phoenix Solutions through the Programme for User-Driven Research Based Innovation (BIA).

In total, the Research Council will grant 406 MNOK  to 42 Norwegian companies in this application round. A total of 187 applications was filed.

Overview of member companies and their funded projects:

Funding from the  BIA programme is a quality stamp since the companies compete in “open class” where all sectors are represented. On the Research Council`s website you may find the total list of all the 42 companies (in Norwegian) and read more about the funding from the BIA-programme.

Targovax with full year report

Oslo Cancer Cluster member Targovax will announce its fourth quarter and full year 2016 results on Thursday, 16 February 2017. A presentation by Targovax’s management to investors, analysts and the press will take place in Oslo at 10:00 CET.

The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 CET.

Presentation

The presentation will take place at 10:00 CET at Hotel Continental. The presentation will also be webcast live and can be accessed through www.targovax.com.

 

 

 

About Targovax

Targovax is a clinical stage company focused on developing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

 

The Company’s development pipeline has arisen from two novel proprietary platforms:

The first platform, ONCOS, uses oncolytic viruses, an emerging class of biological therapy. ONCOS exclusively uses an adenovirus that has been engineered to be a tumor-targeted immune activator. The platform has the potential to generate therapies with superior efficacy and safety compared to the first approved oncolytic virus therapy, Imlygic, recently launched by Amgen. We expect proof of concept data related to immune activation in tumor tissue in 2017 from the clinical trial of ONCOS-102 in combination wih CPI in patients with refractory malignant melanoma.

The second platform, TG-Peptides, solely targets tumors that express mutated forms of the RAS protein. Mutations to this protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations. The TG platform’s therapeutic potential stems from its ability to enable a patient’s immune system to identify and then destroy tumors bearing any RAS mutations.

The development pipeline has three novel therapeutic candidates in clinical development covering six indications and has already demonstrated promising safety and tolerability data and early signs of clinical response.

Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost effective manner. Our portfolio of future opportunities comprises a number of early stage development candidates in addition to the three outlined above.

In July 2016 the Company listed its shares on Oslo Axess, securing funding for further development of the Company’s ongoing and planned trials.

 

 

Lytix Biopharma granted 15.9 MNOK from The Research Council of Norway

Lytix Biopharma, a clinical-stage biopharmaceutical company developing novel cancer immune therapies, has been awarded a NOK 15.9 million grant from The Norwegian Research Council (User-driven Research-based Innovation) to support the investigation of LTX-315’s ability to make ’’cold tumors hot’’ and Phase II trial in Triple Negative Breast cancer (TNBC).

Recent developments in immunotherapy have demonstrated a significant clinical impact in the field of cancer treatment. However, it is well known that immune therapy works better when there are immune effector cells present in the tumour microenvironment compared to if they are absent. When the tumour lacks immune effector cells, they are called “cold” and when immune effector cells are present they are named “hot”. Preclinical studies have shown that the Lytix compound LTX-315 has the potential  to make cold tumours hot and thus increase the overall patient response of combinations with other cancer treatments, for example immune checkpoint inhibitors.

Forty-two patients have so far been treated with LTX-315 alone, in two Phase I trials, and positive signals from these patients form the basis for this project. The primary objective for this project is to document in both preclinical and clinical studies that LTX-315 increase the infiltration of immune effector cells in the tumour and make the “cold” tumour “hot” in combination with immunotherapy. The clinical study will be performed in patients with Triple Negative Breast Cancer, a subtype of breast cancer. These patients have today limited treatment possibilities and the medical need for better treatments is high.

Håkan Wickholm, CEO of Lytix Biopharma says, -We are very pleased that the Research Council shares our view of the potential of LTX-315 and supports our work to give cancer patients a better treatment response.

Targovax announces encouraging top line two-year survival data from TG01 clinical trial in resected pancreatic cancer patients

Survival rate of 68% from first patient cohort vs published historical rate of 30-53% suggests signal of clinical efficacy for the drug candidate. Full data set from first patient cohort to be submitted for presentation at ASCO annual meeting in June.

Oslo, Norway, 2 February 2017 – Targovax ASA (“Targovax” or “the Company”; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces encouraging overall survival data from an analysis of the first cohort of patients in its ongoing, phase I/II clinical trial evaluating TG01 (co-administered with GM-CSF[1]) in resected pancreatic cancer given in combination with chemotherapy, gemcitabine, the current standard of care, study CTTG01-01.
Data from this patient cohort showed that 68% of evaluated patients (13/19) were still alive after two years if survival is counted from time of resection which occurred on average two months prior to first treatment, or 12/19 if counted from time of first treatment. While the cohort is small and there is no control arm, this rate compares favorably with the available published historical two-year survival rates of resected cancer patients treated with gemcitabine alone of between 30% and 53% (J Neoptolemos 2010, J van Loethem 2010, H Oettle 2013, M Sinn 2015, K Uesaka 2016; In these reported studies Overall Survival measured either from surgery or treatment randomization).
Dr Magnus Jäderberg, Chief Medical Officer of Targovax commented, -We are encouraged by the two-year overall survival rate of patients treated with TG01 in this trial, versus the expected rate from published historical data when treating with gemcitabine alone, the current standard of care. Whilst acknowledging the small size of this first patient cohort and the lack of a control arm, we are encouraged by what seems to be a signal of efficacy in this highly malignant and difficult to treat cancer. This key milestone for Targovax also triggers a further iteration of plans for the future clinical development of TG01. We have submitted an abstract to the ASCO annual meeting in June when we plan to present the full data.
CTTG01-01 is an open label study conducted in four centres in the UK and Norway. A first cohort of 19 patients each received 36 injections of TG01/GMCSF synchronised with six cycles of gemcitabine and have now completed the study. The main objectives of the study are an assessment of safety and immune activation. The secondary objective is to assess efficacy (disease-free survival and overall survival) at two years. The Company has received consent to enable the reporting of overall survival for all patients in the cohort. CTTG01-01 has been financially supported, in part, by The Research Council of Norway and Innovation Norway.
TG01 is Targovax’s first product to arise from its TG-Peptide platform. The platform yields injectable peptide-based onco-immunotherapies that are designed to treat patients whose tumors express RAS mutations. These mutations are associated with poor prognosis when present. By inducing immune responses in such cancer patients, TG-peptide immunotherapies have the potential to prolong the time to disease progression and to increase survival. RAS mutations are common in a number of cancers. Published data reports 85% of pancreatic cancer cases have such mutations.

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com

Media and IR enquires:
Jan Petter Stiff – Crux Advisers (Norway)
Phone: +47 995 13 891
Email: stiff@crux.no

Julia Phillips/Simon Conway – FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax@fticonsulting.com

Lytix Biopharma granted 15.9 MNOK from The Norwegian Research Council

Oslo Cancer Cluster member Lytix Biopharma has been awarded a NOK 15.9 million grant from The Norwegian Research Council (User-driven Research-based Innovation) to support the investigation of LTX-315’s ability to make ’’cold tumors hot’’ and Phase II trial in Triple Negative Breast cancer (TNBC).

Recent developments in immunotherapy have demonstrated a significant clinical impact in the field of cancer treatment. However, it is well known that immune therapy works better when there are immune effector cells present in the tumour microenvironment compared to if they are absent. When the tumour lacks immune effector cells, they are called “cold” and when immune effector cells are present they are named “hot”. Preclinical studies have shown that the Lytix compound LTX-315 has the potential  to make cold tumours hot and thus increase the overall patient response of combinations with other cancer treatments, for example immune checkpoint inhibitors.

Forty-two patients have so far been treated with LTX-315 alone, in two Phase I trials, and positive signals from these patients form the basis for this project. The primary objective for this project is to document in both preclinical and clinical studies that LTX-315 increase the infiltration of immune effector cells in the tumour and make the “cold” tumour “hot” in combination with immunotherapy. The clinical study will be performed in patients with Triple Negative Breast Cancer, a subtype of breast cancer. These patients have today limited treatment possibilities and the medical need for better treatments is high.

Håkan Wickholm, CEO of Lytix Biopharma says: ‘We are very pleased that the Research Council shares our view of the potential of LTX-315 and supports our work to give cancer patients a better treatment response.’’

www.lytixbiopharma.com

Phoenix Solutions granted NOK 15.8 million from the Research Council of Norway

Our member Phoenix Solutions has been granted NOK 15.8 million from the Research Council of Norway to the project “ACT for Pancreatic Cancer”.

The main goal of the project is to provide clinical proof-of-concept for Phoenix`s Acoustic Cluster Therapy (ACT®) technology, in a study where ACT® is combined with current standard of care chemotherapy for treatment of pancreatic ductal adenocarcinoma. Prior to start clinical trials, the project will also include further preclinical work, establishment of GMP manufacture and execution of regulatory safety studies.

“This funding will enable us to push on with our project to fight pancreatic cancer and meet a key developmental milestone; execution of a clinical phase I/IIa program from mid-2018. Together with partners at Institute of Cancer Research / Royal Marsden Hospital (UK) and Haukeland University Hospital, we strongly believe that ACT® can make a significant difference for patients with this hard to treat, deadly disease.”, says CEO in Phoenix Solutions, Per Sontum.

The project will be initiated in Q1 2017 and run for four years. The grant will cover approx. 35% of the project costs. The grant is subject to final contract negotiations.

Established in 2006, the BIA programme is the largest industry-oriented programme at the Research council of Norway (Forskningsrådet). This broad-based programme supports high-quality R&D projects with good business and socio-economic potential.

About Phoenix Solutions: 

Phoenix Solutions is a Norwegian biotech company sprung out from GE Healthcare in 2013, currently developing a technology platform for targeted drug delivery – Acoustic Cluster Therapy (ACT®). ACT® is a unique approach to ultrasound mediated, targeted drug delivery – capable of enhancing significantly the clinical utility of a wide range of therapeutic molecules and nano-drugs for a wide range of clinical indications. Its primary mode of action is in defeating the vascular barrier, enhancing extravasation, distribution and uptake of drug in the targeted tissue, thereby increasing efficacy and/or reducing toxicity.

ACT® is generally indicated towards diseases where current clinical practice treats known, localized pathologies (e.g. solid tumours) with medicinal therapy, and where Standard of Care is being limited from an inability to deliver sufficiently high concentrations of drug to the tumour without excessive systemic toxicity. Phoenix is currently targeting the oncology segment, looking in particular at pancreatic, liver, triple negative breast and prostate cancers, and has extremely promising preclinical results so far.

www.phoenixsolutions.no  

PCI Biotech granted NOK 13.8 million from the Research Council

Our member PCI Biotech has been granted NOK 13.8 million to the project “Photochemical vaccination – novel immunotherapy concept for treatment of cancer and infectious diseases”.

The main goal of the project is to document in a proof-of-principle clinical study in cancer patients that PCI Biotech’s photochemical internalization (PCI) technology can be used to improve the efficacy of a therapeutic cancer vaccine. Other important aspects of the project is to develop the PCI technology for use in vaccination against certain types of viral and bacterial infections, and to explore the technology for use with mRNA-based vaccination.

‘This grant supports further development of the promising fimaVacc technology, as well as the important vaccination application of the fimaNAc technology. Both of these applications are well suited for the development of new types of immunotherapy against cancer, and also for the prevention and treatment of some types of infectious diseases, including certain types of chronic virus infections. We are very pleased to see that the expert evaluators and the Research Council share our view on the potential of these technologies.’ says CEO in PCI Biotech, Per Walday.

The project will be initiated in Q3 2017 and run for three and a half years. The grant will cover up to 35% of the project costs and the project will be implemented in the company’s current plans. The grant is subject to final contract negotiations.

Established in 2006, the BIA programme is the largest industry-oriented programme at the Research council of Norway (Forskningsrådet). This broad-based programme supports high-quality R&D projects with good business and socio-economic potential.

About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

www.pcibiotech.no

Cancer Crosslinks 2017 will be streamed

Cancer Crosslinks 2017 on January 26th features a really interesting program with presentations from international and Norwegian thought leaders within cancer research.

For those of you that may not be present at the conference in the Oslo Cancer Cluster Innovation Park, you may watch the presentations as we will live stream from 9:15 – 16:15.

Close to 250 participants from all over Norway have signed up for this years Cancer Crosslinks. The program for the 9. th Cancer Crosslinks is divided in three parts; recent findings regarding cancer & inflammation, personalised cancer medicine within hematological cancers and the emerging field of real-world evidence.

Cancer Crosslinks is hosted by Oslo Cancer Cluster and sponsored by BMS and AbbVie.

Five members granted funding by Innovation Norway

To stimulate collaboration between companies in the Oslo Cancer Cluster, we have through Innovation Norway´s funding scheme *Innovasjonsrammen*  granted five member companies project funding between NOK 500.00 – 100.000,-.

PCI Biotech, Ultimovacs, Arctic Pharma, Oncoimmunity and MyHere are the said companies, and they  will all use the funding to develop improved cancer treatments. Read more about the projects below.

Ketil Widerberg, CEO of Oslo Cancer Cluster, commented: “Oslo Cancer Cluster encourages collaboration between companies. We highly appreciate that Innovation Norway has a funding scheme like *Innovasjonsrammen* that enables us to fund  projects that may drive collaboration and innovation to develop innovativ cancer treatments.”

 

Joint project PCI Biotech and Ultimovacs:
PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, and it’s partner Ultimovacs, a pharmaceutical company developing novel immunotherapy against cancer, received funding of NOK 500.000,- for further development of the existing preclinical research collaboration. The purpose of the collaboration is to utilise the companies’ complementary scientific platforms to explore potential synergies and the grant will support these activities.
Read press release here.

 

Arctic Pharma and Oslo University
Arctic Pharma’s main objective is to develop therapies for breast cancer (triple-negative subtypes) that to date have non-specific treatments and the poorest survival outcome. Arctic Pharma will create therapies that kill cancer cells by attacking the core of their metabolism, and was granted NOK 100.000,- in their effort together with University og Oslo, to test and characterize their most promising therapies, which they are in the process of patenting.

 

 

OncoImmunity and partners
OncoImmunity provides innovative software solutions to guide the discovery of neoantigen-based personalized immunotherapies and biomarkers. One of the major challenges to overcome is the accurate identification of immunogenic peptides in the tumor, and their precise constellation on a personalized vaccine. In this project OncoImmunity and partners were granted NOK 300.000,- to develop a software framework to predict the peptides that confer maximum immunogenicity with minimum autoimmune side-affects to a patient.

 

Myehere and partners
Myhere and partners were granted NOK 100.000,- for a pilot study.

 

Dehns is now member of the Oslo Cancer Cluster

Dehns Patent and Trade Mark Attorneys recently joined the Oslo Cancer Cluster.

Dehns is one of Europe’s largest firms of patent and trade mark attorneys and has a 40 year history of working with Norwegian organisations such as: Dynal, Inven2,Lytix Biopharma, Nextera, NMBU, NTNU, Nycomed, PCI Biotech and Photocure.

As members, our aim is to advise and help protect the other members needs regarding innovations and intellectual property (IP) around cancer research, diagnosis and treatment.

With experts in this field, many of whom also have PhDs, we can help you build and manage your IP portfolio and strategy, including providing advice on the patentability of inventions, draft and file patent applications, represent you in opposition and other contentious proceedings, as well as advise on academia-industry collaborations and licensing agreements.

www.dehns.com

 

The PCI Biotech and Ultimovacs collaboration awarded NOK 500,000 from Innovation Norway

The PCI Biotech and Ultimovacs collaboration awarded NOK 500,000 from Innovation Norway

Oslo (Norway), 6 January 2017 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, and Ultimovacs, a pharmaceutical company developing novel immunotherapy against cancer, today announced that they are awarded NOK 500,000 for further development of the existing preclinical research collaboration. The purpose of the collaboration is to utilise the companies’ complementary scientific platforms to explore potential synergies and the grant will support these activities. The Innovation Norway grant of NOK 500,000 is awarded for 2017 and the grant is made available through Oslo Cancer Cluster a Norwegian Centre of Expertise.

Please see attached press release for further details.

Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo, Norway. www.pcibiotech.com
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

 

Lytix enrols first patient in LTX-315/anti-PD1 combination study

The immune oncology company Lytix Biopharma AS has enrolled the first patient in the Phase 1 study of LTX-315 in combination with immune checkpoint inhibitors (ICIs). Since LTX-315 turns immunogenically “cold” tumours “hot” it may be an ideal combination with other immunotherapies.

The majority of cancer patients do not respond to marketed immunotherapies when given as monotherapy. The promise of combination immunotherapy is that it may improve the response rate observed with ICIs.

LTX-315 is a novel first-in-class oncolytic peptide immunotherapy in development for the treatment of solid tumours as triple negative breast cancer (TNBC) and malignant melanoma. As monotherapy, LTX-315 has demonstrated a significant increase in CD8 T cells infiltration in injected tumours. Since LTX-315 is turning immunogenically “cold” tumours “hot” it has the potential to enhance the proportion of patients responding to ICIs.

Håkan Wickholm, Lytix Biopharma CEO, commented, -We look forward to gaining further understanding of the potential for LTX-315 as a key component in immunotherapy. Due to LTX-315’s ability to induce strong and diverse tumour specific T cell responses, we believe it is an ideal combination partner for ICIs.

Andrew Saunders, Lytix Biopharma CMO, commented, -LTX-315 can make immunogenically “cold” tumours “hot” and has demonstrated strong synergy in combination with ICIs in preclinical experiments. This represents a strong rationale for us to evaluate this combination in cancer patients.

The Phase 1 trial is designed to investigate the safety and efficacy of LTX-315 in combination with either anti-PD1 or anti-CTLA4 Immune Checkpoint Inhibitor (ICI) antibodies in either Triple Negative Breast Cancer (TNBC) or malignant melanoma. The first patient enrolled in the study is a TNBC patient that will receive LTX-315 in combination with anti-PD1. LTX-315 is injected twice a week for 3 weeks, and a total of 14 investigational sites in Europe are participating in the study.

The Phase 1 study is an open-label, multi-arm, dose escalation study of LTX-315 as monotherapy or in combination with either anti-CTLA4 or anti-PD1 in patients with transdermally accessible tumours with the aim of identifying an optimal dose regimen to take into Phase 2.

Recent data indicate that in a Phase 1 trial population with advanced/metastatic tumours, LTX-315 is generally well tolerated with complete and partial regression in 31% of injected tumours and stable disease (SD) in 50% of evaluable patients.
For further information, please contact:

Håkan Wickholm, Chief Executive Officer

Targeted drug delivery platform company Phoenix Solutions AS completes its Series A financing

The Board of Directors of Phoenix Solutions is pleased to announce that the company has completed a series A financing led by a small group of healthcare angel investors. CEO Per Sontum, -We are very pleased to announce this first round of financing. This funding will give us the ability to reach a key developmental milestone for our preclinical work in pancreatic cancer.

Phoenix Solutions is a Norwegian bio-tech company sprung out from GE Healthcare in 2013, currently developing a technology platform for targeted drug delivery – Acoustic Cluster Therapy (ACT®). ACT® is a unique approach to ultrasound mediated, targeted drug delivery – capable of enhancing significantly the clinical utility of a wide range of therapeutic molecules and nano-drugs for a wide range of clinical indications. Its primary mode of action is in defeating the vascular barrier, enhancing extravasation, distribution and uptake of drug in the targeted tissue, thereby increasing efficacy and/or reducing toxicity. ACT® is generally indicated towards diseases where current clinical practice treats known, localized pathologies (e.g. solid tumours) with medicinal therapy, and where Standard of Care is being limited from an inability to deliver sufficiently high concentrations of drug to the tumour without excessive systemic toxicity. Phoenix is currently targeting the oncology segment, looking in particular at pancreatic, liver, triple negative breast and prostate cancers, and have had extremely promising preclinical results so far.

 

For further information, please contact: Per Christian Sontum, CEO of Phoenix Solutions AS

E-mail: Per.Sontum@phoenixsolutions.no

Mobile: +47 47261042

Prime Minister Erna Solberg´s speech to Oslo Cancer Cluster

Oslo Cancer Cluster celebrated it´s 10 years anniversary in December with almost 170 guests, the Prime Minister Erna Solberg, State Secretary Dilek Ayhan, several Members of the Parliament, General Secretary of the Norwegian Cancer Society Anne Lise Ryel and representatives from the governmental agencies SIVA, Innovation Norway and the Research Council. 

At the anniversary seminar, Prime Minister Erna Solberg gave a speech where she honoured the work that the cluster has done so far to contribute to the development of innovative cancer treatments.

The Prime Minister also revealed to the acclamation from the audience,  that the financing in the future is secured through the Research Council. This funding comes in addition to the earmarked funding to health clusters in the State Budget for 2017 that Oslo Cancer Cluster also may apply for.

Anne Lise Ryel, General Secretary of the Norwegian Cancer Society also gave a wonderful speech to cluster. 

 

Below you may read Erna Solberg´s speech,  published on regjeringen.no

 

Speech by Prime Minister Erna Solberg at Oslo Cancer Cluster 13 December 2016.
By Statsminister Erna Solberg

First of all, I would like to wish you happy anniversary, Oslo Cancer Cluster!

Congratulations to all of you who have contributed to the development of what OCC stands for today, and what OCC will be in the future.

Oslo Cancer Cluster Innovation Park has developed into  an important meeting place for cancer research, innovation and education.

You host activities throughout the value chain: basic research, clinical trials, innovation, commercialisation and most importantly implementation of new knowledge in clinical pracice.

I’m sure the Oslo Cancer Cluster Innovation Park will also play an important role in shaping future cancer treatments and as an innovative environment for researchers.

Cancer is the disease area that receives most of the research funding both nationally and regionally.

This investment produces results in the form of new treatment that benefits cancer patients – for example,

Personalised medicine is gradually being implemented in the treatment of cancer patients.

Immunotherapy is a new revolutionary development in cancer treatment which is thought to have an even larger impact on cancer treatment in the future.

Protontherapy may be more effective and reduce the extent of damage to surrounding organs and tissues.

I am well aware that behind these key developments are many years of hard work in research. Thank you all for contributing!

We can still bring even more of the investments we make in research to the patients, through increased focus on collaboration between the health sector and industry in clinical research, innovation and commercialization of research results.

The importance of this collaboration is discussed in several documents. Let me mention the Government’s White Paper on medicines, the HealthCare21 strategy and  the Government Action Plan for implementation of the Health&Care21 Strategy.

The health and care sector is of great importance in our society. This is a sector where knowledge, new technology and demographic development lead to rapid changes and restructuring.

The patient and her needs is to be at the centre of these changes.

Research and innovation is instrumental when aiming for higher patient quality, development of better health and care services and more effective and affordable treatment.

Research and innovation also lays the foundation for new business development.

For the first time in Norway, the major actors in the health industry have joined forces and developed a report  aiming at describing the entire health industry in numbers. This report from Menon this year says among other things that the health industry in Norway:

  • exported for about 20 billion Norwegian kroner in 2015,
  • had a strong revenue growth in 2015 of 11 percent,
  • that research and development efforts in the health sector is at least 2.5 billion Norwegian kroner.

I believe that the health industry may play an important role in the Norwegian economy. Accordingly, this Government has decided that health is a priority in industrial policy development.

In this context, it is of  importance to develop strong clusters. OCC is an important example of international renown cancer cluster in Norway today.

We have many types of policy instruments and tools in order to achieve our objectives in developing and strengthening Norwegian industries through the Research Council and Innovation Norway.

OCC plays an important role in creating cooperation arenas between users, public sector, health authorities, private sector and research communities.

I am pleased to let you know that the Research Council has informed me that it will provide funding to OCC,  granted that the criteria from the State Aid Guidelines are fulfilled.

Furthermore, next year’s national budget contains a proposal to strengthen the clusters – and with a particular focus on health-related research and innovation. This in turn should provide for additional options for  clusters to apply for project funding.

I look forward to follow your work in the years to come.

Again happy anniversary!

Norwegian Cancer Society honours Oslo Cancer Cluster

Anne Lise Ryel, General Secretary of the Norwegian Cancer Society gave a powerful speech at the celebration of Oslo Cancer Cluster´s 10 years anniversary. Here she stresses the importance of collaboration and ensures the continued support to the cluster. 

 

OSLO CANCER CLUSTER 10 ÅR

HILSEN VED GENERALSEKRETÆR ANNE LISE RYEL, KREFTFORENINGEN

13. DESEMBER 2016

 

 

Prime Minister,

Deputy Minister,

Members of the Parliament,

Friends of OCC,

Friends of the cancer case,

Dear all of you,

 

1.

I have a dream.

A dream that Norway expand the investment in, and starts building a sustainable innovative health industry.

Why: For the better of the nation, creating value, creating work places, and of course, needless to say;

for better treatment and quality of life for future patients.

I have a dream that we in doing so, we combine our expertise and excellence in technology from the oil and gas sector with medicine and healthcare.

Pumps and pipes.

I think I share this dream with many, hopefully also with our prime minister.

 

2.

I have a dream.

A dream that this health industry – being so massive – will focus on cancer.

In this field we have unique possibilities and benefits for national and global success.

 

Such as:

-Some excellent research groups

-A national cancer registry

-Population surveys

-Bio banks

-A national ID number

-A homogenous population

 

People trust in the healthcare system/sector

People want to participate in clinical trials

Systems for including the user´s perspective

 

Obama also shares this dream.

To combat cancer with help of research and innovation and industry.

And to help fulfill his dream he looks to Norway.*

 

He looks to where we are now, to this very spot!

 

3.

I have a dream.

A dream that this campus ­ – with Radium Hospitalet, with its clinics, research institutions, Oslo Cancer Cluster, Oslo Cancer Cluster Innovation park, startups, the school, The Cancer Registry, the Vardecenter for patients – becomes a Comprehensive Cancer Center.

This will attract the best global minds and the best ideas, and money.

It’s here in Oslo, in the capital.

But it is national.

Like OCC is national. It’s a Norwegian cluster.

 

4.

I have a dream that we will continue to build on the Nordic model.

A model with three parties.

Public, private and NGOs.

Together we cover a broader perspective, we contribute with our unique strengths, we play different roles.

Together we gain more.

I say Nordic model, because the most common model globally is the two sectors together: public and private.

 

The Nordic countries have realized that organizations like the Norwegian cancer society, NGOs within the health sector,

Always have, from their very start, been innovative.

Always tried to find solutions to the needs voiced by citizens and patient groups.

 

Therefore we think and hope that we have a role to play. That we can contribute. In general. In the healthcare sector.

 

5.

And that’s why the Norwegian cancer society has been a supporter of OCC from the start and a member from an early stage.

Hopefully we have facilitated contact with other actors, hopefully we have opened some doors, hopefully we have been good ambassadors.

 

6.

Today OCC is 10 years of age.

It has grown from a baby to becoming a teenager.

The expectations might change a bit.

The challenges might be a bit different in the future.

But with a growing strength, more can be gained, and more value added to the role of being a cluster.

 

We will continue to support you. Perhaps also in new ways.

We see the need of a common ground, a place where all the actors can meet and mingle and join and create.

Otherwise, neither my nor others´ dreams will come true.

 

I will make Henry Ford’s words mine:

Coming together is a beginning, keeping together is progress, working together is success.

 

7.

My colleague googled to find out what a 10-year-old would like as a gift.

The answer was the game «How to become a millionaire». The combination knowledge + ideas + creativity is a way to money. Both in games and real life.

A perfect gift for you!

 

Congratulations!

 

 

 

Photo of Martin Bonde, Vaccibody

Vaccibody raised MNOK 220

Oslo Cancer Cluster member Vaccibody succesfully raised NOK 220 million (€ 24 million). The Private Placement was significantly oversubscribed by both existing shareholders and new investors.

The net proceeds from the Private Placement will be used to conduct Vaccibody’s early stage clinical development plan for personalized cancer neoantigen vaccines (two phase I/Ib trials) and for general corporate purposes.

Martin Bonde, CEO of Vaccibody, said: “We are grateful for the confidence in, and commitment to, the Company from our new investors as well as our existing investors. With the investment we will be able to pursue our ambition of making an entirely novel therapy available. In collaboration with expert clinicians we will work to initiate clinical trials with our to cancer neoantigen vaccines to show benefit in patients suffering from advanced and severe cancer”.

 

www.vaccibody.com

Update: PERMIDES 1st European Workshop

Oslo Cancer Cluster organized and hosted the ‘1st European Workshop : PERMIDES H2020 Project‘ on 06th December 2016 @ Jónas Einarsson Auditorium, in collaboration with NCE Smart & on behalf of the PERMIDES consortium.

More than 30 delegates from Biopharma, IT and Bioinformatics companies mostly from the Nordic countries actively discussed their innovation barriers and needs along the personalised medicine value chain and digital health revolution. MediSapiens (Finland) and eSmart Systems (Norway) gave stimulating presentations on Digitization of bio-business, Big Data Analytics & Machine Learning aspects. Oslo Cancer Cluster kickstarted the group discussions with an introduction to PERMIDES consortium, the Value Chain Challenges & Topics for Innovation Projects.

During the later half of the workshop, moderated group discussions prioritised the key challenges of biopharma SMEs which can be addressed with the implementation of IT solutions and automatised processes. The workshop thereby provided valuable input for the PERMIDES Innovation Project calls to be launched during the first quarter of the year 2017. In addition, it provided initial matchmaking between participants from the biopharma and IT sector.

Currently we are developing the PERMIDES online platform, where biopharma – IT & bioinformatics SMEs can identify suitable partners to jointly apply for Innovation Vouchers allowing them to address their value chain challenges. For more information, please visit: PERMIDES

 

Given below is the glimpse of the workshop agenda:

agenda

 

For further information and discussions, please contact:

gu-jh

Nordic Nanovector raised 500 MNOK

Nordic Nanovector  has raised MNOK 500 in gross proceeds through a private placement of 4,374,244 new shares. 

 

Nordic Nanovector intends to use the net proceeds to:

– To fund a Phase 2 combination study of Betalutin® and Rituximab CD20
– To fund a Phase 1 study and GMP manufacturing for 177Lu-conjugated chimeric antibody (anti-CD37 ARC)
– Develop new proprietary antibody production technology
–  Accelerate pipeline of pre-clinical assets to clinical trials
–  Prepare for commercial launch of Betalutin®
–  General corporate purposes
The Private Placement and the issuance of the new shares was resolved by the Company’s Board of Directors (the “Board”) at a board meeting held on 6 December 2016, based on the authorisation granted to the Board at the Company’s annual general meeting on 19 May 2016. Notification of allotment in the Private Placement and payment instructions will be sent to the applicants today through a notification from the Joint Bookrunners. The new shares will be settled delivery versus payment on 9 December 2016 (regular T+2 settlement), by delivery of existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange pursuant to a share lending agreement between DNB Markets (on behalf of the Joint Bookrunners) and HealthCap VI L.P. The new shares delivered to the subscribers will thus be tradable from allocation.

Following registration of the new share capital pertaining to the Private Placement in the Norwegian Register of Business Enterprises, expected to take place on or about 13 December 2016, the Company will have an issued share capital of NOK 9,794,924, divided into 48,974,618 shares, each with a par value of NOK 0.20.

The Board has assessed the Private Placement in light of the equal treatment requirement, balanced the considerations that speak for and against carrying out the Private Placement and concluded that the waiver of the preferential rights inherent in a private placement was considered necessary in the interest of time and successful completion in the common interest of the Company and its shareholders.

 

 

 

About Nordic Nanovector:

Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.

Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab, conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.

Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its pipeline of innovative targeted immunoconjugate therapies for multiple selected cancer indications.

Further information about the Company can be found at www.nordicnanovector.com

This information is subject to the disclose requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

 

Utplassering med uttelling

Gjennom det skolefaglige samarbeidet mellom Oslo Cancer Cluster og Ullern videregående skole har realfagselever hatt en ukes utplassering på avdeling for Tumorbiologi ved Institutt for Kreftforskning ved Oslo universitetssykehus i 7 år.

 

I år er de heldige elevene som får være med kreftforskerne i sitt dagligvirke; Marie, William, Ondrej, Julie, Louise og Anine.

Da vi stikker innom på andre dag av utplasseringen er elevene i gang med å skille brystkreftceller og føflekkreftceller ved hjelp av magnetiske Ugelstadkuler. Kulene er dekket med ulike antistoffer som gjenkjenner enten bryst-spesifikke proteiner eller føflekk-spesifikke proteiner.

-Vi har søkt utplassering selv for vi har veldig lyst til å kunne ta i bruk det vi har lest om på skolen mer i prakis, sier Louise. Hun var og på utplassering i fjor på Folkehelseinstituttet.

-Det er veldig spennende å lære mer om hva man gjør på en lab og hva det arbeidet går ut på, sier Marie.

De er skjønt enige om at et arbeidsliv som forsker eller lege kunnevære veldig spennende, og alle seks har biologi og kjemi på skolen.

Etter å ha jobbet en del to og to med prøver i laben for å få fram en væske som skal bestå av Ugelstadkuler som har festet seg til kreftceller, går gjengen videre inn på mikroskopirommet for å kikke på prøvene de har jobbet med, samt en negativ prøve for å sjekke at de har gjort eksperimentet riktig.

-Det er mye håndarbeid på en lab. Det er nok veldig uvant for elevene, sier Siri Tveito som er kreftforsker og har ansvaret for elevene denne uken sammen med Karen-Marie Heintz.

-Men de er dyktige og blir flinkere til å pipettere hver dag som går, sier Tveito som har vært med på utplasseringene siden 2012.

Det som skiller utplasseringen på tumorbiologien fra de andre utplasseringene som Ullernelvene kan søke på, er at den varer en hel uke og er veldig praktisk lagt opp slik at elevene får teste ut mye selv på laboratoriet.

-Det er kjempegøy, og absolutt noe som jeg kunne tenke meg å gjøre videre, sier Ondrej.

Han forteller at han liker å finne ut av nye ting, og at det ser veldig fristende ut å bli forsker basert på nettopp det.

-Det er klart at det blir mye skole å ta igjen etter en uke på utplassering, men det er absolutt verdt det, sier Ondrej.

 

 

Ullern skole og Oslo Cancer Cluster tilbyr syv utplasseringer i året til elever som tar realfag og media. Utplasseringene får virkelige gode tilbakemeldinger fra elevene og mange forfølger et yrke som forsker eller lege etter realfagsutplasseringene.

 

 

Single-dose Betalutin® shows promising efficacy

Nordic Nanovector ASA presented the updated results from its ongoing Lymrit 37-01 Phase 1/2 clinical trial of Betalutin® (177Lu-satetraxetan-lilotomab) in subjects with relapsed non-Hodgkin lymphoma (NHL) at the 58th Annual American Society of Hematology (ASH) meeting (San Diego, CA, USA).

 

The updated data confirm Betalutin®’s promising efficacy and favourable safety profile as a single agent in 38 relapsed NHL patients, having failed multiple prior regimens and being eligible for assessments. The results, based on the data cut-off date of 31 October 2016, were presented by the study’s Principal Investigator Dr. Arne Kolstad from the Department of Oncology at the Oslo University Hospital, Radiumhospitalet.

Key conclusions:

• In the 35 patients evaluable for efficacy, the Overall Response Rate (ORR) was 63%, with 29% Complete Responses (CR)

• The 21 evaluable patients in the study who received Betalutin® at the dose of 15 MBq/kg with 40 mg/m2 lilotomab pre-dosing had an ORR of 62% and a CR of 38%; of these, the 16 patients enrolled in the Phase 2 expansion of Arm 1, had an ORR of 69% and a CR of 38%

• Durable responses have been observed with a median duration of response of 20.7 months for all patients in Arm 1

• Betalutin® is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible

• No dose-limiting toxicity (DLT) was reported in Arm 4 (15 MBq/kg Betalutin® plus 100 mg/m2 lilotomab pre-dosing) and this regimen demonstrated lower bone marrow toxicity than Arm 1, 2 and 3. Arm 4 is now enrolling patients to evaluate the higher dosing regimen of 20 MBq/kg Betalutin® plus 100 mg/m2 lilotomab.

The Lymrit 37-01 study is a Phase 1/2 open label, dose escalation study investigating the optimal lilotomab pre-dosing and Betalutin® regimen in patients with relapsed NHL. Data from 38 patients are presented.

Dr. Arne Kolstad, MD commented -The results we are presenting today are very encouraging and continue to highlight the potential of Betalutin® to provide a new treatment option for NHL patients. These patients, particularly those who fail standard CD20-targeted immunotherapy and/or are too frail to receive chemotherapy, are desperately in need of alternative therapies that work through different and complementary mechanisms and are well tolerated. Betalutin® is showing exciting promise in an increasing number of NHL patients and we look forward to the results from future studies that will hopefully confirm its attractive profile.

Dr. Lisa Rojkjaer, MD Nordic Nanovector’s Chief Medical Officer, commented -These new data confirm the promising results for Betalutin®, including durable responses in a number of patients, which were presented earlier this year at the AACR meeting, and continue to demonstrate an encouraging clinical profile as a single agent for treating patients with relapsed NHL. The results also support escalating to a higher dosing regimen in the final stages of this Phase 1/2 study that will allow us to decide an optimal dosing regimen for the pivotal Phase 2 study, PARADIGME, expected in Q1 2017.

The poster (abstract 1780) was presented on Saturday, 3 December 2016 between 5:30PM–7:30PM Pacific Standard Time (Oslo: Sunday 4 December, 2:30AM–4:30AM CET) and is available at: http://www.nordicnanovector.com/product-info/scientific-posters.

 

 

About Nordic Nanovector
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.

Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab (previously referred to as HH1), conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.

Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications.

Further information about the Company can be found at www.nordicnanovector.com

This information is subject to the disclose requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Strong recommendations for Blue Light Cystoscopy with Hexvix® in new French Guidelines

Oslo, Norway, November, 21 2016: Photocure ASA (OSE:PHO) announced today that new 2016 French National Guidelines for the management of Bladder Cancer includes its Blue Light Cystoscopy (BLC) with Hexvix®.  The new guidelines have been presented on November 17th, during Association of French Urologists (AFU) National Meeting, Paris, France published on line in Progres en urologie.

Please click here for an abstract of the guidelines.

The French guidelines recommend BLC with Hexvix® for the first bladder cancer resection (TURBT) in essentially all patients and for consecutive TURBT’s in the majority of patients. The recommendations are at an evidence level Grade B, demonstrating the strong clinical data supporting BLC with Hexvix®.

– The Association of French Urology National Bladder Cancer Guidelines for the management of patients with bladder cancer were last released in 2013.  One of the biggest differences since the last guideline is that it now includes the situations BLC with Hexvix® can be used to reduce the risk of recurrence of NMIBC. The strong recommendation for use of blue light cystoscopy with Hexvix® should result in contributing to increasing the level of urological care for the management of patients with bladder cancer in France, said  M. Roupret, during his presentation on the guidelines at the AFU meeting, Professor of Urology Pitié-Salpétrière – Hôpitaux de Paris University and one of the authors of the guidelines.

-The updated French National Guidelines recommending BLC with Hexvix® for such a wide range of patient types will result in BLC with Hexvix® being seen as standard of care. It is especially encouraging to see the strong recommendation for using BLC at the very critical first TURBT, which allows for the most correct staging and grading, which is crucial for the optimal follow-up and management of the patient. The recommendation for use in the first TURBT is also supported by Hexvix® cost effectiveness data developed for French conditions published in 20151, commented Kjetil Hestdal, MD, PhD, President and CEO, Photocure ASA.

In 2011, Photocure entered into a strategic collaboration with Ipsen to commercialize Hexvix®, its flagship product for the diagnosis and management of bladder cancer, worldwide except in the United States of America (USA) and the Nordic region. This technology represents a significant improvement for urologists and their patients. Ipsen is notably responsible for the commercialization of Hexvix® in France.

About Bladder Cancer

Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease2. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20123. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix® in Europe, excluding the Nordic region.

Please see here for further information on our commercial partners.

Photocure with good results

Oslo Cancer Cluster member Photocure ASA is a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology. They reported a revenue growth of 17 % to NOK 31.6 million in the third quarter of 2016 (Q3 2015: NOK 27.0) for the Hexvix/Cysview commercial franchise and a corresponding EBITDA of NOK 8.0 million.

Watch full presentation here.

 

About:
Photocure, the world leader in photodynamic technology, is a Norwegian based specialty pharmaceutical company. They develop and commercialize highly selective and effective solutions in several disease areas such as bladder cancer, HPV and precancerous lesions of the cervix and acne.

Photocure currently have one product on the market: Hexvix®/Cysview® (The brand name is Cysview in the US and Hexvix in the rest of the world).

The Photocure Technology® is uniquely selective, targeting affected areas without impact to non-affected areas. This allows for non-invasive procedures that improve quality of life.

For more information on Photocure.

Workshop Update: MyData and Blockchain-based innovation in the Digital Health Sector

Oslo Cancer Cluster hosted a workshop co-organized by Alpha Venturi on “MyData and Blockchain-based innovation in the digital Health sector” on 14 November 2016 @ Jónas Einarsson Auditorium. 

Stakeholders and companies from Norway, Finland, United Kingdom and Estonia have been involved in the brainstorming sessions on several aspects of digital health revolution. The Norwegian Health Directorate, Norwegian Centre for E-Health Research and University in Oulu/Digital Health Revolution from Norway and Finland introduced their respective country perspectives on digital healthcare and progress made relative to MyData.

Multinational biopharmaceutical company Amgen presented their views on the potential gains from such an approach. Alpha Venturi iterated the importance of Blockchain and Distributed Ledger Technologies as a potential game changer for Healthcare among other industries. Two foreign companies, Digi.me from UK and Guardtime from Estonia, have also been invited as external speakers to come and present their respective approach to enable access and sharing of personal health data, one of which based on Blockchain, and the pilots they are implementing respectively in Iceland and Estonia among others.

During this workshop, Alpha Venturi and Oslo Cancer Cluster, moderated the discussions on further perspectives on technologies like Blockchain for Health Care and Personalised Medicine. The first half of the workshop included informative presentations from the delegates, and the later half was focused on brainstorming discussions on potential collaborations.

Alpha Venturi will soon release a report from this workshop that will include short-term and long-term visions, recommendations of the activities and innovation projects in digital health space that can be initiated in Norway in partnership with other Nordic countries. You contact the CEO of Alpha Venturi, Wilfried Pimenta de Miranda at: wilfried@alpha-venturi.com

20161114_103338

Given below is the glimpse of the workshop agenda:

Start Activity Min.
8.45 Arrival of the first participants
9.10 Welcome, presentation of participants and background for the initiative

Oslo Cancer Cluster – Gupta Udatha

Alpha Venturi – Wilfried Pimenta de Miranda

20
9.30 Norway: Overview of the e-health situation and roadmap, examples

Norwegian Health Directorate – Erik Hedlund

10
9.40 Norway: Perspectives on ongoing e-health research and innovation related to MyData

Norwegian Centre for E-Health Research – Gustav Bellika

10
9.50 Finland: Overview of the e-health situation and roadmap, examples

Digital Health Revolution – Maritta Perälä-Heape

20
10.10 The changing data landscape and its impact on biopharma

Amgen- Jonathan Doogan

30
10.40 Pause 10
10.50 A person centric example, Health Iceland Living Lab

Digi.me – Julian Ranger and Andrew Carmody

30
11.20 Q&A 20
11.40 Lunch – Open discussions and networking 60
12.40 Introduction to Blockchain + Use cases in the Health sector

Alpha Venturi – Wilfried Pimenta de Miranda

30
13.10 Healthcare pilot for Estonia

Guardtime – Martin Ruubel

30
13.40 Q&A 20
14.20 Pause 10
14.30 How could a person centric approach be applied to a Norway/Finland healthcare sector 30
15.00 How to make personal data available to individuals 30
15.30 Pause 15
15.45 Building a common vision for the partnership, design principles, initial pilot thoughts 45
16.30 Agreement of next steps; creation of working group to follow up from the day 45
17.15 End & Networking until 17.45 30

For further information and discussions on Oslo Cancer Cluster’s digital health projects, please contact our Project Manager D.B.R.K. Gupta Udatha

D.B.R.K Gupta Udatha

Oslo Cancer Cluster and NCE Smart Energy Markets together with four European clusters in medicine and IT managed to land a prestigious Horizon 2020 EU project. The EU project will use innovative IT solutions to develop personalized cancer treatment. Allocated funds are 45 million NOK, of which 34 million NOK are earmarked for small and medium enterprises in the clusters. The EU project with the sounding name “Personalised Medicine Innovation through Digital Enterprise Solutions: PERMIDES”, will utilize digital tools and novel solutions from the IT sector  to support the development of new cancer treatment. This will be achieved by matching small and medium enterprises from the IT and the biopharma sector for joint innovation projects.

View PERMIDES page

Cancer Crosslinks 2017

Det er med stor glede vi inviterer onkologer, hematologer og forskere til det niende Cancer Crosslinks i vår egen Oslo Cancer Cluster Innovasjonspark.

Cancer Crosslinks er den årlige møteplassen for onkologer og hematologer. I 2017 går Cancer Crosslinks av stabelen 26. januar. Vi har delt inn dagen i tre faglige sesjoner som alle presenterer relevante, tverrfaglige temaer med stor klinisk relevans:

• Sesjon 1 “Cancer and Inflammation – new insights and their clinical impact”
• Sesjon 2 “Today’s cancer treatment: how individualized can it be?”
• Sesjon 3 “Classical endpoints vs. Real-world evidence – need to rethink?”

Vi er veldig stolt over å presentere internasjonale toppforelesere fra både Europa og USA som sammen med nasjonale eksperter vil gi innsikt i et fagfelt i rivende utvikling. Åpningssesjonen er med Professor Jerome Galon fra INSERM som blant annet står bak Immunoscore, som er ny metode for rutinemessig klinisk vurdering av prognosen til kreftpasienter. Vi ser også veldig fram til å høre Professor William G. Wierda fra MD Anderson snakke om hvor persontilpasset behandlingen av blodkreft kan gjøres i dag.

Vi håper møtet vil stimulere til tverrfaglig diskusjon og samarbeid “fra laboratorium til sykeseng”.
Presentasjonene vil foregå på engelsk.

Om du har problemer med å registrere deg elektronisk, scann inn svarslippen og send den på mail til jh@oslocancercluster.no. På grunn av stor interesse for Cancer Crosslinks, kan firmaer kun stille med to personer. Kaare Norum Auditorium har plass til 290 deltagere. Møtet vil også bli strømmet direkte.

  • Dersom du trenger fly eller togbillett, ta kontakt med vårt byrå Berg-Hansen på e-mail: bestilling@berg-hansen.no eller på telefonnummer: 08050. Vennligst oppgi kode “OCC”, belastes Oslo Cancer Cluster. Booking vil åpne torsdag 1. desember 2016.

Møtet arrangeres i samarbeid med Bristol-Myers Squibb og AbbVie Norge. Arrangementet er i samsvar med retningslinjene som er inngått mellom Legeforeningen og Legemiddelindustriforeningen. Denne invitasjonen er også sendt til administrasjonen og/eller avdelingsansvarlig, i henhold til sykehusets interne regler.

Targovax granted European Patent for ONCOS platform lead product, ONCOS-102

Oslo Cancr Cluster member Targovax has been granted European Patent for ONCOS platform lead product, ONCOS-102. This composition of matter patent protects Targovax’s lead product from its ONCOS platform, the oncolytic viral product ONCOS-102 and expires in 2029. A US patent covering ONCOS-102 was granted in May 2016.

Targovax’s proprietary ONCOS platform generates novel oncolytic viruses, an emerging class of biological therapy. ONCOS exclusively uses adenoviruses, which are engineered to be tumor targeted immune activators. The platform has the potential to generate therapies with superior efficacy and safety compared to the first approved oncolytic virus therapy, Imlygic, recently launched by Amgen.

In a previously reported Phase I trial ONCOS-102 treatment induced tumor-specific immune activation both at a systemic and lesional level in tumors of late stage cancer patients. The immune activation was associated with signals of clinical benefit. Targovax is currently initiating a number of Phase I/II clinical trials that are expected to readout in the next two years for the treatment of solid tumors such as melanoma, malignant pleural mesothelioma, ovarian cancer and prostate cancer.

ONCOS-102 has Orphan drug designation with the FDA and EMA in mesothelioma, ovarian cancer and soft tissue sarcoma.

Jon Amund Eriksen, Chief Technology Innovation Officer and Co-founder of Targovax said, “This European patent is an important addition to Targovax’s intellectual property portfolio covering our ONCOS platform and the engineered oncolytic viruses that arise from it. The patent further extends the protection of the lead product candidate from the platform, ONCOS-102, following the grant of a US patent for ONCOS-102 in May this year, both of which expire in 2029. The US and Europe are expected to be the largest markets for immuno-oncology products, the most rapidly growing segment for the development of innovative cancer treatments.”

The main characteristics of ONCOS-102 include:

  • The adenovirus knob 5 domain is replaced by a protein from a different adenovirus (serotype 3) to facilitate the specific entrance of ONCOS-102 into tumor cells
  • One of the genes affecting virus replication in the host cells is inactivated (D24 deletion). As a result, the virus cannot replicate in normal cells, but can do so in tumor cells
  • A gene coding for GM-CSF, a drug stimulating the immune response, inserted into the virus genome and expressed during the virus replication in the tumor cells

 

 

About Targovax

Arming the patient’s immune system to fight cancer

Targovax (OSE: TRVX) is a clinical stage company focused on developing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. The Company’s pipeline is created from two novel proprietary platforms, with three therapeutic candidates in clinical development covering six indications including melanoma, mesothelioma, ovarian cancer and resected pancreatic cancer. Targovax’s strategy is to bring products to market directly in those indications where it already has Orphan drug status and to partner with pharmaceutical companies in larger disease areas with significant commercial potential.

Size Matters: Need for Nordic Collaboration in Oncology Now

By Elisabeth Kirkeng Andersen, Communication Consultant Oslo Cancer Cluster
& Ketil Widerberg, General Manager Oslo Cancer Cluster

 

The biopharmaceutical industry is at a frenzy to develop innovative drugs for cancer. No wonder, when the market size is estimated to over 800 BNOK in 2020, the population world-wide is getting older and the incidence and prevalence of cancer is increasing. Hence – the need for better treatments is increasing exponentially. Both within immunotherapies and precision medicine there is a global race to develop the next generation treatments.

Nordic countries have a lot to contribute to here: Excellent research, very good public healthcare systems, national registries. To make most out of this they should team up and position the Nordics as a strong player contributing to the global value chain from bench to bedside. The Nordics should unite and act as a one-stop shop for clinical trials within oncology and work with the global companies to set up Nordic collaborations through the value chain from bench to bedside.

Cancer is a global burden. Every year 14 million people are diagnosed with cancer and 8,2 million people die of the disease each year. WHO expect a 70 % increase in diagnosis in the next decade. With rich, stable societies and the happiest and well-educated inhabitants the Nordics have a moral and ethical duty to contribute to solve the Worlds toughest challenges like disease and climate change.

The countries individually, Norway, Sweden, Finland, Denmark are way too small to get attention alone. We are not seen as interesting markets due to small population sizes. But if we team up it is different. Size matters in the war on cancer.

The Nordic countries have some unique features for oncology R&D, and the potential to be a global test bed for novel treatment. Factors we take for granted are unique features globally; great health registries, extensive bio banks, homogenous populations, trust in research, good and public health care systems and unique personal number each of us have from birth to death. The Nordic population may serve both as a predictor for novel biomarkers and diagnostic tests, and later as a real life verification for the effect of new treatments.

The need and benefits of Nordic collaboration within the oncology area is not a new idea. Several voices have raised this issue at numerous occasions. So far nothing more than words and political celebration speeches have come out of this. We have some initiatives going, like Nordic Life Science Days, collaborations between Oslo Cancer Cluster and the Medicon Valley Region and NordicNECT – but now is the time to step up on this. With the digital oncology revolution things will move fast. The Nordic countries need to get a much needed collaboration going. We are ready – let us move now.

Nordic Nanovector: Results from preclinical studies of Betalutin® in combination with rituximab in non-Hodgkin lymphoma model to be presented at ASH

Nordic Nanovector ASA (OSE: NANO) announces that a poster describing the therapeutic effect of combined treatment with Betalutin® (177Lu-satetraxetan-lilotomab) and rituximab in a preclinical model of non-Hodgkin lymphoma (NHL) (abstract 4189) will be presented at the 58th Annual American Society of Hematology (ASH) meeting (3-6 December 2016 in San Diego, CA, USA). These studies build on previously presented data showing that treatment with Betalutin® increased binding of rituximab to NHL cells and uptake of rituximab in NHL tumours. The combination treatment resulted in 90-100 % survival for 150 days after treatment, while each treatment alone gave from 10 to 40 % survival.

The ASH annual meeting is the premier event for scientific exchange in the field of hematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.

Poster details

Abstract 4189
Abstract title: Combination of 177lutetium-Satetraxetan-Lilotomab and Rituximab Results in Improved Therapeutic Effect in Preclinical Models of Non-Hodgkin Lymphoma
Authors: Repetto-Llamazares, AHV et al.
Session Name: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster III
Date/Time: Monday, 5 December 2016, 6:00 PM – 8:00 PM (PST)
Location: San Diego Convention Center, Hall GH
Link to abstract see here.

PERMIDES European Workshop @ 06th December 2016

PERMIDES EU Workshop in Oslo @ 06th December 2016 (12:00 -16:30 hrs)

The workshop starts with an introduction to PERMIDES, the innovation challenges to be addressed with this project and short presentations to inspire the subsequent workshop part.

Why join? You can benefit from innovation vouchers of up to EUR 60.000 to develop and implement novel IT based solutions for biopharmaceutical R&D challenges. By sharing your IT related needs and discussing potential solutions with potential partners you ensure that the innovation calls match your needs.

Questions? Connect to Gupta Udatha (gupta.udatha@oslocancercluster.no; 45534627) or Jutta Heix (jh@oslocancercluster.no; 94163089).

register

PERMIDES is a perfect opportunity for start-ups and SMEs that are involved in biopharma value chain, IT sector and emerging personalized medicine industries to team up with complementary partners and opt for the rich portfolio of services & direct funding PERMIDES provides.

How can you as a SME benefit from PERMIDES?

SMEs from the biopharmaceutical sector get access to relevant partners from the IT sector. The IT companies can develop and implement tailored digital solutions to improve business and product development processes. The costs incurred for this purpose by the IT partner will be covered by means of consulting, prototyping and customised solution vouchers totalling up to EUR 60,000. The biopharmaceutical company may also benefit from new products and applications developed by the IT company within the framework of the joint project.

SMEs from the IT sector get access to partners and new customers from the biopharmaceutical sector to apply and adapt their solutions to SMEs developing novel personalized medicine products. Innovation vouchers will cover their expenses, and the knowledge gained during these projects may create new products and business opportunities.

PCI Biotech with share issue in November

Oslo Cancer Cluster member PCI Biotech has initiated a process with the objective to carry out a share issue in the range of NOK 40-50 million by the end of November 2016. Two of the largest shareholders have pledged that they will at least follow up their pro-rata in the share issue. Fondsfinans is retained as advisors in this process.

 

The promising results from the Phase I part of the Phase I/II study of fimaChem in bile duct cancer and the recently granted orphan designation in EU have provided the Company with new exciting opportunities.  The Company has initiated processes to assess whether a well-designed pivotal Phase II study may provide market authorisation, which would significantly shorten the time to market for this orphan indication.

The proceeds from the contemplated share issue will allow the Company to complete regulatory interactions with European and US authorities, to determine the fastest way to market. The Phase I results have also furnished increased external interest, which will be assessed in relation to various financing and partnering alternatives for further development.

Establishing fimaVacc as a clinical asset in immunotherapy is a major milestone towards commercialisation and the proceeds will also be used to fund completion of the Phase I study. The initiated Phase I study in healthy volunteers is designed to show enhancement of the cellular immune responses important for therapeutic effect of vaccines, with expected read-out of results in the first half of 2017.

The strategy for the fimaNAc programme will continue to be an opportunistic approach, pursuing out-licensing opportunities.

 

About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform.  PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaChem programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

For more information visit: www.pcibiotech.com

 

Two new members i Oslo Cancer Cluster: NorGeno Tech & DNVGL

NorGeno Tech & DNVGL are now members of the Oslo Cancer Cluster. Please find more information on the new members below. 

About NorGeno Tech

NorGenoTech AS s a start-up company arose from the success of the EU FP6 project ‘COMICS’ in making improved high throughput methods for analysis of DNA damage and repair with the comet assay. Our main business is innovative products development, genotoxicity testing, expertise and consultancy.
We aim at becoming a leading comet technology player in Europe, carrying out laboratory services and providing modern equipment for high throughput diagnostic use and screening of chemicals, nutrients and drugs.
The founders of the company Gunnar Brunborg, Andrew Collins and Sergey Shaposhnikov are leading researchers in the field responsible for numerous innovations. Chris Brøvig is a business generalist involved in commercialisation of our inventions

ACTIVITIES WITHIN THE ONCOLOGY FIELD:
1. Genotoxicity testing of novel chemicals and drugs
2. Developing diagnostic tools for measuring DNA integrity in patients at the level of individual cells.

 

For more information see here.

About DNVGL

Driven by its purpose of safeguarding life, property and the environment, DNV GL enables organizations to advance the safety and sustainability of their business. We help businesses assure the performance of their organizations, products, people, facilities and supply chains through certification, accreditation, verification, assessment, and training services. Partnering with our customers, we build sustainable business performance and create stakeholder trust across all types of industries. Operating in more than 100 countries, our 14,000 professionals are dedicated to helping our customers make the world safer, smarter and greener.

We support healthcare organizations across the globe to apply a systems thinking to address risks and deliver high-quality, person centered care. Through our research programmes we are working to identify transformational changes needed in order to make healthcare safer and more sustainable. As a trusted partner, we work with healthcare providers, national and regional health authorities and key stakeholders around the world to improve healthcare quality and facilitate the provision of patient-centered, safe care. Building on more than 150 years of expertise in working with high risk industries to make them safer.

Building on our strong presence and recognition in Food & Beverage and Healthcare, we are expanding our scope and service offerings as a global assurance provider in the Life Sciences domain. More specifically to help organizations preserve health and provide food – two of the most fundamental human needs.

The world population is growing and life expectancy is increasing. Combined, this will put significant pressure on our food supply and healthcare systems. One response to this is the rapid advancement in supporting technologies and the harnessing of big data. But there are challenges related to quality, safety and integrity that must to be addressed. The involvement of independent assurance providers will be increasingly important.

 

For more information see here.

Kom med innspill til Helsedatautvalget

Ekspertutvalget for helsedata ønsker innspill fra Oslo Cancer Cluster sine medlemmer om hvordan man kan utnytte opplysninger i sentrale helseregistre, kvalitetsregistre, befolkningsbaserte helseundersøkelser og biobanker på en bedre måte.

Vi ønsker innspill til konkrete organisatoriske, tekniske og juridiske tiltak for å forbedre dagens system for tilgang til helsedata. Dette gjelder både til forskning og til tjenester/innovasjon.

Send dine innspill innen 15.11 til:

Les mer om ekspertutvalget her:

Nordic Nanovector and Heidelberg Pharma with new collaboration

Nordic Nanovector ASA (OSE: NANO), announces it has entered into a collaboration with Heidelberg Pharma GmbH, a subsidiary of biopharmaceutical company WILEX AG (FSE: WL6) specializing in the development of antibody-drug conjugates (ADCs), to develop novel ADCs for treating leukaemias. Leukaemias are orphan diseases with a significant unmet medical need, applicable indications representing a growing market worth over USD 5 billion by 2020.

This collaboration is part of Nordic Nanovector’s strategy to develop its pipeline of targeted therapies to include antibody products conjugated to anti-cancer compounds that are not radionuclides. Such conjugates are commonly referred to as ADCs.

Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer, commented -We are pleased to further expand our R&D activities into the ADC area with Heidelberg Pharma in this second strategic collaboration, following closely the collaboration announced recently with LegoChem. During the past year, we have made important steps to execute our strategy designed to build a pipeline of innovative antibody-radionuclide conjugates (ARCs) and ADCs that combine our expertise and platform with complementary technologies from expert partners. This strategy is aimed at creating multiple new targeted treatment options for patients who suffer a range of leukaemias and lymphomas.

Professor Dr Andreas Pahl, Head of Research & Development and member of the Management Board of WILEX and Heidelberg Pharma, commented -This project extends our portfolio of ADCs to further haematological cancers. Nordic Nanovector has an established chemistry, manufacturing, and controls (CMC) process for their antibody which will speed up processes and reduce the development costs of an ADC.

Ny rapport: Kreftkostnader i Norge

Kreftkostnader i Norge: Hvor ligger de største kostnadene? Hvilken kreftform er dyrest? Oslo Economics har utarbeidet en rapport om kostnadene ved kreft.

Kreft er på vei forbi hjerte- og karsykdom som den vanligste dødsårsaken i industrialiserte land. Samtidig lever stadig flere med en kreftsykdom. Oslo Economics har utarbeidet en analyse basert på registerdata, og ved hjelp av en referansegruppe med fremtredende krefteksperter og representanter fra Kreftregisteret, Oslo Cancer Cluster og Kreftforeningen, gjort et forsøk på å fylle kunnskapshullet.

Bristol-Myers Squibb har finansiert arbeidet, men har ikke vært involvert i design, analyser eller rapportering.

Doctor caring for elderly patient.

Help define gene panel

The Norwegian Research Council-financed project NCGC are joining forces with Norwegian Cancer Registry to establish a research platform for tumor-profiling in recruiting patients for clinical trials.

The objective is to make Norway an even more attractive location for the industry and to meet the industries specific needs. The first step in this work is to define a gene panel. In this connection the project team wants to get in contact with Oslo Cancer Cluster members who can give feedback on what targets should be included.

For more information, please contact:

More about NCGC here: cancergenomics.no 

New NRC grant: 45 MNOK to value creation in health care industry

The Research Council is planning to announce up to NOK 45 million in funding for projects that promote value creation in the healthcare industry. The call for proposals targets consortia comprised of companies and cooperating R&D groups and concerns new production technology within diverse areas such as pharmaceutical industry, diagnostics or medical technology.

The call is organised in two phases, where applicants first apply for funds to support mandatory feasibility studies. These are amongst other things intended to stimulate cooperation between parties with common needs.  The application deadline for feasibility studies is 23. November 2016. Find the call “NOK 5 million for feasibility studies of projects targeting production technology for the healthcare industry”.

The Research Council is organising an applicant’s workshop on 24. October from 10:00-13:00.

Nordic Nanovector and LegoChem Biosciences enter collaboration to develop novel antibody-drug conjugates

Nordic Nanovector ASA (OSE: NANO), is pleased to announce it has entered into a collaboration with LegoChem Biosciences, Inc. (“LegoChem”; KOSDAQ: 141080), a South Korea-based biopharmaceutical company, to develop novel CD37-targeting antibody-drug conjugates (ADCs) for the treatment of leukaemias.

Leukemias are orphan diseases with a significant unmet medical need, representing a growing market estimated to be worth over USD 5 billion by 2024. This collaboration supports Nordic Nanovector’s strategy to expand its pipeline of targeted therapies to include CD37-targeting antibody products conjugated to anti-cancer compounds that are not radionuclides. Such conjugates are commonly referred to as antibody-drug conjugates or ADCs.

Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer, commented -We are delighted to expand our R&D activities into the ADC area, a strategic and natural progression for us given our expertise in antibodies and the prevalence of the CD37 antigen on many tumour cell types. We believe that anti-CD37 ADCs will have clinical characteristics that are beneficial for treating a range of haematological malignancies. Our strategy to build a pipeline of innovative antibody-radionuclide conjugates (ARCs) and ADCs based on our expertise and platform, and in collaboration with expert partners such as LegoChem, is aimed at creating multiple new product opportunities bringing new targeted treatments to patients.

-We are very excited to enter into this collaboration agreement to develop CD37-targeting ADCs with Nordic Nanovector, which has expertise with anti-CD37 antibodies and experience of advancing candidates into clinical research, said Jeiwook Chae, Chief Business Development Officer of LegoChem. -We strongly believe that our proprietary conjugation platform addresses significant unmet needs of current ADC technologies. With Nordic Nanovector’s deep expertise in antibodies and commitment to develop novel therapeutics, we are confident that we will further enrich the pipeline of next-generation ADCs and achieve our goals of advancing the landscape of cancer treatment and providing new clinical options for cancer patients.

DNB Health Care Prize and Nordic Health Care Conference

December 15th is the date for the annual DNB HealthCare Conference. Be sure to apply for both the Health Care prize and to be a part of the Venture Session. You should find all information needed below.

Deadline for applying for the DNB Health Care Prize  and for pitching at the Venture Session is October 26th.

Great interest in R&D Precision Cancer Medicine meeting

Over 50 people turned up for our R&D Network meeting on Precision Cancer Medicin at Stavanger University Hospital yesterday. The meeting was a collaboration beetween Oslo Cancer Cluster and Stavanger University Hospital(SUS) and was hosted by SUS.

The speaker list included Jon Arne Søreide from the Gastrointestinal Surgical Research Group, Bjørnar Gilje from the Reseach Group for Oncology and Medical Physics and Emiel Janssen from the research group at the Department of Pathology.

We were also fortunate to have Åslaug Helland from Oslo University Hospital (OUS) with us to give us some clinical perspectives. Helland is the group leader for the Research Group for Translation Studies on Solid Tumours. More info on Hellands group here

Representing the biotech side, we had Kjetil Hestdal from PhotoCure showing examples of the opportunities photodynamic technology give patients with bladder cancer.

Aslaug Aamodt Muggerud from MSD talked about biomarkers and how precision medicine is different from “traditional treatment”.

Great collaboration between IBM:Watson and Oslo Cancer Cluster

Since IBM became a member of Oslo Cancer Cluster in June this year, there has been a tremendous interest in their software Watson who is about to learn Norwegian from students at Ullern High School.

The role of cognitive technology in cancer diagnostics has received attention both in national and international media. You can find some of the news stories on Watsons role in the fight against cancer below:

Repeat use of Blue Light Cystoscopy with Hexvix®/Cysview® shows excellent tolerability

Oslo, Norway, September 28th, 2016: Photocure ASA announced today that a study published on-line in the peer reviewed Journal of Urology, shows that there is no significant statistical difference in the frequency or grade of adverse events in patients having one Blue Light Cystoscopy with Cysview® (BLCC) versus repeat BLCC procedures. Here is a link to the abstract.

 

This retrospective review of 180 patients who underwent 269 BLCC procedures at two institutions in the United States compared the incidence and grade of Adverse Events (AE), after initial and subsequent BLCC procedures.  35% of the patients underwent BLCC more than once, including 2 patients who underwent BLCC five times.

-We found no statistically significant difference in AEs between those patients undergoing 1st versus two or more repeat procedures.  None of the AEs were classified as probably or definitely related to BLC with Cysview.  These results, along with the excellent clinical efficacy seen with BLC with Cysview, give those who manage Bladder Cancer patient’s further reassurance in using BLCC repeatedly, said Dr. Badrinath Konety, Professor and Chair Dept of Urology, University of Minnesota, Associate Director for Clinical Affairs Masonic Cancer Center.

– It is very encouraging to see more data being generated from the use of BLC with Cysview in the U.S. These data are supportive of the current clinical practice in Europe, and demonstrate that using BLC with Cysview repeatedly in the same patient has no safety concerns”, commented Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

 

About Bladder Cancer

Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20122. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

 

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an optical imaging agent in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.  Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

International press event created attention all over Europe

Early September Oslo Cancer Cluster hosted an international press event with our member Abbvie. Over 20 journalists from all over Europe came to the Oslo Cancer Cluster Incubator and Innovatiion Park to learn more about the latest technological and scientific developments within cancer research.

 

The journalists attended a full day meeting at the Innovation Park which included a lab session with Ullern High School students and researchers at the Cell Therapy Lab, whom showed them how cells are programmed to kill cancer cells. Gunnar Sæter, Head of the Cancer Institute, introduced the journalists to the topic of precision medicine in oncology with Oslo Cancer Cluster members SAS and IBM demonstrating the latest developments within data collection and analysis. Giske Ursin, Director of  Cancer Registry Norway, explained how the unique health data we have in Norway provides a large unused potential within oncology.

 

The journalist also got to meet Deborah Simms, journalist and cancer survivor and her doctor, John Gribben from the Barts Cancer Institute. They explained the role of collaboration in the diagnostics and treatment of patients with unmet need.

 

Successful Nordic Life Science Days 2016

The Nordic Life Science Days 2016 was a great success at many levels. For the first time the Norwegian life science actors invited to a joint meeting to promote a closer collaboration with the Swedish life science milieu at an even t at the Norwegian Embassy in Stockholm. Oslo Cancer Cluster was co-hosting the Nordic Life Science conference this year, and we hosted three super-sessions on oncology which set the scene for the future of oncology treatment.

 

Below you may find a summary of the coverage of our joint activities with UIO:Life Science and LMI at the Nordic Life Science Days, only in Norwegian. We will also like to stress our gratitude towards both Ambassador Kai Eide and his staff at the Noorwegian Embassy in Stockholm and Director for Innovation Anne Kjertsi Fahlvik at the Norwegian Research Council for sponsoring and great collaboration.

 

Kronikk i Dagens medisin 13. september: Livsvitenskap stort potensial for verdiskaping

Med et nordisk samarbeid for klinisk utprøving kan vi stå sterkere i konkurransen om å tiltrekke oss aktører som vil gjennomføre kliniske studier. Dette kan gi nordiske pasienter tilgang til innovativ behandling.

#noswelife

Aktivitet på Twitter fra nettverkskvelden kan på ses på hashtagen #noswelife

https://twitter.com/search?q=%23noswelife&src=typd

Standbesøk

Fra ambassadørens besøk på standen sammen med medsponsor Forskningsrådet
https://twitter.com/forskningsradet/status/776023988204101633

Omtaler på lmi.no

Nordic Life Science Days er i gang i Stockholm

LMI står på stand med flere andre aktører for å promotere Norge og norsk livsvitenskap.

Trenger Norge en egen koordinator for livsvitenskap?

Det var et av temaene da ambassaden inviterte til nettverkskveld i går.

Omtaler på uio.no/livsvitenskap

Norsk-svensk nettverkskveld og Nordic Life Science Days

http://www.uio.no/forskning/satsinger/livsvitenskap/aktuelt/aktuelle-saker/2016/norsk-svensk-nettverkskveld-og-nordic-life-science.html

Også sendt med nyhetsbrev til over 1000 abonnenter

http://www.uio.no/forskning/satsinger/livsvitenskap/aktuelt/nyhetsbrev/2016/september.html

Omtaler på norge.se

Vellykket norsk-svensk dialog-kveld om Life Science samarbeid. Norsk-svensk «Helseinnovatørskole» lansert. http://www.norge.se/News_and_events/Nyheter-om-politikk-og-okonomi/Vellykket-norsk-svensk-dialog-kveld-om-Life-Science-samarbeid-Norsk-svensk-Helseinnovatorskole-lansert-/#.V-kZnfmLRaQ

Nordic Life Science Days og norsk-svensk nettverkskveld

  1. og 15. september arrangeres Nordic Life Science Days i Stockholm, Nordens største konferanse for den globale livsvitenskapsindustrien. I tilknytning til konferansen arrangerer Norges ambassade en svensk-norsk dialog og nettverkskveld.

http://www.uio.no/forskning/satsinger/livsvitenskap/aktuelt/nyhetsbrev/2016/september.html

 

New BGB324 study points to novel mechanism to enhance immunotherapy efficacy

Bergen, Norway, September 25, 2016 – Leading oncology biopharmaceutical company BerGenBio AS, today released important new preclinical study data on its first-in-class AXL inhibitor, BGB324. The study showed AXL to be a key factor in tumour resistance to the emerging class of new immune checkpoint inhibitors that can be targeted through combination therapy with BGB324. The study data was presented in a poster today at CRI-CIMT-EATI-AACR – The 2nd International Cancer Immunotherapy Conference, in New York.

 

The new study evaluated whether BGB324 used in combination with immune checkpoint inhibitors (anti-CTLA-4 and anti-PD-1) in mouse carcinoma models enhanced the effect of immune checkpoint blockade in aggressive adenocarcinomas displaying limited immunogenicity. BGB324 is a highly selective small molecule inhibitor of the AXL receptor tyrosine kinase. An important regulator of the tumour cell plasticity related to EMT (Epithelial-to-Mesenchymal Transition), AXL signalling is also a key suppressor of the innate anti-tumour immune response. Thus Axl contributes uniquely to both tumour intrinsic and extrinsic mechanisms that suppress anti-tumour immunity. The new study shows that AXL was induced in tumours by immune checkpoint inhibitor treatment and postulated that this could limit their efficacy.

 

The poster was entitled “BGB324, a selective small molecule inhibitor of AXL receptor tyrosine kinase, enhances immune checkpoint inhibitor efficacy”, and presented in Poster Session B on September 26. In the study, immune therapy with anti-PD-1/anti-PD-L1 or anti-CTLA-4/anti-PD-1 increased AXL and EMT-marker expression in the murine lung cancer (Lewis lung, LL2) and mammary adenocarcinoma (4T1) syngeneic models, and correlated with a lack of response to immune checkpoint therapy. However, combination treatment with BGB324 significantly enhanced durable responsiveness to anti-PD-1/anti-PD-L1 or anti-CTLA-4/anti-PD-1 treatment  in mice bearing established LL2 or 4T1 tumors. BGB324 in combination with anti-PD1/PDL1 increases the number of tumor infiltrating cytotoxic T-lymphocytes, natural killer (NK) and NKT cells and decreases levels of myeloid derived suppressor cells (mMDSCs) in the Lewis Lung cancer model.

 

Studies with human non-small cell lung cancer (NSCLC) indicated that BGB324 blocks a critical protective mechanism used by cancer cells to avoid destruction by effector immune cells. Targeting this mechanism resulted in a highly immunogenic cell death and increased cytotoxicity by human NK cells. Further, BGB324 blocked tumour suppressive (M2) polarization of primary human macrophages in vitro.  BGB324 treatment in combination with PD-1 pathway inhibition reduced mouse lung tumor expression of the key macrophage stimulating cytokine CSF-1, emphasizing how Axl targeting abrogates anti-tumour immune suppressive macrophage action.

 

BGB324 is the only selective AXL inhibitor currently in clinical development. Phase Ib clinical trials are underway as single agent and in combination with standard of care drug (cytarabine) in acute myeloid leukaemia (AML), and in combination with erlotinib in non-small cell lung cancer (NSCLC).

Richard Godfrey, Chief Executive Officer of BerGenBio, commented -We believe this strong new preclinical data clearly demonstrates the rationale for combining BGB324 with immune checkpoint inhibitors to treat aggressive cancers. This study shows that these inhibitors actually increase AXL expression that supports immune evasion.  Treatment with BGB2324 counters this, increasing tumor immunogenicity and promoting the anti-tumour response. In addition to the ongoing development of BGB324 in AML and NSCLC, this data suggests that BGB324 could also be used in combination with cancer immunotherapeutic agents to enhance their efficiency.

 

 

About BGB324

BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition (EMT), which is a key driver in immune evasion, drug-resistance and metastasis.

About BerGenBio AS

BerGenBio AS is a clinical stage biopharmaceutical company focused on developing first-in-class drugs for aggressive cancers. The company is a world leader in understanding the biology of epithelial-mesenchymal transition (EMT), a widely recognised key pathway in immune evasion, acquired cancer drug-resistance and metastasis. BerGenBio AS is founded on proprietary platform technology, CellSelect™, to identify and validate novel drug targets and biomarkers. The company has progressed its lead drug candidate BGB324, an EMT inhibitor, into clinical trials in AML and NSCLC, while pursuing the pre-clinical development of additional compounds and proprietary EMT drug targets.

For more information see here.

Joe Biden is looking to Norway

Vicepresident Joe Biden used Norway as an example when he spoke at the Social Good Summit this week. Biden was appointed by Barack Obama to lead the “Cancer Moonshot” project. The project aims to make a decade’s worth of advances in cancer prevention, diagnosis, treatment, and care in just 5 years.  

 

The collaboration between Lawrence Livermore National Laboratory and Norwegian Cancer Registry is a central part of this strategy. The collaboration, facilitated by Oslo Cancer Cluster, is aiming to optimalize cervical cancer screening by using machine learning and neural networks to look at historical data.

 

 

 

 

Two new members in Oslo Cancer Cluster: Artemida Pharma and Arctic Pharma

Artemida Pharma and Arctic Pharma are now members of the Oslo Cancer Cluster. Please find more information on the new members below. Arctic Pharma is also part of the Oslo Cancer Cluster Incubator. 

 

About Artemida Pharma

Artemida Pharma is a well-established drug development consultancy whose highly experienced scientists represent multiple disciplines with a specialism in oncology. Artemida Pharma offers optimised strategic drug development from product concept to clinical proof of concept.

Main Indications

  • Oncology
  • Autoimmune/Anti-inflammatory Diseases
  • Anti-infectives
  • Cardiovascular (HT, Stroke, CHF, Vascular Occlusion)

Products

  • Antibodies and Therapeutic Proteins
  • Small Molecules
  • Peptides
  • Oligonucleotides

Artemida Pharma has been intimately involved over the past 20 years in providing development planning for oncology indications in both solid and haematological tumours. Their involvement commences with mode of action or potential target elucidation and indication-seeking to optimise the development pathway and to assist companies in moving through to proof of concept. Identification of the most appropriate development as well as regulatory path includes support with regulatory interactions and document authoring along with product support from technical, scientific and medical representation through to project management. Artemida Pharma have supported companies ranging from a large multinational peri-approval programme to micro-start-ups from academia. More recently they were working with several companies in the immune-oncology field in solid tumours, photodynamic therapies as well as with targeted therapies in haematological indications.

For more information see here.

 

About Arctic Pharma

Arctic Pharma AS is a small start-up company committed to developing innovative anti-cancer drugs by exploiting the “sweet tooth” of cancer cells and their peculiar metabolic features. We directly target key enzymes that are upregulated in cancer cell metabolism with inhibitors designed at Arctic Pharma. This will enable us to develop new pharmaceuticals to combat cancer that exhibit fewer side effects.

Arctic Pharma AS is a privately held company founded in 2012 by shareholders and employees of Spermatech AS. Our mission is to make Arctic Pharma a leader in designing cancer therapies that are environmentally friendly and have few side effects.

We have performed a modern drug discovery project searching for potent and novel inhibitors of the Warburg effect. In this work, we have screened more than 300,000 drug-like compounds in biochemical and biological assayes. This has resulted in approximately 100 promising hit compounds. Some advanced hits have been generated by medicinal chemistry. Pilot studies have demonstrated that several of our compounds are potent inhibitors of cancer cell growth. Since we target an underlying mechanism of malignancy, the innovated drug will have the potential of curing various types of cancers and at different stages of malignancy.

Their mission is to make Arctic Pharma a leader in cancer therapies that are environmentally friendly and have few side effects.

For more information see here.

 

 

 

Results from a large German study show that BLC with Hexvix® significantly improves detection of NMIBC

Photocure ASA announced today that data from the OPTIC III study:  Optimized photodynamic diagnosis for transurethral resection of the bladder tumor (TURBT) in German clinical practice, is now available online in the World Journal of Urology.

For more information see here. 

The results of this large 30 center study demonstrate that Blue Light Cystoscopy (BLC) with Hexvix significantly improves the detection of NMIBC versus the standard procedure of white light (WLC) alone in routine clinical practice in Germany.

– This multicenter, prospective, non-interventional 403 patient study from 30 German inpatient surgical centers is an unprecedented assessment of the additional detection of cancer lesions with BLC with Hexvix versus WLC alone.  Data from randomized clinical studies clearly demonstrates the benefit of BLC with Hexvix, especially in high risk cases. It now is encouraging to see the growing body of evidence supporting such benefit in routine clinical practice in line with current guideline recommendations, said Professor Dr. Maximillian Burger, Chair of Urology of the University of Regensburg, Germany.

– We are excited to see the addition of more real world data which continues to support the advantages of BLC with Hexvix.  These real life data demonstrating the benefit of Hexvix/Cysview in a routine clinical setting highlight the significant value of Hexvix/Cysview, support the strong data delivered in randomized clinical trials and the inclusion in significant guidelines. As more urologists are exposed to the continued flow of data with Hexvix, we will continue to see even more patients having access to its substantive benefits, commented Kjetil Hestdal, MD, PhD, President and CEO, Photocure ASA.

Ipsen Pharma is strategic partner for Hexvix® in Europe excluding the Nordic region, and accountable for marketing in Germany. The OPTIC study was sponsored by Ipsen Pharma.

About Bladder Cancer
Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20122. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada.  Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.

For further information on our commercial partners see here.

PCI Biotech: Independent evaluation confirms early promising signs of efficacy in the phase I/II bile duct cancer study

Oslo, 6 September 2016 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company reported today an update on the phase I/II study in inoperable bile duct cancer patients.

The phase I part of the study has been completed with good tolerability and promising early signs of efficacy. The independent evaluation of the radiology data at six months from patients treated in cohort III and the expanded cohort IV is now finalised. A total of seven patients had radiologically evaluable cancer and four of these had objective tumour response, of which two were complete responses.

The central external evaluation was commissioned to ensure independent expert verification of the results reported by the various European sites. The evaluation was performed by two independent radiology experts from the US and in accordance with the generally accepted response evaluation criteria in solid tumours (RECIST).

Per Walday, CEO of PCI Biotech, said -These early promising signs of efficacy, verified by independent radiology experts, represents an important milestone for the bile duct cancer programme. The patient numbers in our study are small, but the results suggest a several fold increase in objective tumour response rate compared to the landmark study for the current standard treatment, the so called ABC02 study, published in the New England Journal of Medicine in 2010. Local tumour response in the bile duct is especially important in this cancer, to maintain biliary drainage. The fimaChemtreatment boosts the chemotherapy effect locally in the bile duct, thereby directly targeting the area of most importance to treat. We now have a programme with orphan designation and promising early signs of efficacy in an area with high-unmet medical need. We look forward to take this programme to the next step of development towards the awaiting patients.

About bile duct cancer (cholangiocarcinoma)  
The bile duct drains bile from the liver into the small intestine. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death. Currently, surgery is the only curative option for these patients; yet the majority of the tumours are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. The combination of gemcitabine and cisplatin has shown promising results and has become standard treatment in some regions, but there is still a need for better treatments to increase overall survival and quality of life.

About PCI Biotech   
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform.  PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaChem programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products.  fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies.  fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

Lilotomab pre-dosing of NHL patients before Betalutin® therapy lowers haematological toxicity

Oslo, Norway, 5 September 2016

Nordic Nanovector ASA (OSE: NANO) announces that two papers recently published in The Journal of Nuclear Medicine have shown that pre-dosing with the anti-CD37 antibody lilotomab (previously referred to as HH1), prior to injection with Betalutin® (177Lu-lilotomab) reduces haematological toxicity without adversely impacting the amount of radiation absorbed by the tumour. Betalutin® is a novel anti-CD37 antibody-radionuclide-conjugate (ARC) currently in Phase 1/2a. Two pre-dosing regimens have been investigated, one with 40 mg unlabeled lilotomab antibody (Arm 1) and one without (Arm 2). Data from eight patients were included in both papers.

The first paper 1) looked at the risk that pre-dosing with lilotomab could block the CD37 antigen on tumour tissues adversely impacting the amount of radiation absorbed by the tumour. The research shows that there was no difference in the tumour absorbed dose for patients in Arm 1 and Arm 2. The reduced distribution volume and clearance in Arm 1 might explain this finding as it implies that the concentration of Betalutin® in the blood was higher for Arm 1 patients than for Arm 2 patients, therefore increasing concentration counteracts any eventual blocking of CD37 on tumour tissue.

The second paper 2) looked at the radiation exposure of the red bone marrow (RM) which is often the primary organ at risk in radioimmunotherapy. Irradiation of the marrow may induce short and long-term haematological toxicity.

Researchers found that the RM radiation doses were significantly higher in the patients who did not receive pre-dosing. This difference indicates that pre-dosing with lilotomab has a protective effect for RM, most likely thanks to the unlabeled antibody, which blocks the binding to CD37 in the RM.

Jostein Dahle, Nordic Nanovector CSO, commented -The results outlined in these two publications further support our hypothesis that pre-dosing with lilotomab provides a protective effect on healthy tissues when used prior to Betalutin® treatment and importantly that pre-dosing does not adversely impact the radiation absorbed by the tumor. These findings also support our development strategy for Betalutin®, where we are looking at different pre-dosing regimens in order to identify the optimal dose regimen of this novel antibody-radionuclide-conjugate to take into later stage clinical trials.

The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.

1) J Nucl Med Published August 4, 2016 as doi:10.2967/jnumed.116.173922
2) J Nucl Med Published September 1, 2016 as doi:10.2967/jnumed.116.180471

PCI Biotech and BioNTech initiates preclinical research collaboration

Oslo Cancer Cluster member PCI Biotech is a cancer focused biopharmaceutical company. They have initiated a preclinical agreement with BioNTech AG, which is a fully integrated biotechnology company developing individualized cancer immunotherapies.

 

The partnership is governed by a preclinical research collaboration agreement. In brief, the preclinical research collaboration will evaluate technology compatibility and synergy based on in vivo studies performed by the University of Zurich. The companies will evaluate results achieved from this research collaboration and then explore the potential for a further partnership. PCI Biotech has already a collaboration agreement with the University of Zurich and the research is funded through the existing agreement.

Per Walday, CEO of PCI Biotech, said: “I’m very pleased to announce another research agreement in the field of nucleic acid therapeutics. We believe that the PCI technology has the potential to play a role in the realisation of several new therapeutic modalities. We look forward to explore synergies with BioNTech’s pioneering disruptive technologies.“

 

About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform.  PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaChem programme consists of a clinical Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products.  fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies.  fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.
About BioNTech AG
BioNTech AG is an immunotherapy leader with bench-to-market capabilities, developing truly personalized, well tolerated and potent treatments for cancer and other diseases. Established by clinicians and scientists the Group is pioneering disruptive technologies ranging from individualized mRNA based medicines through innovative Chimeric Antigen Receptors /T-cell Receptor-based products and novel antibody checkpoint immunomodulators. BioNTech’s clinical programs are supported by an in-house molecular diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE and IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held, with Strüngmann Family Office as a majority shareholder, having closed the largest initial financing in the European biopharma sector’s history. Information about BioNTech is available at www.biontech.de.

 

PERMIDES project going forward with project manager hired

Oslo Cancer Cluster and NCE Smart Energy Markets together with four European clusters in medicine and IT managed to land a prestigious Horizon 2020 EU project this spring. The official kick-off for the project is September 7th to 8th in Karlsrue and project manager Gupta Udatha is hired to work in both Oslo and Halden to implement the project from Norwegian side.

 

Project manager Gupta Udatha He works at both the Norwegian Centres of Expertise located in Eastern Norway, i.e. Oslo Cancer Cluster and Smart Innovation Østfold. The PERMIDES project aims at establishing fruitful collaborations between the bio-pharmaceutical and IT sectors in the European region to advance the field of personalised medicine through the development of novel digital solutions with cancer as the model disease.

– Gupta has an amazing background from bioinformatics and big data analytics of biopharmaceutical data. We are confident he is going to drive this project forward in a satisfactory way, says Ketil Widerberg, CEO Oslo Cancer Cluster and Dieter Hirdes, F & I Coordinator Smart Innovation Østfold company as a leader NCE Smart Cluster in a joint comment.

The PERMIDES project will start 1 September and with a kick-off meeting in Karlsruhe 7th to 8th September.

 

 

Photocure hosts bladder cancer key opinion leader breakfast in New York City

Oslo, Norway, August 29, 2016, Photocure ASA hosted on August 25 an educational event in New York aimed at institutional investors and analysts, which focused on the treatment of bladder cancer.
At the event, key opinion leaders (KOLs) from the New York Presbyterian / Columbia Hospital, University of Chicago, University of Texas Southwestern Medical Center presented details on the diagnosis, treatment and management of bladder cancer; gave an update on the new American Urological Association / Society of Urologic Oncology guidelines, and addressed progress being made in the evolving field of genomics in guiding treatment and the future direction of bladder cancer management. During the event, physicians also highlighted the role of Photocure’s Blue Light Cystoscopy with Cysview®, in the detection and management of bladder cancer.

Kjetil Hestdal, President and CEO of Photocure commented, -We would like to thank participants for joining us at this informative event. We are encouraged by the progress we are seeing with Blue Light Cystoscopy with Cysview in the US marketplace and are committed to making this important product accessible to patients and physicians in this market.

The event was recorded and presentations can be found at:

 

Cancer of the Urinary Bladder
Dr. Gary Steinberg; Bruce & Beth White Family Professor of Surgery & Vice Chairman of Urology & Director Urologic Oncology, University of Chicago

Genomic Landscape of Bladder Cancer
Dr. Yair Lotan; Professor, Chief Urologic Oncology, Holder of the Helen J. & Robert Strauss Professorship, Univ. of Texas Southwestern Medical Center

Risk Stratification and Guidelines for Management of NMIBC
Dr. James McKiernan; John K. Lattimer Professor & Chairman Dept. of Urology, College of Surgeons & Urologist-in-Chief at NY Presbyterian Columbia Hospital & Vice Chair, AUA Guidelines Committee

About Bladder Cancer
Bladder cancer is the fifth most common cancer in men with more than 330,000 new cases annually and more than 130,000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20122. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.  Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

Ultimovacs satser sterkt på videre utprøving av lovende kreftvaksine

Kreftvaksineselskapet Ultimovacs AS henter NOK 75 millioner til finansiering av videre kliniske studier. Selskapet har gjennomført tre vellykkede fase I-studier for sin terapeutiske vaksine mot kreft. Over 50 kreftpasienter har deltatt i studiene. Studiene viser at mer enn 80% av pasientene får aktivert sitt immunsystem som følge av denne behandlingen.

Bilde: Administrerende direktør Øyvind Kongstun Arnesen, kreditering: Charlotte Sverdrup

Eksisterende aksjonærer og ansatte bidrar med NOK 55 millioner, mens Watrium AS skyter inn NOK 15 millioner av totalt MNOK 20 millioner fra nye aksjonærer.
«Studiene er relativt små, men gir klare signaler om at vaksinen kan gi positive kliniske effekter for pasientene», sier Øyvind Kongstun Arnesen som er administrerende direktør i Ultimovacs.

I de nye kliniske studiene som skal igangsettes ønsker selskapet å dokumentere at vaksinen kan gi betydelig behandlingsgevinst for kreftpasienter.

Ultimovacs er ett av flere norske selskaper med tilknytning til Oslo Cancer Cluster som ligger langt fremme i utviklingen av nye behandlingsformer mot kreft basert på immunterapi. Norge ligger langt fremme innenfor immunterapi og har et godt grunnlag for å utvikle en næring med internasjonalt potensial. «Vår teknologi, som har sitt utspring fra Radiumhospitalet, kan vise seg å gi et betydelig bidrag i utviklingen av nye metoder for kreftbehandling», sier Øyvind Kongstun Arnesen. Vaksinen vil over de neste 2-3 årene testes ut på mer enn 250 pasienter i flere land.

Ultimovacs har over det siste året styrket sin organisasjon vesentlig og har nå 10 ansatte.
«Vi har et svært kompetent team på plass for videre utprøving og kommersialisering av vaksinen internasjonalt», fortsetter Øyvind Kongstun Arnesen.

Ultimovacs har solide finansielle eiere som Gjelsten Holding AS, Canica AS, Sundt AS og nå kommer også Watrium AS inn som ny aksjonær. I den forbindelse vil Kristin Wilhelmsen fra Watrium tre inn i styret i Ultimovacs. Inven2 AS og Radiumhospitalets Forskningsstiftelse er også betydelige eiere i Ultimovacs.

Ultimovacs er verdsatt til NOK 475 millioner før innhenting av ny kapital. DNB Markets og Arctic Securities har bistått selskapet som finansielle rådgivere og tilretteleggere av transaksjonen.
«Vi er meget tilfreds med å ha en bred sammensetning av kapitalsterke, langsiktige og kompetente eiere som bidrar aktivt til den videre utviklingen av selskapet», sier styreleder Ketil Fjerdingen.

__________________________________________________________________________________

Ultimovacs AS er et norsk selskap som arbeider med å utvikle immunterapi mot kreft i form av en universell, terapeutisk kreftvaksine.  I dag har selskapet 10 ansatte som holder til i Oslo Cancer Cluster Innovasjonspark ved Radiumhospitalet. Selskapet er i ferd med å avslutte sitt fase I-program hvor man har fått data om sikkerhet, valg av dose og vaksinens evne til å aktivere immunsystemet. Med støtte i disse dataene går selskapet nå videre til fase II for å undersøke om vaksinen har positiv effekt på kreftsykdom. Ultimovacs største eiere er Gjelsten Holding AS, Inven2, Radiumhospitalets Forskningsstiftelse, Langøya Invest, Canica AS og Sundt AS.

Nordic Nanovector completes recruitment of the first cohorts

Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces that the first cohorts of both Arm 3 and 4 of the expanded Lymrit 37-01 clinical study with Betalutin® have been completed. Betalutin® is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin lymphoma (NHL), including Follicular Lymphoma (FL).
Arm 3 is investigating the safety and efficacy of Betalutin® in relapsed FL patients pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a few hours prior to the administration of 15 MBq/kg Betalutin®. Arm 4 is investigating the safety and efficacy of Betalutin® in relapsed FL patients pre-dosed with high-dose unconjugated “cold” lilotomab (previously referred to as HH1) anti-CD37 antibody on Day 0, a few hours prior to the administration of 15 MBq/kg Betalutin®.
Luigi Costa, Nordic Nanovector CEO, commented -We are pleased to have completed the first cohorts of both Arm 3 and Arm 4 of the expanded Lymrit 37-01 study. These arms are designed to investigate if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve even better efficacy and an even more compelling product profile. The role of pre-dosing is to potentially ensure better control of haematological side effects and more specific tumour targeting with Betalutin®.
A potential decision to increase the dose of Betalutin® to 17.5 MBq/kg or 20 MBq/kg in one or the other arm can be made based on the evaluation of the safety and efficacy data observed in these first 3 patients of both arm.
The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.

Photocure with exciting news: FDA-approval of new packaging for bladder cancer product

New Cysview kit has an improved design providing healthcare professionals with an improved, simplified, and easy-to-use product.

 

Oslo Cancer Cluster member Photocure recently received the positive news that the U.S. Food & Drug Administration (FDA) has granted approval for an improved and more user-friendly packaging for Cysview. Regulatory approval in EU was granted in July 2016.

Diluent for Cysview is used to reconstitute the Cysview powder resulting in the Cysview solution. The diluent that is used to reconstitute the Cysview powder will now be provided in a prefilled syringe and in a needle free kit.

“This improvement is aligned with our mission to provide bladder cancer patients with access to treatments that improve their lives. The new Cysview kit will simplify the clinical use of Cysview both in the use of Blue Light Cystoscopy with Cysview during bladder cancer resection as well as the future launch of Cysview in the outpatient surveillance setting”, says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

 

 

About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.  Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

 

About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, and skin conditions. Our aim is to provide solutions, which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

 

About Bladder Cancer
Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence.

A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 2012. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

PCI Biotech with positive opinion for Orphan Drug Designation

Oslo Cancer Cluster member PCI Biotech has received positive opinion from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) for its lead product candidate, fimaporfin. Firmaprofin is intended to be used in the treatment of bile duct cancer,  cholangiocarcinoma.

Fimaporfin (AmphinexTM) is in clinical phase I/II development for inoperable bile duct cancer, a disease without approved medicinal treatment and a high need of better local treatment alternatives.

 

About bile duct cancer (cholangiocarcinoma)  
The bile duct drains bile from the liver into the small intestine. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death. Currently, surgery is the only curative option for these patients; yet the majority of the tumors are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. The combination of gemcitabine and cisplatin has shown promising results and has become standard treatment in some regions, but there is still a need for better treatments to increase overall survival and quality of life.

 

About PCI Biotech         
PCI Biotech is a cancer focused biopharmaceutical company headquartered in Norway and listed on the Oslo Stock Exchange (Axess). The company is developing therapeutic products based on its proprietary photochemical internalisation (PCI) technology. The PCI technology works by inducing triggered endosomal release and may be used to unlock the true potential of a wide array of therapeutic modalities, such as small molecules, vaccines and nucleic acids.  The company has a clinical Phase I/II program in bile duct cancer.

The company is also developing PCI as a vaccination technology. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines. The PCI technology is also very well suited for intracellular delivery of nucleic acids, such as RNA therapeutics. By releasing nucleic acid compounds from endosomes where they are trapped following administration, PCI addresses one of the major bottlenecks facing this emerging and exciting field.  PCI Biotech follows a strategy to create value by improving the effect of existing cancer drugs and by realising the large potential in new therapeutics.

 

Targovax presents encouraging preclinical data on ONCOS-102

The International Journal of Cancer has recently published preclinical in vivo data in a mesothelioma xenograph model, demonstrating synergy of ONCOS-102 with pemetrexed and cisplatin, the current standard of care in malignant pleural mesothelioma. 

 

“These findings give a strong rationale for the clinical testing of ONCOS-102 in combination with pemetrexed and cisplatin in patients suffering from malignant mesothelioma. In fact, we recently started a clinical trial in malignant mesothelioma where this combination will be evaluated” says Lukasz Kuryk of Targovax Research & Development.

Malignant mesothelioma is a rare cancer type, often caused by exposure to asbestos. There are no curative treatments, although surgery, chemotherapy and radiotherapy can sometimes help to improve patient prognosis and life expectancy. Pemetrexed and cisplatin is the standard of care chemotherapy for malignant mesothelioma, but the median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is only approximately 12 months.

ONCOS-102 is a purposefully engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce a systemic anti-tumor T-cell response in cancer patients. In a previous Phase I trial, ONCOS-102 treatment induced tumor specific immune activation both at systemic and lesional level. The immune activation was associated with clinical benefit.

In the present preclinical study, an evaluation was made of the antitumor activity of combination treatment with chemotherapy (pemetrexed, cisplatin, carboplatin) and ONCOS-102 in a xenograft BALB/c model of human malignant mesothelioma. The study demonstrated that ONCOS-102 is able to induce immunogenic cell death of human mesothelioma cell lines in vitro and showed anti-tumor activity in the treatment of the in vivo xenograft model. While chemotherapy alone showed no anti-tumor activity in the xenograph model, ONCOS-102 slowed down the tumor growth. When both ONCOS-102 and chemotherapy were combined, a synergistic anti-tumor effect was observed.

Targovax is currently studying ONCOS-102 in combination with pemetrexed and cisplatin in a randomized Phase Ib/II clinical trial of up to 30 patients with malignant pleural mesothelioma. The trial has a phase Ib safety lead-in cohort of 6 patients. The trial dosed its first patient in June 2016. During 2016, Targovax will also initiate three other clinical trials in various solid tumor indications to study ONCOS-102 in combination with other treatments such as immune checkpoint inhibitors and DC therapy.

 

About Targovax:
Arming the patient’s immune system to fight cancer

Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.

ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system’s capacity to recognize and attack cancer cells.

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.

Find more info on www.targovax.no 

 

Positive clinical data on Blue Light Cystoscopy with Cysview®/Hexvix® presented at AUA

Photocure ASA announced today new data from a prospective multicenter ongoing registry study that shows Blue Light Cystoscopy (BLC) with Cysview® increases detection rates of flat, more aggressive non-muscle invasive bladder cancer lesions (carcinoma in situ (CIS)) as well papillary lesions over white light cystoscopy (WLC) alone. The data from the prospective registry, real life, study including 175 patients, was presented at the American Urological Association (AUA) annual meeting in San Diego, CA, May 6-10, 2016.

For more information see here.

Nordic Nanovector announces first patient enrolled in Arm 3 of expanded Phase 1/2 study of Betalutin® in NHL patients

Oslo Cancer Cluster member Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces that the first patient has been enrolled into one of the two new arms of its expanded Lymrit 37-01 clinical study with Betalutin®.

Betalutin® is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin’s lymphoma (NHL), including Follicular Lymphoma (FL). The new arm (Arm 3) is designed to investigate the safety and efficacy of Betalutin® in up to 12 patients with relapsed FL pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a few hours prior to the administration of Betalutin®.

Luigi Costa, Nordic Nanovector CEO, commented -We are pleased to initiate the first of the two new cohorts in our ongoing clinical study, which represents a significant step forward in Betalutin’s development plan. Data we have seen to date suggest that we can achieve strong clinical efficacy with a regimen that controls haematological side effects. The two new arms are investigating if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve even higher efficacy than that so far observed, and therefore an even more compelling product profile.

The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.
Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus 50mg/ml unconjugated “cold” HH1 anti-CD37 antibody) is progressing as planned with dose-escalation expected to begin in 2H 2016. Patient screening is also underway for the final arm in the expanded Lymrit 37-01 study (Arm 4), in which escalating doses of Betalutin® plus pre-treatment with a higher dose of cold anti-CD37 antibody than in Arm 1 will be evaluated in relapsed FL patients.

A decision to increase the dose of Betalutin to 17.5 MBq/kg in Arm 1 can be made based on the evaluation of the safety and efficacy data observed in the 15 patients treated with 15 MBq/kg. A decision to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or the other of Arms 3 and 4 can be made based on the evaluation of the safety and efficacy data observed in the first three patients of both cohorts.

Data and analysis recently published at the American Association of Cancer Research annual meeting (16-20 April) confirmed that Betalutin® was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) and a 31.6% Complete Response (CR) in evaluable patients. Clinical responses observed were sustained, with Duration of Response exceeding 12 months in most responders in the 15 MBq/kg group who have been followed up for at least 12 months.

www.nordicnanovector.com

Picture illustrating immuno-oncology on a molecular level.

Presentations from the Day of Immunology

The Norwegian Society for Immunology hosted their annual conference on the Day of Immunology on April 29. The theme for 2016 was Immunotherapy for Cancer. Below you may download some of the presentations as a courtesy of the lecturers.

 

 

Morning session (popularized science in Norwegian)

  • Immun mot kreft? Introduksjon til kroppens overvåkningstjenester
    Download the presentation here
    Anne Spurkland, Professor, avdeling for molekylærmedisin, Universitet i Oslo
  • Immunterapi: en revolusjon for kreftbehandling 
    Download the presentation here
    Else Marit Inderberg, PhD, avdeling for celleterapi, OUS Radiumhospitalet
  • Behandling av norske lungekreftpasienter med checkpoint-inhibitorer
    Download the presentation here
    Åslaug Helland, overlege og forsker, avdeling for onkologi, OUS Radiumhospitalet
  • Immunterapi virker – rapport fra en erfaren pasient
    Download the presentation here
    Kjell Stenstadvold

 

Afternoon session (scientific presentations made accessible for a broad public)

  • Sequential Intranodal ImmunoTherapy (SIIT) in malignant lymphoma
    Download the presentation here
    Arne Kolstad, MD, PhD, Department of Oncology, OUS Radiumhospitalet

 

 

Take the opprtunity to get more information on immunology on: http://norwegianimmunology.org and https://www.facebook.com/norwegianimmunology

Enhanced cystoscopy is recommended in the new AUA/SUO Bladder Cancer Guideline

Oslo, Norway, May 2, 2016: Photocure ASA announced today the American Urological Association (AUA) and the Society of Urological Oncology (SUO) have included enhanced cystoscopy in the 2016 Guidelines for the management of non-muscle invasive bladder cancer (NMIBC). Enhanced cystoscopy including Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® is recommended for increasing the detection and reducing recurrence of NMIBC.
For more information see here. 

Kristian Berg and Theodossis Theodossiou with prestigious EU-grant

Theodossis Theodossiou and Kristian Berg from the Photochemical internalisation (PCI) group at the Department of Radiation Biology at OUS have been funded by the Future and Emerging Technology (FET) program under the Excellent Science section of the Horizon 2020. The FET program funded 11 projects out of 820 grant applications (1,4 % success rate) and the proposal by Theodossiou and Berg was rated as number 6.

 

The project receives 3 million Euros together with 3 collaborating academic partners as well as one commercial partner (SME) from UK. The project, named Lumiblast, will be coordinated by Kristian Berg. This is the first time Norway is the coordinator of a FET project.

The aim of the project is to develop a specific non-invasive treatment modality based on two tumor targeted compounds (A and B in the illustration) that are alone inactive, but together interact by photon-based energy transfer resulting in excitation of the photon-acceptor compound followed by cytotoxic reactions.

The project is designed to develop treatment of aggressive brain tumors such as glioblastoma multiforme (GBM). Brain cancers like GBM are practically incurable due to their location, invasiveness and highly aggressive nature. The use of photon-based treatments of GBM has been clinically evaluated, but with limited success. This is mainly due to the limited propagation of photons in tissues and the efficient spread of tumor cells typically up to at least 2 cm from the resection margin.

Moreover, the existing photon based treatments are highly invasive and usually require open-cranium surgery, due to the need for external light. In the Lumiblast project the photons are produced inside the tumor cells avoiding the major limitation of using external light sources, to treat solid deep-sited and inaccessible tumors. The principle utilized in Lumiblast may also be relevant for treatment of cancers of other origins.

TheoKristian 2014

In addition to OUS, the partners include:

  • National and Kapodistrian University of Athens, Greece
  • Universitat Politècnica de València, Spain
  • University of Oslo, Department of Pharmaceutics, Norway
  • Knight Scientific Limited, UK

 

 

DoMore! receives Lighthouse project grant from the Norwegian Research Council

The Norwegian Research Council IKTPLUSS has selected The DoMore! project application as one of the 3 winners of the prestigious Lighthouse Project grant. The Lighthouse Project winning proposals were announced at the Norwegian E-health conference on the 26th april 2016.

 

The DoMore! project aims to explore the unique combination of academic and industrial competence within the project group to radically improve prognostication and hence treatment of cancer by using digital tools for pathology. ​The DoMore! project focuses on heterogene​​ity in cancer​ and is led by Institute Director Håvard Danielsen.​

​By largely digitalizing and automating diagnostics and prognostication of cancer, we can literally DoMore! and analyze a ​greater number of samples from the same tumor​,​ ​leading to a more precise diagnosis for each patient​ ​​​​Safe storage, analysis and prosessing of the​ ​B​ig ​D​ata​ the project will produce will also be handled by the project partners.

The ​DoMore!​ ​team ​is composed ​of experts within several fields, including: digital imaging, processing, robotics, pathology, cell biology, surgery and oncology, both in Norway and abroad​​. ​​Together, we will create solutions that will​​ ​​​​allow​ us to DoMore!, resulting in objective cancer diagnostics that can be made available to all patients.

New analysis shows Hexvix®/Cysview® significantly prolongs time to progression of bladder cancer

Photocure ASA Oslo, Norway, 26th April 2016: Photocure ASA (OSE: PHO), is pleased to announce publication of a new analysis demonstrating that Blue Light Cystoscopy (BLC) with Hexvix/Cysview significantly prolonged time to disease progression and showed a trend in the reduction of the rate of progression in patients with non-muscle invasive bladder cancer (NMIBC). The data was published online in the April issue of the peer reviewed journal, Bladder Cancer.

The new analysis of a long term follow-up study classified patients according to the new International Bladder Cancer Group (IBCG) definition of disease progression,  which was created to more accurately identify patients with high risk of developing invasive disease at an earlier stage, in order to optimize treatment decisions1. The data was published online in the April issue of the peer reviewed journal, Bladder Cancer.

Using the new IBCG definition, overall time to disease progression was significantly longer in the BLC with Hexvix/Cysview group (p=0.05). Additionally, there was a clear trend towards a reduction in the rate of progression, with 31 (12.2%) BLC with Hexvix/Cysview and 46 (17.6%) white light only patients progressing after 4.5 years (p=0.085). This trend was particularly pronounced in patients from having smaller, papillary lesions (stage Ta) to high risk flat lesions (CIS): 4 (1.6%) in the Hexvix/Cysview group compared to 11 (4.2%) in the white light group.

Dr. Ashish M. Kamat MD, MBBS, FACS Professor Department of Urology, Division of Surgery, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas and lead author on the publication commented “The updated findings support the importance of improved tumor detection and resection of bladder tumors at an early stage and its impact on the long term prognosis for patients.  These results confirm and extend the prior reported benefits of using BLC with Hexvix/Cysview over white light alone in the management of NMIBC.”

Dr. Kjetil Hestdal, President & CEO of Photocure ASA added: “We are delighted to see the ever growing body of clinical evidence that supports the beneficial impact of BLC with Hexvix/Cysview for bladder cancer patients.  Better detection and reduction in recurrence for patients undergoing BLC with Hexvix/Cysview has been extensively documented.  This long term follow-up study analyzed with the new definition of progression further demonstrates that BLC with Hexvix/Cysview plays an important role in the management of bladder cancer and provides patients with sustained and long term benefits.”

In the original analysis, published in the Journal of Urology in 2012, the definition of progression was from non-muscle invasive to muscle invasive bladder cancer.  That analysis demonstrated a prolonged time to recurrence with a trend towards less progression; after 4.5 years (median), 8 (3.1%) Hexvix/Cysview and 16 (6.1%) white light patients had progressed.

The new IBCG definition includes the following as indicators of disease progression: an increase in stage from Ta to CIS or T1, CIS to T1 (indicating invasion of the bladder lining or lamina propria), development of T2 or greater, lymph node disease (N+), distant metastasis (M1) or an increase in grade from low to high.

Hexvix/Cysview is a photosensitizing agent taken up selectively by the tumor cells in the bladder that when exposed to blue light during a cystoscopic procedure results in a bright pink fluorescence of the suspicious tissue. Using Hexvix as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence and prolongation in time to disease progression.

For more information see here.

Photo of Martin Bonde, Vaccibody

Apim, Vaccibody and Targovax will present at ICCS prior to BIO in San Fransisco

Oslo Cancer Cluster will for the 5th time arrange International Cancer Cluster Showcase, ICCS in collaboration with leading cluster partners from Europe and North America. 20 oncology biotechs will pitch their latest innovations and partnering opportunities.

Member companies pitching at ICCS are Apim Therapeutics, Vaccibody and Targovax.

Oslo Cancer Cluster will not feature a booth this year, but International Advisor Jutta Heix will be present at BIO and participate in partnering meetings as well as CEO Ketil Widerberg,

BerGenBio AS Presents New Data Demonstrating That BGB324 Enhances Checkpoint Inhibitor Blockade

BerGenBio AS (“BerGenBio” or the “Company”) announces that preclinical data demonstrating that lead compound, BGB324, combined with immune checkpoint inhibitors has the potential to synergistically improve treatment of human cancers, has been presented at the American Association of Cancer Research Annual Meeting (AACR), April 16-20, 2016 in New Orleans, Louisiana.

 

BGB324 is a first-in-class, highly selective, orally bioavailable small molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition (EMT), which is a key driver in immune evasion, drug-resistance and metastasis.

The poster presentation entitled: “BGB324, a selective small molecule inhibitor of the receptor tyrosine kinase AXL, enhances immune checkpoint inhibitor efficacy”, was held on Sunday April 17, 2016, 1:00 PM – 5:00 PM CDT as part of the session on Immune Modulating Agents 1. The data demonstrates that selective inhibition of Axl signalling with BGB324 significantly increased responsiveness to immune checkpoint blockade in syngeneic mammary and lung cancer mouse models. It was found that the combination of BGB324 with different immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1, anti-PD-L1) displayed increased infiltration of cytotoxic T lymphocytes and natural killer cells and significantly improved anti-tumour responses.

The full abstract (#566) can be viewed online through the AACR website.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

-We are pleased with the encouraging preclinical data on BGB324 presented at the annual AACR meeting. Whilst BGB324 is currently in clinical trials as a single agent and in combination with standard of care drug in acute myeloid leukaemia, and in combination with erlotinib in non-small cell lung cancer; this data suggests it also has the potential to be used in combination with immune checkpoint inhibitors, an important emerging class of anti-cancer drug, to enhance their efficacy.

About BerGenBio AS

BerGenBio AS is a clinical stage biopharmaceutical company focused on developing first-in-class drugs for aggressive cancers. The company is a world leader in understanding the biology of epithelial-mesenchymal transition (EMT), a widely recognised key pathway in immune evasion, acquired cancer drug-resistance and metastasis. BerGenBio AS is founded on proprietary platform technology, CellSelect™, to identify and validate novel drug targets and biomarkers. The company has progressed its lead drug candidate BGB324, an EMT inhibitor, into clinical trials in AML and NSCLC, while pursuing the pre-clinical development of additional compounds and proprietary EMT drug targets. For more information see here.

Nordic Nanovector ASA: Betalutin® continues to show promising efficacy

Nordic Nanovector, a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces updated results of its ongoing Phase 1/2 study with Betalutin® in relapsed non-Hodgkin lymphoma (NHL) patients.

 

Betalutin® was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) including 31.6% Complete Response (CR) among 21 patients with previously treated CD37+ NHL patients. This data include two additional patients whose efficacy data has become available following submission of the abstract.

The data being presented in the poster at AACR are from the ongoing Phase 1/2 single dose, open label, dose-finding study investigating three dose levels of Betalutin® in 21 patients with relapsed CD37+ NHL, 19 with Follicular Lymphoma and two with Mantle Cell Lymphoma, previously treated with one to eight treatment regimens. One patient recruited into the study had transformed disease and was excluded from the response rate calculation.

The updated data in the poster confirm the favourable safety profile of Betalutin® and its promising efficacy as a single agent in patients who have failed many prior regimens, characterised by a sustained duration of response.

 

Key conclusions from the update include:

• Betalutin® is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible

• Betalutin® delivers a highly favourable response rate (best response) in this heavily pre-treated patient population (Overall Response Rate 63.2% and Complete Response 31.6%)

• The median Duration of Response (DoR) has not yet been reached. Clinical responses observed are sustained, with DoR exceeding 12 months in most responders

Luigi Costa, Nordic Nanovector’s Chief Executive Officer, commented: “These new data continue to confirm Betalutin’s efficacy potential and favourable safety profile. In addition, Duration of Response (DOR) in patients who responded to treatment with Betalutin® has further improved confirming the product’s potential to become a significant treatment of NHL. These encouraging results support the continued clinical development of Betalutin®. We are pleased with the progress that we are making in executing our revised Phase 1/2 study and look forward to confirming the optimal dosing regimen for the pivotal Phase 2 study, PARADIGME, expected in Q1 2017.”

Targovax reports immune response with reduced number of  TG01 vaccinations

Targovax has conducted an interim DTH immunological response evaluation assessing early immune activation following administration of TG01 in combination with gemcitabine in the ongoing Phase I/II trial. The results show that the modified and reduced vaccination schedule generated similar 8-week immune responses in patients with pancreatic cancer, as seen in the initial cohort.

In March 2015, Targovax announced the immune results from the initial part of the trial. 18 out of 19 patients were eligible for immune response assessment and 15 patients had established a detectable immune response. Targovax now announces, in a second part of the trial, where the overall number of vaccinations have been reduced, that 4 of the first recruited 5 patients (of a total of up to 13 patients) showed an 8-week immune response.

The trial is an open label, phase I/II trial of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas.

– It is encouraging to see that these interim DTH data from the cohort which received a reduced number of TG01 vaccinations show a similar level of 8-week immune activation as we saw in the earlier cohort which had received a higher number of TG01 vaccinations. We look forward to subsequent immune activation data for the remaining patients in this modified cohort and survival data which is expected during 2017 and 2018, says Gunnar Gårdemyr, CEO of Targovax.

About Targovax: “Arming the patient’s immune system to fight cancer”

Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aim to become a leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.

ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment may reinstate the immune system’s capacity to recognize and attack cancer cells.

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, more than 50 % of colorectal cancer and 20-30% of all cancers. Targovax works towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

The product candidates will be developed in combination with multiple treatments in several cancer indications, including checkpoint inhibitors. Targovax also has a number of other cancer immune therapy candidates in the early stage of development. For more information go to www.targovax.com.

Picture illustrating immuno-oncology on a molecular level.

View videos and presentations from Immuno-Oncology Educational Series 2016

The Immuno-Oncology Educational Series 2016 on April 6th featured cutting-edge presentations from leading Finnish and Norwegian clinicians and researchers within the field of cancer immunotherapy. Please see below for videos of the presentations and also some of the presentations.

 

  • Video

Please follow this link for videos of the presentations.

 

  • Presentations

The immunologists’ perspective: The dynamics of immunological signatures during cancer treatment

Dr. Alexandre Corthay, Head of Tumor immunology group; Department of Pathology, Oslo University Hospital, President of the Norwegian Society for Immunology

 

The molecular pathologists’ perspective: Immunological fingerprint in breast cancer patients – what does that mean?

Dr. Hege G. Russness, Dept. of Genetics, Institute for Cancer Research, and Dept. of Pathology, Oslo University Hospital

 

Presentations are published by courtesy of the lecturers.

 

Nordic Nanovector enters collaboration with Paul Scherrer Institute

Nordic Nanovector with research and development collaboration programme with Paul Scherrer Institute (PSI) in Switzerland. The collaboration aims at developing new antibody radionuclide conjugates (ARCs) optimised for the treatment of single cell leukaemias, such as chronic lymphocytic leukaemia (CLL) and acute myeloid leukaemia (AML).  CLL and AML are serious orphan diseases with a survival rate for AML at 5 years of only 26%, and 82% for CLL. It is a significant unmet medical need, which affect more than 50,000 patients per year worldwide. Together these two indications represent a growing market worth over USD 4 billion per year.

The collaboration will explore the use of different radionuclide payloads, provided by PSI, linked to Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) to combine specific tumour-targeting with tumour-eradicating radiation. Successful candidates are expected to be advanced into preclinical and clinical trials.

The collaboration will benefit from grant funding recently awarded to Nordic Nanovector from the Research Council of Norway’s user-driven research-based innovation program (in Norwegian; Brukerstyrt innovasjonsarena, BIA). (See link: BIA funding)

Nordic Nanovector’s Chief Scientific Officer, Jostein Dahle, commented  -We are delighted that, through this new collaboration, we can benefit from the world-class radionuclide research emanating from PSI to further enhance our own expertise in ARCs. We believe that the potential of our CD37-targeting approaches provides an excellent framework for us to create a pipeline of ARCs with profiles suitable for treating multiple types of leukaemia and lymphoma. This project is a positive step towards Nordic Nanovector’s mission of extending and improving the lives of patients with haematological cancers.

Nordic Nanovector’s most advanced ARC, Betalutin®, which comprises the murine anti-CD37 antibody (HH1) conjugated to lutetium-177, is currently in a Phase 1/2 clinical trial for the treatment of third and second line non-Hodgkin lymphoma (NHL).  Betalutin® has the potential to be a very valuable treatment alternative for NHL, another very serious and highly prevalent hematological disease, based on the promising efficacy, safety and sustained duration of response data that has been observed in clinical studies to-date.

Two new members in Oslo Cancer Cluster: Institute for Energy Technology – IFE and ONLY Oncology

Institute for Energy Technology – IFE and ONLY Oncology are now members of the Oslo Cancer Cluster. Please find more information on the new mwmbers below. IFE is also part of the Oslo Cancer Cluster Incubator. 

 

About Institute for Energy Technology – IFE
IFE is an independent international research foundation for energy and nuclear technology. IFE’s mandate is to undertake research and development, on an ideal basis and for the benefit of society, within renewable energy and environmental technology, oil and gas, nuclear medicine and nuclear safety, and to carry out assignments in the field of nuclear technology for the nation.

IFE was founded in 1948 as The Institute for Atomic Energy (IFA). IFA developed into Norway’s largest research institute, and in 1980 IFA changed its name to the Institute for Energy Technology – IFE. Since that time, the institute has further developed and become a leading international, experimental research institute. IFE has about 600 employees with headquarters at Kjeller, and research activities at Kjeller and Halden. IFE’s vision is to be an internationally leading energy research institute.

Every year one to two percent of Norway’s population undergoes a medical assessment using radioactive pharmaceutical products. The isotope laboratories at IFE are the Norwegian control organ for radioactive medicines. The laboratories are organized as a pharmacy and provide advice and guidance on the use of the products. The majority of radioactive medicines used in Norway are controlled at IFE before they are sent out to Norwegian hospitals.

The isotope Laboratories at IFE has significant expertise and know-how across the entire product development chain supported by experienced staff in radiochemistry and radiopharmacy.

IFE has dedicated laboratories for production, packaging and quality control of radiopharmaceuticals. These laboratories are classified in respect of cleanliness classes in accordance with international GMP (Good Manufacturing Practice) rules and in accordance with radiation protection legislation.

IFE has facilities and licenses for global distribution of radiopharmaceuticals for clinical and commercial phase.

IFE is a Contract Research Organization (CRO) for production of new radiopharmaceuticals. In addition IFE is a Contract Manufacturing Organization (CMO).  IFE has a dedicated manufacturing line for the contract manufacturing of Xofigo (a radiopharmaceutical based on the radioisotope Ra-223 and developed by Algeta in Norway). Xofigo has been manufactured by IFE for global supply since May 2013. IFE is also performing contract analyses. In addition IFE has facilities to conduct research with isotopes including production of new isotopes.

Website: www.ife.no 

 

About Only Oncology: 
Only Oncology is a specialist Oncology Medical Communications agency:

  • We have approximately 30 writers with oncology expertise, all are PhD’s
  • We have offices in the UK, (London and Manchester), and San Francisco and New York in the US
  • We work with both big pharma and biotech companies to ensure the clinical profile of the product is appropriately communicated to physicians, payers and most importantly the patient.

Activities in the oncology field:

  • Directing communication activities, from pre-clinical through Phase III and beyond
  • Support for strategic publication planning and writing. Including developing the core scientific statements used in all communications, corporate, and clinical
  • Setting up advisory panels to advise on the development programme focusing on meaningful clinical benefit and clinical study end points for regulatory approval
  • Delivering advisory boards clinical and payer
  • Identifying external experts across all tumor types
  • Aiding internal training (new starters, MSL’s etc.)
  • Writing Target Product Profiles

Website: www.onlyoncology.com

Photocure anoounces grant of patents for CEVIRA®

Oslo Cancer Cluster member Photocure announces that a new patent for Cevira® has been granted in Europe. Cevira® is one of Photocure’s promising pipeline products and is being developed as a new and innovative breakthrough for the treatment of precancerous lesions of the cervix.

The newly granted patent protects the Cevira® drug, its use and its combination with a drug delivery device, such as the Cevira® device, until 2030. This new key patent in Photocure’s Cevira® portfolio complements the company’s proprietary two European patents which protect different aspects of the Cevira® device, and which expire 2029.

Concurrently, the United States Patent and Trademark Office has issued a Notice of Allowance for Photocure’s patent application related to the Cevira® drug. A US patent protecting the Cevira® drug in a similar way as the above-mentioned European patent will issue shortly.

“The approval of this latest European patent and the Notice of Allowance for the equivalent US application is a key milestone for us in our continued work to secure the long-term value of Cevira®. The new patents further strengthen Photocure’s robust patent portfolio and provide Cevira® market exclusivity for the long-term. Cevira® is a key asset for us, with the potential to not only treat HPV induced cervical high grade disease but also to prevent the development of cervical cancer, which affects more than 500,000 women annually”, said Kjetil Hestdal, President and CEO of Photocure.

For more info: www.photocure.com

Beslutningsforum sa nei til brystkreftmedisin fra Roche – for andre gang

Kadcyla (trastuzumab emtansin), til behandling av en undergruppe brystkreftpasienter, ble i dag ikke godkjent av Beslutningsforum for behandling av norske pasienter.

-Vi er svært overrasket og skuffet over dagens beslutning om at norske pasienter ikke får tilgang til den nyeste brystkreftmedisinen som allerede er i bruk i de fleste vesteuropeiske land. Roche harstrukket seg langt, både økonomisk og i variasjon av betalingsløsninger i de til sammen seks pristilbudene, for å imøtekomme beslutningstagernes ønsker. Vi opplever at våre laveste pristilbud ikke blir akseptert fordi myndighetene sier nei til å ta i bruk moderne prisløsninger. Norske pasienter går  dermed glipp av muligheten til livsforlengende og mer skånsom behandling, sier kommunikasjonsdirektør Line Walen i Roche Norge.

Roche har siden februar 2014 presentert flere forskjellige rabattløsninger til myndighetene. Noen av tilbudene innebærer et lavere kostnadsnivå, men har blitt avvist fordi de fordrer moderne prisløsninger. Slike betalingsløsninger krever noe innsats fra myndighetene ved å ta i bruk eksisterende systemer ved sykehusene. Slike løsninger er allerede tatt i bruk i flere andre land i Europa.

– Vi forstår at myndighetene står overfor vanskelige prioriteringer. Samtidig bør alvorlig syke pasienter og deres leger ha mulighet til å velge de beste behandlinger som fins i dag. Kadcyla vil være aktuell for omtrent 100 pasienter årlig, og vil dermed medføre en begrenset utgift for sykehusene, sier administrerende direktør Elizabeth Jeffords i Roche Norge.

Kadcyla har helt siden september 2014 vært anbefalt i Norsk Bryst Cancer Gruppes medisinske retningslinjer for behandling av de aktuelle brystkreftpasientene. Behandlingen ble godkjent for salg i Norge av regulatoriske myndigheter i november 2013.

– Vi ønsker å samarbeide tettere med myndighetene for å finne rabattløsninger som er bærekraftig både for myndighetene og industrien slik at også norske pasienter skal få tilgang til våre medisiner. Vi håper dette bidrar til videre diskusjon for Kadcyla og andre nye medisiner, sier kommunikasjonsdirektør Line Walen i Roche Norge.

 

Norge i selsomt selskap

Kadcyla er i bruk i det offentlige helsevesenet i Sverige, Danmark, Finland, Irland, Belgia, Nederland, Østerrike, Sveits, Storbritannia, Frankrike, Tyskland, Italia, Spania, Tsjekkia, Bulgaria og Hellas. Land som har tatt Kadcyla i bruk basert på Roche-avtaler for enkelte sykehus og forsikringsselskaper er Portugal, Slovakia, Kroatia og Ungarn.

Land som ikke har tatt i bruk Kadcyla er Norge, Estland, Latvia, Litauen, Polen, Slovakia og Romania.

Kadcyla benyttes til behandling av HER2-positive  brystkreftpasienter etter progresjon. En positiv beslutning ville gitt om lag 100 norske brystkreftpasienter et behandlingstilbud som kan forlenge overlevelsen med 5,8 måneder (median), sammenlignet med kombinasjonen lapatinib og kapecitabin. Brystkreft med spredning er en dødelig sykdom. Pasientene taper mange leveår og har lavere livskvalitet på grunn av sykdommen. Kadcyla er et innovativt  biologisk legemiddel som hovedsaklig angriper kreftcellene i stedet for kroppens friske celler. Dette medfører mindre bivirkninger slik at pasientene kan oppleve god livskvalitet under behandlingen med Kadcyla.

Roche’ medisinske bidrag har endret behandlingen og utsiktene for HER2-positive brystkreftpasienter i betydelig grad. Før Roche’ banebrytende medisiner Herceptin, Perjeta og Kadcyla, overlevde pasienter i gjennomsnitt i 20,3 måneder. Etter Herceptin og Perjeta er overlevelsen for denne aktuelle pasientgruppen nesten tredoblet, til 56,5 måneder. Kadcyla kan ytteligere forlenge overlevelsen for denne hardt rammede pasientgruppen.

 

Fakta:

Om Kadcyla
Kadcyla er det første innovative legemidlet til behandling av brystkreftpasienter hvor cellegiften er koblet til et antistoff. Dette gjør at cellegiften kun påvirker de HER2-positive kreftcellene.

Kadcyla, som monoterapi, er indisert til behandling av HER2-positiv, inoperabel lokalavansert eller metastatisk brystkreft som tidligere har fått behandling med trastuzumab og et taxan, alene eller i kombinasjon. Pasienter bør enten ha: mottatt tidligere behandling for lokalavansert eller metastatisk sykdom, eller utviklet tilbakefall av sykdommen under eller innen seks måneder etter forebyggende behandling.

Kadcyla gis intravenøst hver 3. uke og pasientene bør behandles inntil sykdomsprogresjon eller uakseptabel toksisitet.

Ved å benytte Kadcyla kan totaloverlevelsen økes samtidig som pasienten opplever en bedret og annerledes

bivirkningsprofil enn ved behandling med ulike typer cellegift. Totaloverlevelsen økte med nesten et halvt år i EMILIA-studien, fra 25,1 til 30,9 måneder sammenlignet med kontrollarmen (lapatinib og kapecitabin). I samme studie ble det også vist at pasienter som fikk Kadcyla opplever å ha en bedret helserelatert livskvalitet sammenlignet med kontrollarmen. Totaloverlevelse er også vist i TH3RESA-studien,  med en økning på nesten 7 måneder  (15,8 måneder til 22,7 måneder) sammenlignet med kontrollarmen der legen selv kunne velge type behandling.

Om brystkreft
Brystkreft er kreft i brystkjertelvev, og er den hyppigste kreftformen blant kvinner i Norge. I 2014 var det 3324 kvinner og 24 menn som fikk diagnosen. Samme år var det 663 kvinner og 6 menn som døde av brystkreft. Andelen kvinner som er i live fem år etter å ha blitt diagnostisert med brystkreft har økt kraftig, og er nå i underkant av 90 prosent.

Lokalt avansert brystkreft og metastatisk brystkreft er de mest alvorlige formene for brystkreft. Ved metastatisk brystkreft har kreften spredt seg til andre deler av kroppen, som oftest lunger, lever, hjerne og skjelett. Det finnes ingen kurativ behandling og prognosen er dårlig for disse pasientene.

I Norge er 15 prosent av kvinner med brystkreft HER2-positive. Økt forekomst av HER2-proteinet gir mer celledeling og cellevekst, og ubehandlet er HER2-positive svulster forbundet med en mer aggressiv sykdom, økt risiko for tilbakefall og kortere overlevelse.
Om Roche
Roche er ledende innen forskningsbaserte helsetjenester med fokus både på legemidler og diagnostikk. Roche er verdens største bioteknologiselskap med innovative medisiner innen onkologi, immunologi, infeksjonssykdommer, oftalmologi og nevrologi.  Roche er også nummer én på verdensmarkedet innen in-vitro diagnostikk, vevsbasert kreftdiagnostikk, og er en pionér innen diabetesbehandling. Roche’ strategi for persontilpasset behandling tar sikte på å forske fram og utvikle medisin og diagnostikk som i betydelig grad bedrer folks liv og helse.
Roche ble grunnlagt i 1896, og har kommet med viktige medisinske bidrag i over ett hundre år. I alt 29 medisiner, utviklet av Roche, er inkludert i Verden helseorganisasjons liste over essensielle legemidler, blant dem livreddende antibiotika, antimalariamedisin og kjemoterapi.

I 2014 hadde Roche-konsernet 88 500 medarbeidere over hele verden, investerte over 60 milliarder norske kroner i forskning og utvikling, og hadde rundt 340 000 pasienter i kliniske studier. Genentech i USA er et heleid selskap i Roche-gruppen. Roche er majoritetseier i Chugai Pharmaceutical i Japan. For mer informasjon, se ww.roche.com

 

Artikkelen er basert på pressemelding fra Roche. Roche Norge er medlem av Oslo Cancer Cluster.

 

 

Oslo Cancer Cluster & NCE Smart Energy Markets: Partners in prestigious Horizon 2020 EU project of 45 MNOK

Oslo Cancer Cluster and NCE Smart Energy Markets together with four European clusters in medicine and IT managed to land a prestigious Horizon 2020 EU project. The EU project will use innovative IT solutions to develop personalized cancer treatment. Allocated funds is 45 million, of which 34 million is earmarked for small and medium enterprises in the clusters.

 

The EU project has the sounding name “Personalised Medicine Innovation trough Digital Enterprise Solutions: PERMIDES”, will utilize the digital revolution to develop new systems for cancer treatment. This will be achieved by matching the small and medium enterprises within IT with cancer biotechs in the six clusters. This matching shall take place both virtually and physically. Utilization of accumulated expertise in Big Data Analytics from other industries, such as energy industry, will enable the development of digital systems and solutions.

 

Developing cancer treatment smarter

– More and more people are diagnosed with cancer, both because the population is steadily increasing, but also because people get older. There is a crying need for innovative cancer treatment. Health care institutions as well as many biotech companies are lagging behind in adopting the latest digital solutions. For Norway in a time of souring oil prizes and in need of new industries, PERMIDES is an important project that will develop solutions for tomorrow’s business community, says Ketil Widerberg, CEO of Oslo Cancer Cluster.

 

Digital revolution from energy to medicine

– The world has just begun to discover the enormous potential Big Data Analytics will represent for society and business. PERMIDES will contribute to research that may save the lives of many people in the coming years. It is the unique competence across clusters that is the core of this project: The transfer of unique Big Data Analytics expertise from smart energy to personalized medicine, says Dieter Hirdes, F & I Coordinator Smart Innovation Østfold company as a leader NCE Smart cluster .

 

Excellent revue

PERMIDES succeed in landing the EU support as one of five projects of 115 applications. It received a score of 14 of a possible 15, and is thus in the top range. Those companies that match each other can get up to 600 000 NOK in direct support. PERMIDES ends in 2019, and the goal is then that:

  • 120 IT companies and cancer biotechs have benefited from technology transfer activities
  • 75 enterprises have participated in networking conferences at regional and European level
  • 100 companies have placed its profile in a semantic matchmaking portal
  • 90 innovation projects is ongoing between IT and cancer biotechs through a voucher system

 

Facts

Oslo Cancer Cluster and NCE Smart Energy Markets are two of 14 clusters in the Norwegian Centres of Expertise program.

Oslo Cancer Cluster is a research and industrial cluster within cancer and gathers over 75 research institutions, hospitals, biotech firms and biopharmaceutical companies from all over Norway and Northern Europe. The cluster’s vision is to accelerate the development of innovative cancer treatments for the benefit of cancer patients. In August 2015 Oslo Cancer Cluster Innovation Park and Incubator opened its premises next to the Radium Hospital in Oslo. The incubator aims to contribute to more entrepreneurial businesses based on cancer research: Today the Incubator comprise of lab and office space to more than 25 institutions: www.oslocancercluster.no // www.occincubator.com.

 

Smart Innovation Østfold heads NCE Smart Cluster and has since 2009 initiated or participated in 20 different research and innovation projects (F & I) with a total budget of over 300 MNOK. Four of which are EU projects. Smart Innovation Østfold heads Horizon 2020 project EMPOWER with a budget of more than NOK 60 million. NCE Smart cluster comprise of a number of IT companies and academic communities who hold the leading expertise in Big Data Analytics now used in smart energy. The technology is generic, and it is therefore great potential to transfer this expert knowledge to applications in personalized medicine.

 

 “Personalised Medicine Innovation trough Digital Enterprise Solutions: PERMIDES»

Participants: Six clusters and two industrial partners in IT.

  • Oslo Cancer Cluster SA
  • SMART INNOVATION ØSTFOLD
  • TECHNISCHE Universitaet DARMSTADT
  • Cluster Individualisierte Immunintervention (CI3)
  • intelligent views gmbh
  • NETSYNO Software
  • ONCOTYROL-CENTER FOR Personalized CANCER MEDICINE
  • BUSINESS UPPER AUSTRIA

Targovax with encouraging interim results on RAS specific peptide vaccine in resected pancreatic cancer

Oslo Cancer Cluster member Targovax has conducted a predetermined interim analysis of the TG01 Phase I/II trial, indicating promising 1-year overall survival data when combining TG01 with gemcitabine, chemotherapy, as supplementary treatment of patients with pancreatic cancer.

 

Of the 19 patients included in the study, 15 patients provided consent to be followed up for survival and four patients did not provide consent to be followed up. 1-year survival data showed that 14 out of these 15 patient were alive and one passed away due to pneumonia assessed by the investigator as unrelated to the patients underlying cancer.

The regimen was generally well tolerated and RAS specific T-cell immune responses were induced and enhanced when TG01/GM-CSF was administered in combination with gemcitabine (1).

“One must be careful when drawing conclusions from small survival trials, but this result is an encouraging signal of efficacy and we look forward to the two year survival data which is expected during the first half year of next year“, says Gunnar Gårdemyr, CEO of Targovax.

The study is a single arm study of TG01 in combination with standard of care gemcitabine as adjuvant treatment of patients with operable pancreatic cancer. The interim analysis covered 1-year survival of the first cohort of 19 patients.

References: 1-year overall survival in two independent studies of patients with resected adenocarcinoma of the pancreas receiving standard of care gemcitabine were both approximately 75% (2,3).

 

About Targovax: “Arming the patient’s immune system to fight cancer”

Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a leader in its area. The company is currently developing two complementary and highly targeted approaches to immuno-oncology:

ONCOS- 102 is part of a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment may reinstate the immune system’s capacity to recognize and attack cancer cells.

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancers and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

The product candidates will be developed in combination with multiple treatments in several cancer indications, including checkpoint inhibitors. Targovax also has a number of other cancer immune therapy candidates in early stage of development. For more information go to www.targovax.com

Professor Kjetil Taskén at the University of Oslo awarded King Olav V’s Cancer Research Award 2016

King Olav V’s Cancer Research Award 2016 is presented by HM King Harald V on behalf of the Norwegian Cancer Society in Oslo on 6 June. Taskén, who is director of the Biotechnology Centre and the Norwegian Centre for Molecular Medicine (NCMM), receives the award for his work with immunotherapy. He has contributed greatly to the understanding of immuno-oncology. Research that will be even more relevant in the development of next generation immunotherapy.

Professor Kjetil Taskén. Photo: nyebilder.no
– Sometimes our immune system turn of the ability to recognize and kill cancer cells in tumors that grow. We try to find out why – and how we can get the mechanisms started again, says Kjetil Taskén.

– I was very happy to know that I received the prize. King Olav V’s Cancer Research Award hangs very high and I am honored to receive the award. The money will come very handy in the research my group is doing. We greatly appreciate the support from the Norwegian Cancer Society. The support has been of  invaluable importance in the development of all the work my research group does, says Kjetil Taskén. The prize is one million NOK.

King Olav V’s Cancer Research Award is given to scientists who have distinguished themselves through years of efforts to ensure a better life for many people.

– The price is a scientific recognition for excellence and are valued very highly among our cancer researchers, says Secretary General Anne Lise Ryel.

– We are awarding this prize annually to honor researchers. It is a distinction that means they have made an extraordinary effort both in Norway and internationally, says Ryel.

– We are especially pleased to give the prize to a researcher who works with immunotherapy, which many believe is the future of cancer treatment. Immunotherapy can contribute to a treatment that is tougher against cancer, but kinder to the patient, says Ryel.

 

This is an English translation of a news story from the Norwegian Cancer Society.

Photo of Martin Bonde, Vaccibody

Vaccibody completes enrolment of 12 patients for phase I/II study

Martin Bonde, CEO Vaccibody. Photo: Henriette Dan Bonde

Oslo Cancer Cluster member Vaccibody AS announced the successful enrolment of all twelve patients required for the phase I part of the multicentre trial VB C-01 – an exploratory, open-label, multicenter phase I/IIa study of VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).

 

As per protocol twelve eligible patients are needed to study the safety and immunogenicity of two different dosing schedules of VB10.16 in patients diagnosed with CIN 2 during this first phase I part of the study. Patient number 12 received her first vaccination on Friday 26 February 2016. The best schedule will be selected and evaluated in the subsequent phase IIa expansion part in both CIN 2 and CIN 3 patients.

The primary objective of the study is to evaluate the safety and tolerability of three doses of 3 mg VB10.16. The secondary objectives are to assess T cell mediated immune responses in the peripheral blood as well as in the pre-malignant tissue of the CIN 2/3 lesions and to evaluate early signs of efficacy by means of HPV clearance and CIN regression.

Martin Bonde, CEO of Vaccibody, commented – The successful completion of enrolment of the required number of patients for the phase I part of the study is an important milestone for Vaccibody. Positive results from this trial will have a significant impact not only on the development of the company’s lead product VB10.16 but also represent a proof of principle for Vaccibody’s Vaccine Platform Technology and the potential to use this platform in further indications.

 

About VB10.16

The company’s lead product, VB10.16, is a therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies.

 

About Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer

Per year approximately 530,000 women are diagnosed with cervical cancer worldwide and over 275,000 women die of the disease annually. Invasive cervical cancer is preceded by a long phase of pre-invasive disease called Cervical Intraepithelial Neoplasia (CIN). Globally the number of high grade lesions (CIN 2/3), the immediate precursors to malignancy, is estimated to be in the range of 10 million.

Virtually all cervical cancers are caused by high risk HPV types. Among the different high risk HPV types known, HPV16 has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It can be detected in up to 60 % of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers).

Current standard therapy for CIN 2/3 varies between countries and regions and often involves surgical removal of the affected tissue. These invasive procedures are associated with bleeding, infection, cervical stenosis, scarring and most importantly pre-term deliveries in subsequent pregnancies. As a result, there is a significant need for an effective therapeutic vaccine to treat existing HPV infection and associated pre-malignancies and malignancies of the cervix and thereby prevent the development of cervical cancer caused by human papillomavirus.

 

About Vaccibody AS

Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases,

for human and veterinary use. Vaccibody’s lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3). Also, Vaccibody is exploring the novel and promising area of neoantigen-based individualized cancer vaccines and is using the Vaccibody technology to generate first-in-class therapeutics to treat cancers with a high unmet medical need.

www.vaccibody.com

 

 

Photocure: Results from 2015

Oslo Cancer Cluster member Photocure had a great year in 2015 with increased sales. Photocure is a Norwegian specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, listed on the Oslo Stock Exchange.

 


Highlights include:
(Numbers in brackets and comparisons are for the corresponding period in 2014.)

  • Hexvix/Cysview global in-market sales increased 22% to NOK 59 million in the fourth quarter and 20% for the full year to NOK 215 million. Full year in-market unit sales increased 7%
  • Sales revenues increased 34% in fourth quarter. Full year sales revenues increased 31% to NOK 122.3 million (NOK 93.6 million)
  • Commercial segment EBITDA increased 70% to NOK 28.7 million (NOK 16.8 million) with EBITDA margin at 21% (17%) for the full year
  • Visonac® phase 2b clinical trial results published in the British Journal of Dermatology
  • Cash and cash equivalents of NOK 134 million as of 31 December 2015

 

President & CEO Kjetil Hestdal comments: “Throughout 2015, we made great strides towards our goal of building Photocure into a Specialty Pharma Company. Consistent with 2014, we continued to drive revenue growth in all major regions in 2015, while continuously increasing the profitability of our urology focused commercial franchise. Hexvix/Cysview market share continues to grow in the TURB segment across the major markets, and we have started a substantial effort to penetrate the large bladder cancer surveillance segment. Through new partnerships signed in 2015, Hexvix/Cysview will expand into Canada, Australia and New Zealand.

We also continued advancements in our product pipeline this past year. With Cevira, we gained alignment with the US FDA on the pivotal registration program. In addition, the long term value of our novel late stage, phase 3 ready assets, Cevira and Visonac, were further strengthened with issuance of new patents.”

Picture: Faximile fra VG

 

Nordic Nanovector will present at AACR

Nordic Nanovector ASA (OSE: NANO), a company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology, announces that a late-breaking abstract on its Phase 1/2 clinical study with Betalutin® has been accepted for presentation at the American Association For Cancer Research (AACR) annual meeting (16-20 April 2016, New Orleans, LA, USA).

The poster will provide an update of safety, clinical results and duration of response (DOR) from its ongoing Phase 1/2 study in subjects with relapsed non-Hodgkin lymphoma (NHL).

The abstract is expected to be available on the AACR website on Friday, 15 April 2016.

 

About the AACR annual meeting

The AACR Annual Meeting is a must-attend event for cancer researchers and the broader cancer community. This year’s theme, “Delivering Cures Through Cancer Science,” reinforces the inextricable link between research and advances in patient care. There will be a number of presentations that include exciting new data from cutting-edge clinical trials as well as companion presentations that spotlight the science behind the trials and implications for delivering improved care to patients.

This multidisciplinary program will include an outstanding roster of speakers, hundreds of invited talks, and more than 6,000 proffered papers from researchers around the globe. As always, the diversity of the AACR Annual Meeting program will give presenters a forum to share critical updates in all areas, as well as members of the audience an opportunity to actively participate in discussions with colleagues.

 

 

 

About Nordic Nanovector

Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.

Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.

Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications.

Further information about the Company can be found here.

Curida teams up with leading Nasal Spray Expert, strengthening Development Services

The Oslo Cancer Cluster Member Curida, which is a Contract Development and Manufacturing Organization (CDMO) based in Norway, strengthens its Development Services with a strategic partnership with Dr. René Bommer. Dr. Bommer is known for his competency within Nasal Spray and chairs the annual Nasal Drug Delivery conference. He is also a member of the jury panel at CPHI Pharma Awards. In July 2015, Curida acquired a Takeda manufacturing site with more than 25 years of nasal spray manufacturing experience.

Dr. René Bommer commented, – Curida’s holistic business approach to consider the unity of product content and delivery device in the development and in the further manufacturing process puts them into a leading position in the pharmaceutical industry. I am delighted to cooperate with such well-focused company and to contribute actively to the business success of Curida.

– We are very happy and proud to having Dr. Bommer joining our team. His knowledge and experience within this complex field is impressive. I have already had the fortune to work with him on a project and his blend of technical in-depth knowledge coupled with a commercial mind-set is quite rare and a strong asset, says Morten Steinvåg, Sales Director at Curida.

Curida’s development expertise covers the full service for the development of nasal and inhalation drug products (OINDP). The cGMP compliant laboratory service includes the extensive performance characterisation studies for nasal and inhalation drug products (OINDP) and other dosage forms provided with a delivery device, such as ophthalmic or topical products.

For the development of generic products, Curida is able to perform the regulatory challenging in-vitro bioequivalence studies and is responsible for the relevant CMC documentation for submission to the authorities.

Preservative free, sterile nasal and ophthalmic drug products fitted with multi dose delivery devices become more and more popular. In addition to physical device performance characterisation, Curida develops and validates the microbiological protocols and assesses the microbiological integrity of the product during shelf life and in particular during the in-use period.

Coupled with the manufacturing capabilities, Curida provides a one-stop solution from development to manufacture of drug products combined with a delivery device.

For more information see here.

Norways largest newspaper VG with broad coverage of cancer R&D in Norway

VG, one of Norway´s largest news paper, has issued broad coverage of Norwegian cancer R&D in their paper and online edition. The coverage includes an overview of the cancer treatment being developed by 10 of Oslo Cancer Cluster member companies.

 

IMG_1753 IMG_1756 IMG_1760photocure

Verdens kreftdag 4. februar: Tarmkreft den tause folkesykdommen

På Verdens kreftdag 4. februar retter Kreftforeningen, Oslo Cancer Cluster og Kreftregisteret søkelyset mot den tause folkesykdommen tarmkreft. Tarmkreftscreening kan redde livet til 300 nordmenn årlig. Det er tre ganger så mange som dør i trafikken hvert år.

– En rekke undersøkelser, både nasjonale og internasjonale konkluderer entydig at tarmkreftscreening redder liv. Bare i Norge kan dette trolig redde opp mot 300 hvert år. Det er tre ganger så mange som dør i trafikken. Hvor lenge skal dette egentlig utredes? Vi vet mer enn nok til å innføre et nasjonalt screeningprogram umiddelbart, sier Kreftforeningens generalsekretær, Anne Lise Ryel.

Hvert år rammes over 4000 nordmenn av  tarmkreft. Det gjør den til den nest  vanligste kreftformen. Den er samtidig blant kreftformene som tar flest liv. Hver dag dør fire. Bare lungekreft tar flere liv enn tarmkreft.  Likevel får sykdommen langt fra den oppmerksomheten den fortjener.

 

Befolkningsundersøkelse viser at få har kunnskap om tarmkreft

En fersk meningsmåling utført av TNS Gallup på vegne av Kreftforeningen, Oslo Cancer Cluster og Kreftregisteret viser at få er klar over den hyppige forekomsten. Undersøkelsen viser også at tarmkreft er den kreftformen vi tror er blant de mest dødelige og den vi frykter aller mest.

– Samtidig er tarmkreft en av de kreftformene vi har minst kunnskap om. Hele 80 prosent av de spurte svarte at de hadde dårlig eller ingen kunnskap om tarmkreft. Avisene skriver knapt om sykdommen. Dette er ikke bra, og vi har helt klart en jobb å gjøre med å informere bedre om en sykdom som rammer så mange, sier Ryel.

I forbindelse med Verdens kreftdag 4. februar arrangerer Kreftforeningen  et frokostseminar sammen med Kreftregisteret, Oslo Cancer Cluster og pasientforeningen Norilco  med tittel «Den tause folkesykdommen».  For selv om tarmkreft i snitt altså rammer mer enn elleve nordmenn hver eneste dag, er det «sykdommen ingen snakker om».

– Mens nesten åtte av ti svarer at de opplever mest åpenhet rundt det å ha brystkreft, kommer tarmkreft helt i den andre enden av skalaen. Tallene er ikke overraskende, men ikke desto mindre trist og urovekkende. Jeg vet om mange tarmkreftpasienter som synes det er vanskelig å snakke om at de har kreft i tarmen fordi det blir for intimt. Selv i vårt superåpne samfunn der vi deler alt med alle, er dette flaut. Sånn kan vi ikke ha det, sier Ryel.

 

Bør innføre tarmkreftscreening

I tillegg til å løfte tarmkreft frem i lyset, har Ryel en klar melding til helseministeren.

– Hovedproblemet med tarmkreft er at den er vanskelig å oppdage. Når symptomene melder seg, kan kreften dessuten allerede ha kommet langt.  Jo tidligere oppdagelse, jo større er sjansene for å overleve.  Den eneste måten å oppnå dette på, er å  innføre  et nasjonalt screeeningprogram for tarmkreft, sier Ryel.

Allerede i 2003 anbefalte EUs helseministere enstemmig en anbefaling om å innføre tarmkreftscreeening. Mer enn 20 europeiske land har fulgt anbefalingen, deriblant Storbritannia, Finland og Tyskland. I Norge har Kreftregisteret ansvar for et pilotprosjekt, der til sammen 140.000 personer mellom 50 og 74 år får invitasjon til å delta i screening. Foreløpig pågår prosjektet i Akershus, Buskerud og Østfold, og så langt har bortimot 93.000 personer fått invitasjon.  Prosjektet startet i 2012 men beslutningen om dette skal bli et tilbud til folk over hele landet har blitt utsatt en rekke ganger og  kommer trolig først etter at pilotprosjektet er avsluttet og evaluert i 2018.

 

Oncoimmunity, Vaccibody, Nextera and Nordic Nanovector granted BIA-funding

The Norwegian Research Council granted  Oslo Cancer Cluster member companies Oncoimmunity, Vaccibody, Nextera and Nordic Nanovector funding through the Programme for User-Driven Research Based Innovation (BIA).

In total, the Norwegian Research Council will grant 532 MNOK to 50 Norwegian companies, of which 10 are within biomedicine.

Oncoimmunity, Vaccibody, Nextera and Nordic Nanovector will receive between 15-20 million NOK each over 4 years, depending on the outcome of the contract negotiations between the council and the companies. Funding from the BIA programme is a quality stamp since the companies compete in “open class” where all sectors are represented.

 

Titles for the granted innovation projects:

  • Vaccibody: Targeted Personalized Therapeutic Cancer Vaccines
  • Nordic Nanovector: Development of Two New Antibody Radionuclide Conjugates for Treatment of Malignant Lymphoma and Leukemia
  • Oncoimmunity: Software for profiling tumor neo-antigens to empower cancer immunotherapy
  • Nextera: Novel targeted therapy for treating Leukemia

 

15 MNOK to Nordic Nanovector to develop targeted cancer treatments

Oslo Cancer Cluster member Nordic Nanovector ASA is awarded of a up to NOK 15 million grant from the Research Council of Norway’s User-driven Research-based Innovation programme (in Norwegian; Brukerstyrt innovasjonsarena, BIA) to support the research and development of novel targeted therapeutics for leukemia  and non-Hodgkin Lymphoma.

The award is based on the promising potential for value creation, both for patients and the society at large, as well as for Nordic Nanovector together with the high quality of research and innovation and the company’s international ambitions.

Nordic Nanovector’s Chief Scientific Officer, Jostein Dahle, commented: “This grant funding is important as it enables us to advance early stage research that leverages our expertise in ARC therapies, particularly around CD37-targeted approaches, as a means of developing a broader portfolio of products behind Betalutin® for treating malignant leukaemias and lymphomas.”

The grant will be paid over a three-year period. It is assigned to and will enable acceleration of the early stage project entitled “Development of Two New Antibody Radionuclide Conjugates (ARCs) for Treatment of Malignant Lymphoma and Leukemia”. The project is focused on development of ARCs consisting of a chimeric anti-CD37 antibody (chHH1) and a radioactive nuclide as the cytotoxic agent. chHH1 is a humanized version of the murine HH1 antibody, the tumour-targeting component of Nordic Nanovector’s lead candidate Betalutin®, which is currently advancing in a Phase 1/2a clinical trial for the treatment of third line and second line NHL.

Nordic Nanovector will construct and investigate ARCs with different payloads. These combinations have the potential to lead to product candidates with a range of drug profiles that may be applicable across multiple haematological malignancies. Successful candidates are expected to be advanced into clinical trials.

Established in 2006, the BIA programme is the largest industry-oriented programme at the Research Council of Norway (Forskningsrådet).  This broad-based programme supports high-quality R&D projects with good business and socio-economic potential.

 

 

About Nordic Nanovector

Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.

Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.

Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications.
Further information about the Company can be found at www.nordicnanovector.com

 

Vaccibody awarded 20 MNOK to develop patient-specific therapeutic cancer vaccines

Oslo Cancer Cluster member and therapeutic vaccine company Vaccibody today has received a grant up to NOK 20 million (USD 2.3 million) over four years from the Norwegian Research Council ‘s BIA Program to develop  therapeutic cancer vaccines based on each patient’s specific neoantigens.

 

Neoantigens are tumour- specific mutations in cancer cells. While most commonly shared tumour antigens used in cancer vaccines to date have to overcome central tolerance in the tumour, neoantigens are not subject to central tolerance. Recent success with related immunotherapies reveal the importance of immunity specific for neoantigens in patients with clinical benefit. This insight reveal an intriguing new interest in strategies that specifically stimulate neoantigen-specific immune responses, and neoantigen-based cancer vaccines should be particularly attractive.

The recent rapid development in sequencing and bioinformatics opens up the opportunity to rapidly identify immunogenic neoantigens and design patient-and tumor-specific cancer vaccines. Vaccibody’s DNA vaccine technology holds the potential to develop and produce highly effective neoantigen-based cancer vaccines. To increase the chance of success, Vaccibody has put  together a strong team with national and international partners with expertise in bioinformatics, vaccine delivery and translational research. The project seeks to complete a clinical proof of concept study with the neoantigen-based Vaccibody DNA cancer vaccines in advanced cancer patients.

Vaccibody has extensive experience within therapeutic DNA vaccine development. Preclinical models demonstrate highly improved efficacy of Vaccibody vaccines compared to other vaccine technologies for a range of disease models. The lead product, VB10.16 immunotherapy, is currently tested in a multicentre phase I/IIa study for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16). The expertise from the VB10.16 program will serve as an essential basis and speed up the clinical development of the neoantigen program.

“We are very encouraged by the support from BIA. This funding will help accelerate our efforts to explore our unique technology in an intriguing new field of cancer immunotherapy. We believe that the Vaccibody DNA vaccine platform is especially well suited for neoantigen-based cancer vaccine development and we are confident that we have put together a great team to support the entire chain of events needed to explore this exciting new project ” says CEO Martin Bonde.

About Vaccibody AS

Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) and was initiated in Q3 2015.

Contact:

Martin Bonde, CEO

+47 22958193

mbonde@vaccibody.com

 

 

View presentations and videos from Cancer Crosslinks

Cancer Crosslinks 2016 featured cutting-edge presentations from leading American and Norwegian clinicians and researchers within the field of cancer immunotherapy. You may look at their presentations again or for the first time via following the links below.  You may also watch videos of some of the presentations.

 

Picture above: The three Cancer Crosslinks 2016 keynote speakers.  From left: Professor Renier Brentjens, Dr. Stefanie Spranger and Professor Gordon Freeman.
Photo: U-Casters.

 

Videos:

International keynote presentations:

National presentations:

Presentations are published by courtesy of the lecturers.

PCI Biotech and Ultimovacs initiate preclinical research collaboration

Two of the Oslo Cancer Cluster biotech members situated in the Oslo Cancer Cluster Incubator; PCI Biotech and Ultimovacs, are initiating a preclinical research collaboration. The purpose of the collaboration is to utilise the companies’ complementary scientific platforms to explore potential synergies.

 

PCI Biotech, a cancer focused biopharmaceutical company, and Ultimovacs, a pharmaceutical company developing novel immunotherapy against cancer. Both companies are situated in the Oslo Cancer Cluster Incubator.

 

Cancer vaccination

The partnership is governed by a preclinical research collaboration agreement. In brief, the preclinical research collaboration will evaluate technology compatibility and synergy based on in vivo studies. The companies will evaluate results achieved from this research collaboration and then explore the potential for a further partnership.

Per Walday, CEO of PCI Biotech, said -I’m very pleased to announce our first research agreement in the field of cancer vaccination. We believe that the PCI technology has the potential to play a role in the realisation of several new therapeutic modalities, including cancer immunotherapy. Our preclinical research with other peptide vaccines have demonstrated strong enhancement of important cellular immunity responses and we look forward to explore synergies with Ultimovacs promising vaccination technology.

Øyvind Kongstun Andersen, CEO of Ultimovacs, said -Through this preclinical collaboration we are able to explore possible synergies between our two technologies. PCI has a very promising novel technology. Our therapeutic cancer vaccine is documented in patients to activate the immune system against cancer. We find it important for small biotech companies to collaborate and explore synergistic potential when there is an underlying scientific rationale. Such collaborative efforts may further strengthen the position of Norwegian companies within immunotherapy, which has become an important cancer treatment with a fast growing market.

About PCI Biotech
PCI Biotech is a cancer focused biopharmaceutical company headquartered in Norway and listed on the Oslo Stock Exchange (Axess). The company is developing therapeutic products based on its proprietary photochemical internalisation (PCI) technology. The PCI technology works by inducing triggered endosomal release and may be used to unlock the true potential of a wide array of therapeutic modalities, such as small molecules, vaccines and nucleic acids. The company has a clinical Phase I/II program in bile duct cancer, which is an orphan indication without approved medicinal products and a high need for better local treatments. The indication is well suited for PCI treatment, with easy light access through routine endoscopic methods and an active generic drug (gemcitabine) significantly enhanced by PCI. The company is also developing PCI as a vaccination technology. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines. The PCI technology is also very well suited for intracellular delivery of nucleic acids, such as RNA therapeutics. By releasing nucleic acid compounds from endosomes where they are trapped following administration, PCI addresses one of the major bottlenecks facing this emerging and exciting field. PCI Biotech follows a strategy to create value by improving the effect of existing cancer drugs and by realising the large potential in new therapeutics. http://pcibiotech.no

About Ultimovacs
Ultimovacs is a small pharmaceutical company developing novel immunotherapy against cancer. The leading product is UV1, a therapeutic cancer vaccine directed against human telomerase (hTERT). The vaccine is a result of many years of preclinical and clinical research at the Norwegian Radium Hospital. UV1 is a synthetic peptide vaccine. The peptides included in the vaccine is based on observation of immune responses in patients with advanced malignant disease surviving several years after vaccination with a hTERT based therapeutic cancer vaccine. The company is currently performing three clinical trials with UV1. Two trials are documenting safety and the vaccines ability to activate the immune system against cancer cells expressing the hTERT fragments that are the components of the vaccine when given on top of standard treatment in prostate cancer and lung cancer. A third clinical trial is assessing safety and clinical outcomes when combining UV1 with ipilimumab in patients with malignant melanoma. http://ultimovacs.com