News regarding investor opportunities in the Oslo Cancer Cluster Incubator

From the left: Director of Finance at Apotekforeningen Helge Ranvik, Chairman at Curida Per S. Thoresen, Director of Finance at Curida Terje Gabrielsen, CEO of Curida Leif Rune Skymoen, CEO of Ås produksjonslab Gro Noraker and CEO of Apotekforeningen Per T. Lund.

Curida Takover Secures Norwegian Production

To secure Norwegian pharmaceutical production, Oslo Cancer Cluster- member Curida has completed a takeover of Ås produksjonslab AS.

 

Continued Production at Ås
Curida operate in an international marketplace and here the last line of production of pharmaceuticals is mostly taken care of by specialized operators.

«Ås produksjonslab» is a company rich in tradition, it has nine employees and produces many products for Norwegian pharmacies, while also facilitating production on an assignment order basis.

Curida purchase Ås produksjonslab from The Norwegian Apothecary Society (Apotkerforeningen), a union of Norway’s 900 Pharmacies.

However, the lab will continue their production at Ås also after the takeover. And, with a yearly revenue of 21 million NOK, Leif Rune Skymoen, CEO at Curida, believes the takeover combined with the general growth of the company will help balance the budget the upcoming year.

— We are making these strategic moves because Curida gathered 50 million NOK in December by releasing an equal amount of stocks to Canica and Klavness Marine. Furthermore, Investinor was given an option on 25 million NOK worth of stocks, says Head of the Board of Directors, Per S. Thoresen at Curida. Investinor will decide at the end of January.

Securing Norwegian Expertise
As early as December Thoresen informed that part of the money gathered in the end of the year emissions would be used to buy production facilities.

And CEO Per T. Lund at The Norwegian Apothecary Society is also happy with the takeover. He says in a press release that this will contribute to a strong base of Norwegian pharmaceutical production. Additionally, it secures Norwegian Pharmacies delivery of pharmaceuticals in strong demand.

— We are strengthening Norwegian pharmaceutical production and securing important expertise, Thoresen explaines.

Curida is not only securing Norwegian production, they have also become important for Norwegian war time infrastructure. Late 2017 Curida signed a letter of intent with the Norwegian Armed Forces. They now supply raw materials and are responsible for pharmaceutical manufacturing in situations of emergency preparedness, which means in case of conflict, state of war or general emergency.

Breakthrough Agreement for Phoenix Solutions

A new exciting collaboration among two Oslo Cancer Cluster members has been initiated. GE Healthcare has agreed to be the manufacturer of the target drug delivery platform ACT, made by Phoenix Solutions.

Early Christmas Present
As an early Christmas present to each other the two companies announced that they had signed an agreement securing manufacturing for ACT, short for Acoustic Cluster Therapy, a technology platform for targeted drug delivery. CEO at Phoenix Solutions, Per Sontum, emphasized the importance of gaining a manufacturer that had experience with similar products.

“We are excited to sign this agreement and get GE on board as contract manufacturer of our product. With more than 20 years of experience producing Sonazoid and Optison, GE`s Oslo organization is the world leading site for the manufacturing of this class of pharmaceuticals.”

From GE`s Womb
The collaboration, however, is not totally out of the blue. Phoenix Solutions sprung out from GE Healthcare in 2013. GE`s General Manager for Norway, Bjørn Fuglaas believes this tie between the two companies is an advantage:

“We are very pleased that Phoenix has chosen to work with GE for this project, which is in line with the expectations we had when the company was spun out of GE in 2013. This is an area of interest and we believe GE to be uniquely positioned in this field given existing and strong capabilities within production of disperse pharmaceuticals, and microbubbles in particular”, he says.

This agreement also secures what is called Good manufacturing practice (GMP) for Phoenix Solutions. Making their product and company a safer potential for investors and further along in their development than time should suggest.

A Very Promising ACT
ACT is a special and interesting targeting device. It is an ultrasound mediated drug delivery system that specializes in beating the vascular barrier. It has a wide range of therapeutically useful applications, but Its primary use being the ability to deliver sufficiently high concentrations of drug to the tumor without contaminating its surroundings. Phoenix thinks ACT is a promising targeting system for pancreatic, liver, triple negative breast and prostate cancers, and has extremely promising pre-clinical results so far.

Chairman Roy H. Larsen proudly presents the new lab to interested visitors. Image: Oncoinvent.

Oncoinvent With New Lab and Bright Future

The cancer research company and Oslo Cancer Cluster-member Oncoinvent opened this Thursday a brand-new lab and research facilities at Nydalen Oslo. Now they control the whole production line and continue their development of their lead product candidate Radspherin.

A Good Year
2017 has been a good year for Oncoinvent. The company has now relocated and built new office and laboratory facilities, grown from four to twelve employees, and raised new capital. CEO at Oncoinvent Jan A. Alfheim believes that this represents a significant milestone for the company and will enable the company to further develop Radspherin®, a novel alpha-emitting radioactive microparticle designed for treatment of metastatic cancers in body cavities.

And Oncoinvent ends the year in fashion by opening brand new laboratory and research facilities. A lot of interested people came to tour the new facilities, observing an impressive lab with special infrastructure. Treating radioactivity, and circulating air in a facility that treats radioactive materials, calls for an extra advanced ventilation system.

Lab With all the Facilities
The idea of the new research facility is to be able to contain the whole production line, from research to drug manufacturing, to one location. All this contained in an area of 581 m2.

Creating a modern lab with the capabilities to treat radioactive materials in an active and well populated part of Oslo demands very strict guidelines. The production suites in the facility are constructed to be qualified for Good Manufacturing Practice (GMP) for production of Medical Product Candidates. Systems for purifying and monitoring of air and water quality as well as the removal of any potential radioactivity have been installed to ensure the safety of the operators, population and the environment.

The Production and Research areas of the laboratory will facilitate both the development of the Radspherin program and other discovery projects of the Company.

A Weapon for Precision Medicine
Radspherin® has been shown to cause a significant reduction in tumor cell growth an it is anticipated that the product can potentially treat several forms of metastatic cancer. Oncoinvent is developing Radspherin® as a ready-to-use injectable product that seeks out cancer tumors and destroys them from inside by emitting its radioactive content.

The first clinical indication for Radspherin® will be treatment of peritoneal carcinomatosis, a rare type of cancer that occurs in the peritoneum, the thin layer of tissue that covers abdominal organs and surrounds the abdominal cavity. Additionally, Oncoinvent has lined up a collaboration with European and American clinical research centers for the clinical development Radspherin®.

BerGenBio enters collaboration with MSD

Oslo Cancer Cluster member BerGenBio enters collaboration with MSD focused on clinical evaluation of BGB324 in combination with KEYTRUDA® (pembrolizumab) in advanced lung and breast cancer.

BerGenBio ASA is a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications. The company recently announced that it has entered into a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada) , through a subsidiary, focused on the clinical evaluation of BGB324 with KEYTRUDA® (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

BerGenBio’s lead candidate BGB324 is a first in class, highly selective, potent and orally available small molecule Axl kinase inhibitor in clinical development in a variety of cancer indications. The Axl tyrosine kinase is a key driver of cancer spread, immune evasion and drug resistance – the cause of the majority of cancer-related deaths. Increased understanding of the role of Axl in suppressing innate immunity supports the rationale for evaluating BGB324 in combination with KEYTRUDA.

Under the terms of the collaboration with MSD, BerGenBio will conduct two international Phase II studies to evaluate the potential clinical synergy of combining BGB324 with MSD’s anti-PD-1 therapy, KEYTRUDA. Details of the studies are as follows:

  • BGBC007 – A Phase II multi-centre study of BGB324 in combination with KEYTRUDA in patients with previously treated, locally advanced or unresectable TNBC.
  • BGBC008 – A Phase II multi-centre study of BGB324 in combination with KEYTRUDA in patients with previously treated unresectable adenocarcinoma of the lung.

Biomarker studies will be conducted in parallel to the above studies with the goal of developing companion diagnostics to identify patients who would be most suitable for treatment with the BGB324/KEYTRUDA combination.

The clinical trials will be sponsored by BerGenBio while MSD will provide the trial with KEYTRUDA. The rights to the study results will be shared. No further details are disclosed.

BerGenBio is investigating BGB324 in multiple cancer indications based on preclinical and early clinical findings. Phase II studies with BGB324 as a single agent in relapsed acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS); and in combination with erlotinib (TARCEVA®) in advanced EGFR-positive NSCLC are in progress.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are delighted to enter this collaboration with MSD, a leader in developing novel cancer therapies. This new agreement gives us the opportunity to evaluate the clinical potential of BGB324 in combination with KEYTRUDA in advanced lung and breast cancer; two of the areas of significant unmet medical need. We believe that BGB324 is a unique drug candidate that addresses a critical cancer mechanism responsible for promoting immune evasion. We believe the clinical utility of BGB324 in combination with immunotherapies has enormous potential. BerGenBio is excited to advance BGB324 in combination with KEYTRUDA into Phase II trials and we anticipate results in mid-2018.”

About BerGenBio ASA
BerGenBio (Bergen, Norway) is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple cancer indications. The Company is a world leader in understanding the central role of Axl kinase in promoting cancer spread, immune evasion and drug resistance in multiple aggressive liquid and solid cancers.

BerGenBio’s lead product, BGB324, is a selective, potent and orally available small molecule Axl inhibitor in Phase II clinical development in three major cancer indications. It is the only selective Axl inhibitor in clinical development. BGB324 is being developed by BerGenBio as a single agent therapy in acute myeloid leukaemia (AML)/myeloid dysplastic syndrome (MDS) and in combination with TARCEVA® (erlotinib) in advanced non-small-cell lung cancer (NSCLC); and in combination with KEYTRUDA® (pembrolizumab) in advanced NSCLC and triple negative breast cancer (TNBC) in collaboration with MSD.

The Company is also developing a diversified pre-clinical pipeline of selective Axl inhibitors including BGB149, anti-Axl monoclonal antibody.

For further information, please visit: www.bergenbio.com

About NSCLC
It is estimated that more than 220,000 new cases of lung cancer will be diagnosed in the US in 2017 and it is the leading cause of cancer death. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.

About TNBC
Breast cancer is the most common cancer in women – it is estimated that more than 250,000 new cases will be diagnosed in the US in 2017. 20% of breast cancers lack receptors for three common hormones (estrogen, progesterone and HER2) and are thus called triple-negative breast cancers (TNBC). Treatment options for TNBC are limited to intense chemotherapy, but despite therapy recurrences are frequent and aggressive. Consequently, novel treatment strategies for TNBC are of high need.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC.

 

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.

Please find the full financial report and presentation enclosed.

 

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.

 

 

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.

 

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

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

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.

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

 

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.
http://www.lmi.no/aktuelt-fra-lmi/2016/09/nordic-life-science-days-er-i-gang-i-stockholm

Trenger Norge en egen koordinator for livsvitenskap?

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

http://www.lmi.no/aktuelt-fra-lmi/2016/09/trenger-norge-en-egen-koordinator-for-livsvitenskap

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

 

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.

 

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.

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 

 

Targovax recruits the first patient in a trial with the oncolytic virus ONCOS-102 in malignant pleural mesothelioma

Oslo 1 July 2016: Targovax today announced that the first patient has been dosed in a phase Ib/II clinical trial evaluating ONCOS-102 for the treatment of malignant pleural mesothelioma (MPM), a rare type of cancer in the lining of the lung, in combination with pemetrexed and cisplatin.

 

“New therapies are needed to provide better care for patients with mesothelioma, a highly malignant cancer with poor prognosis” says Dr Magnus Jaderberg, CMO of Targovax. “This clinical trial will provide data to evaluate the efficacy and safety of ONCOS-102 in first and second line mesothelioma patients, and we hope that our immunotherapy can provide additional benefit to chemotherapy, the existing standard of care.,

 

“In addition, treating the first patient in the first oncolytic virus trial of the merged company is of course an exciting moment for Targovax and all its stakeholders” adds Dr Jaderberg.

 

The trial is a randomized phase I/II clinical trial of 30 patients, with a phase Ib safety lead-in cohort of six patients, in first line and second line MPM patients who are eligible for treatment with pemetrexed and cisplatin. The trial’s main objectives are determination of safety, immune activation at lesional level and in peripheral blood, clinical response and the correlation between clinical outcome and the immunological activation. Several investigational sites in Europe will participate in this study. In addition to this trial, Targovax plans to initiate three immunotherapy combination trials with ONCOS-102 and one with its RAS peptide vaccine TG02 during the second half of 2016.

 

Malignant mesothelioma is a rare type of cancer 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 only 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 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.

For further information, please contact:

 

Gunnar Gårdemyr, CEO
Phone: +46 73 083 77 79
Email: ggardemyr@targovax.com

 

Øystein Soug, CFO
Phone: +47 906 56 525
Email: oystein.soug@targovax.com

 

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.

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,

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 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

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

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
    Press release from Vaccibody
  • 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

More information about the BIA-grants: Forskningsrådet investerer en halv milliard i innovative bedrifter

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

 

600MNOK in seed capital funds

Oslo Cancer Cluster member Sarsia Seed and Tromsø-based Norinnova have been given the managment of two new national seed capital funds on MNOK 300 in total by the Norwegian government. The money will be matched by privat capital. Sarsia Seed invests in life science/biotech and energy companies, whilst Norinnova invests in research based industrial biotech companies, oil and gass, marine and aquaculture.

SarsiaSeed has invested in Oslo Cancer Cluster members Vaccibody, BerGen Bio, Apim Therapeutics and 19 other companies within biotech/energy. Watch a short presentation on SarsiaSeed here.

– We are pleased that Sarsia Seed is the manager of one of the two new seed funds. The biotech sector needs competent investors as Sarsia Seed, says Jónas Einarsson, CEO of Radium Hospital Research Foundation.

The new funds will probably make their first investements in Q2 2016.


 

In Norwegian – from Innovation Norway´s home page:

Nye forvaltere av landsdekkende såkornfond
Styret i Innovasjon Norge har i dag besluttet å gi Sarsia Seed Management i Bergen og Norinnova Forvaltning i Tromsø ansvaret for forvaltningen av to nye landsdekkende såkornfond. Fondene skal nå sørge for at frisk såkornkapital på til sammen 600 millioner kroner blir brukt til å skape utvikling i norske vekstbedrifter.

Samarbeid
– Norsk næringsliv er i omstilling. For å utvikle ny virksomhet trengs det egenkapital i såkornfasen. De nye såkornfondene skal bidra til det. Her samarbeider offentlig og privat kapital om å styrke satsingsvillige og innovative bedrifter over hele landet. Dette er viktig for utviklingen av et fremtidsrettet norsk næringsliv, sier administrerende direktør Anita Krohn Traaseth i Innovasjon Norge.

Fremtidens næringsliv
Regjeringen besluttet i vår opprettelsen av to nye landsdekkende såkornfond.
Fondene skal investere i unge, innovative bedrifter med internasjonalt vekstpotensial. Innovasjon Norge har nå valgt forvaltere til de nye fondene. Fondet i Bergen skal forvaltes av Sarsia Seed Management og vil særlig rette seg mot bransjer knyttet til life-science og energi. Fondet i Nord-Norge skal ledes av Norinnova Forvaltning i Tromsø, og som vil være spesielt rettet mot forskningsbaserte bedrifter innenfor industriell bioteknologi, olje og gass, marin sektor og akvakultur.
Hvert fond vil investere i 15 til 20 bedrifter, og skal drives p markedsmessige vilkår.

– Unge, innovative bedrifter skaper nye arbeidsplasser. Såkornfond bidrar med penger og kompetanse, slik at vi kan få enda flere vekstselskaper i Norge. Jeg håper og tror at investorer i hele landet vil være med på å bygge opp fremtidens næringsliv, sier næringsminister Monica Mæland.

Kompetanse og nettverk
De nye såkornfondene skal hovedsakelig konsentrere seg om prosjekter Norge, men de kan også investere i internasjonalt. Denne fleksibiliteten skal gi fondene bedre mulighet til å hente inn penger, kompetanse og nettverk fra miljøer utenfor Norge.

Gjennom såkornfondene avlaster staten private investorer for risiko. Målet er at investorene kan bruke mer tid og kompetanse på å utvikle nye bedrifter. De to nye såkornfondene vil være på minimum 300 millioner kroner. Staten deltar med 150 millioner kroner i hvert fond. Investorene må stille med minst samme beløp.

Forvalterne skal hente inn privat kapital i månedene fremover. De nye fondene vil trolig gjøre sine første investeringer sommeren 2016.

 

Lytix Biopharma, Vaccibody and Regencis selected for the venture session at DNB Healthcare Conference

The venture session at the DNB Healthcare Conference features three Oslo Cancer Cluster member companies: Lytix Biopharma, Vaccibody and Regencis. They will all present in session five: Therapeutics, that starts at 15:00. See below for the full program. 

The venture session is part of the DNB Healthcare Conference on December 2015. In paralell to the venture seesion, there will be presentations of listed companies that features several Oslo Cancer Cluster members as well. See information on this here.

Program:

Session one: Medical Devices
09:00-09:15
Hy5
09:15-09:30
Otivio
09:30-09:45
RemovAid
09:45-10:00
Biovotec

Session two: Ultrasound and imaging based medtech companies
10:00-10:15
IC Target
10:15-10:30
Respinor
10:30-10:45

Break

10:45-11:00
Sonitor

Session three: M-Health
11:00-11:15
Curaservice
11:15-11:30
Pattern Solutions
11:30-11:45
X Center
11:45-13:00

Lunch and DNB Health Care Prize

Session four: Diagnostics
13:00-13:15
CardiNor
13:15-13:30
Genetic Analysis
13:30-13:45
Lifecare
13:45-14:00
PreDiagnostics
14:00-14:15
Spinchip
14:15-14:30
Glucoset
14:30-14:45
Spiro Medical
14:45-15:00
Break

Session five: Therapeutics
15:00-15:15
Lytix Biopharma
15:15-15:30
Pharmasum Therapeutics
15:30-15:45
Regenics
15:45-16:00
Vaccibody

Vaccibody and Ultimovacs nominated to DNB HealthCare Prize on 1 MNOK

DNB wants to contribute to a growth industry in Norway and has established a healthcare prize for early stage healthcare companies within pharmaceuticals, biotech, medtech and diagnostics. Of the six nominated for the DNB HealthCare Prize on 1 MNOK, two of them are members of the Oslo Cancer Cluster: Vaccibody and Ultimovacs. The other nominees are: Spiro Medical, Glucoset, Picterus and Labrida.

The winner will be announced and given the prize money by Rune Bjerke, CEO of DNB at the DNB Healthcare Conference on December 15. Companies will be evaluated on their business potential, innovation capacity and ability to execute. The prize is NOK1m and the six finalists will each hold a six-minute pitch for the jury and the audience. You are invited to vote for your favourite candidate.

 

 

 

Targovax in agreement with Ludwig Cancer Research and the Cancer Research Institute (CRI)

Ludwig Cancer Research and the Cancer Research Institute (CRI) announced today an agreement with Oslo Cancer Cluster member Targovax to evaluate its experimental virotherapy, ONCOS-102, in early phase clinical trials testing the virotherapy in combination with other, potentially synergistic immunotherapies such as checkpoint inhibitors.

“We believe oncolytic virotherapy-in which engineered viruses are deployed against cancer cells-holds considerable promise, especially for boosting the efficacy and expanding the applicability of compatible immunotherapies,” said Jonathan Skipper, executive director of technology development at the Ludwig Institute for Cancer Research. “This kind of clinical research is precisely what our collaboration with CRI is all about, and certainly a key component of our mission to apply our life-changing science as quickly as possible to cancer patients everywhere.”

ONCOS-102 is an engineered human serotype 5 adenovirus optimized to induce systemic anti-tumor T cell response in cancer patients. A gene encoding granulocyte-macrophage colony stimulating factor (GM-CSF), which was originally discovered by Ludwig researchers in Melbourne, is inserted into the virus genome and expressed as the virus replicates in tumor cells.

“Our partnership with Targovax and Ludwig is an important step forward in efforts to discover and develop optimally effective immunotherapy treatment regimens,” said Adam Kolom, managing director of CRI’s Clinical Accelerator and venture fund that will support this trial. “This strategic partnership is the latest in a series of CRI-Ludwig collaborations with pharmaceutical companies to test novel combination treatments, and will enable us to explore an innovative new way to create a more favorable tumor microenvironment for an immune attack on cancer.”

“We are delighted about this partnership and what may come out of it. Targovax R&D will have access to the well-known expertise and network of CRI and Ludwig Cancer Research, which provides us with new opportunities for combinatorial research. The focus will be on mechanistic synergies with clinical impact combining ONCOS-102 with other immune therapies to the potential benefit of patient care in the future,” says Magnus Jaderberg, chief medical officer at Targovax.

 

About Ludwig Cancer Research

Ludwig Cancer Research is an international collaborative network of acclaimed scientists that has pioneered cancer research and landmark discovery for more than 40 years. Ludwig combines basic science with the ability to translate its discoveries and conduct clinical trials to accelerate the development of new cancer diagnostics and therapies. Since 1971, Ludwig has invested nearly $2.7 billion in life-changing science through the not-for-profit Ludwig Institute for Cancer Research and the six U.S.-based Ludwig Centers. To learn more, visit www.ludwigcancerresearch.org.

About the Cancer Research Institute

The Cancer Research Institute (CRI), established in 1953, is the world’s only non-profit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and cure cancer. Guided by a world-renowned Scientific Advisory Council that includes three Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $311 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. Learn more at www.cancerresearch.org.

 

About Targovax

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 is a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers and 20-30% of all cancers. Targovax works towards demonstrating that TG01 will prolong time to cancer progression, increase survival and improve safety and tolerability.

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 visit our website at www.targovax.com.

 

For further information, please contact:

Rachel Steinhardt

Vice President of Communications, Ludwig Institute for Cancer Research

rsteinhardt@licr.org or +1-212-450-1582

 

Brian Brewer

Director of Marketing and Communications, Cancer Research Institute

bbrewer@cancerresearch.org or +1-212-688-7515 x242

 

Gunnar Gårdemyr

Chief Executive Officer, Targovax

ggardemyr@targovax.com or +41 798 340 585

HealthCap opens office in Oslo Cancer Cluster Incubator

HealthCap, a leading life science venture capital firm, has opened office in the newly established incubator in the Oslo Cancer Cluster Innovation Park. HealthCap also becomes a member of the Oslo Cancer Cluster.

 

HealthCap recognizes the emerging life sciences industry in Norway. “The strong environment created in the dedicated oncology cluster, bringing together all parts of the oncology value chain at the world renowned Radiumhospitalet, holds promise to play an important role in the development of the next generations of oncology treatments. We look forward to take part in and contribute to this important endeavor”, says Björn Odlander, managing partner of HealthCap.

HealthCap has retained Ludvik Sandnes to supervise the Norwegian operations. Ludvik Sandnes is a special advisor to HealthCap and has more than 40 years of experience from international corporate finance and asset management. He is currently the chairman of the listed Norwegian oncology company Nordic Nanovector AS.

 

HealthCap will host a seminar at the Oslo Cancer Cluster Innovation Park on December 9th at 12.30.
Please sign up here, the program will be published shortly.

The CEO of Oslo Cancer Cluster and Chairman of the Board of Oslo Cancer Cluster Incubator, Ketil Widerberg says “We are extremely happy to have HealthCap on board both in the Oslo Cancer Cluster and in the Incubator. HealthCap´s track record of investing in life science is impressing, and their competence and network will be valuable for further building a viable oncology industry based on excellent cancer research at Norwegian academic institutions.”

HealthCap invests in companies developing targeted therapies for rare diseases, cancer and genetic diseases, among others. HealthCap was the lead investor in the Norwegian oncology company Algeta, which was acquired by Bayer for USD 2.9 bn, and is the largest shareholder in the Norwegian oncology companies Nordic Nanovector AS and Targovax AS.

Purely focused on oncology, the Oslo Cancer Cluster Innovation Park and Incubator, will ensure that bright ideas in the lab benefit cancer patients faster than today.

 

For more information, please contact:

Björn Odlander, managing partner HealthCap,  email: bjorn.odlander@healthcap.eu, phone: +46 8 442 58 50

Johan Christenson, partner HealthCap, email: johan.christenson@healthcap.eu, phone: +46 8 442 58 50

Ketil Widerberg, CEO Oslo Cancer Cluster and Chairman of the Board Oslo Cancer Cluster Incubator, email: kw@oslocancercluster.no, phone: +47 915 77 990

 

Facts:

HealthCap:
HealthCap is a leading European venture capital firm investing exclusively and globally in life sciences. A cornerstone of the strategy is to invest in companies developing therapeutic interventions that have the potential to significantly improve patient outcomes. HealthCap backs companies developing targeted therapies for rare diseases, orphan drugs, cancer and genetic diseases, among others. The HealthCap team of ten partners, five of whom are MD PhDs, has established its reputation as one of Europe’s preeminent life science specialists amongst VCs and entrepreneurs. See more at: www.healthcap.eu

 

Oslo Cancer Cluster
Oslo Cancer Cluster is a strong biotech cluster well positioned in the global oncology industry. The cluster is particularly strong in immuno-oncology and works to release the potential that lies within Norwegian oncology registries and bio banks. 70 members make up the cluster and represent the entire oncology value chain. www.oslocancercluster.no

 

Oslo Cancer Cluster Incubator
Oslo Cancer Cluster Incubator offers lab and office space to researchers and biotechs developing cancer treatments, as well as companies offering competence, services and an international network crucial to succeed in this globally competitive area. The incubator´s over all aim is to develop more companies based on excellent cancer research as well as to contribute to their success. Today, more than X companies are part of the incubator. www.occincubator.com

 

Oslo Cancer Cluster Innovation Park AS

Total space: 36 000 m²

Vision: The vision of the Oslo Cancer Cluster Innovation Park is to create Europe’s leading environment for education, research and industry within oncology, while also shortening the time it takes to develop new cancer medication and diagnostics.

Tenants: Oslo University Hospital, The Institute for Cancer Genetics and Informatics, Norwegian Cancer Registry, Oslo Cancer Cluster SA, Oslo Cancer Cluster Incubator AS, The Norwegian Radium Hospital Research Foundation, The Oslo Hospital Pharmacy, Ullern High School and leading Norwegian biotech companies such as Ultimovacs and PCI Biotech.

Owners: OBOS, Industrifinans, Radium Hospital Foundation, Utstillingsplassen Eiendom, Oslo Cancer Cluster and Oslo Cancer Cluster Incubator.

Opened officially August 24 2015 by the Prime Minister of Norway, Erna Solberg.

www.occinnovationpark.com

 

Oslo Cancer Cluster Incubator: Hottest bioincubator in the Nordics

According to The European Biotech News Website, Oslo Cancer Cluster Incubator is ranked as the hottest bioincubator in the Nordics as well as the 6th hottest bioincubator in Europe. The Top 10 ranking is subject to several criteria. You may read the whole list here.

Oslo Cancer Cluster Incubator just opened its premises in the Oslo Cancer Cluster Innovation Park August this year and is home to around 20 companies,  instituitons and consultants.

The incubator´s ultimate goal is to contribute to the succesful commercialisation of cancer research performed in Norway. This will provide patients with new cancer treatments and at the same time build a much needed knowledge based health industry in Norway.

 

DNB Health Care Conference

DNB Health Care Conference on December 15 features many of Oslo Cancer Cluster member companies. See more information on the program below and use this chance to build competence, broaden your professional network and gain insight into what lies ahead for the market in 2016. 

There will also be a parallel venture session, organised by DNB together with Oslo Medtech, Oslo Cancer Cluster and Nansen Neuro. The companies presenting here have not been selected yet.

DNB Health Care Conference: Invitation and agenda 2015

DNB Healthcare Prize 2015
DNB wants to contribute to a growth industry in Norway and has established a healthcare prize for early stage healthcare companies within pharmaceuticals, biotech, medtech and diagnostics. Companies will be evaluated on their business potential, innovation capacity and ability to execute.
The prize is NOK1m and the six finalists will each hold a six-minute pitch for the jury and the audience.
You are invited to vote for your favourite candidate.
Please join us and our CEO, Rune Bjerke, when we announce the winner of the DNB Healthcare Prize 2015.

Registration: www.meetmax.com/dnbhcc2015

The programme will feature company presentations and Q&A sessions, and institutional investors will have the opportunity to meet management in one-on-one or small group meetings.

Agenda:

08:30-09:00       Registration and Breakfast
09:00-09:30       BerGenBio, CEO Richard S. Godfrey
09:30-10:00       Targovax, CEO Gunnar Gårdemyr + CMO Magnus Jäderberg
10:00-10:30        Nordic Nanovector, CEO Luigi Costa
10:30-10:45        Coffee Break
10:45-11:15         Elekta, Director & Head of IR Johan Andersson
11:15-11:45          GenMab, SVP, IR & Communication Rachel Curtis Gravesen
11:45-12:15        Lunch
12:00-13:00       DNB Healthcare Prize 2015* (parallel session)
12:15-12:45        Medistim, CEO Kari Krogstad
12:45-13:15       Speed Presentations:
Serodus, CEO Eva Steiness
PCI Biotech, CEO Per Walday
Vistin Pharma, CEO Kjell-Erik Nordby
13:15-13:30       Coffee Break
13:30-13:55       Vitrolife, CEO Thomas Axelsson
13:55-14:20       Recipharm, TBA
14:20-14:45       Wilson, CEO Jonas Hansson
14:45-15:00       Coffee Break
15:00-15:25       Weifa, CEO Kathrine Gamborg Andreassen + CFO Simen Nyberg-Hansen
15:25-15:50       Bionor Pharma, CEO David Horn Solomon
15:50-16:15       Photocure, CEO Kjetil Hestdal
16:15                  Cocktail Reception

Only available for 1:1 meetings: Gentian, CEO Bård Sundrehagen
The agenda is subject to change

Oslo Cancer Cluster companies pitching at Norwegian Investment Forum

4 Oslo Cancer Cluster member companies will pitch at Norwegian Investment Forum during Oslo Innovation Week Thursday October 15th: Vaccibody/picture above/, Nordic Nanovector, Regenics and Phoenix Soloutions

Our companies will pitch during the Health & Life Science sessions at the forum, chaired by Kathrine Myhre, CEO Oslo Medtech. Norwegian Investments Forum is a full day event – but you may join the the Health & Life Science sessions FOR FREE – they are at 10:30 am, second at 2:10 pm. The event is at Forskningsparken in Oslo.

Read more and register to participate on www.norwegianinvestmentforum.no.  
If you enter code word #occ you’ll get 25% off the registration fee – this is for participating the whole day.

Nextera AS announces research collaboration with Johnson & Johnson Innovation

Nextera, a Norwegian biotechnology company focused on developing novel and highly disease-specific immunotherapies for autoimmune diseases, cancer and chronic infections announces today that it has entered into a research agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.  The Johnson & Johnson Innovation Centre in London facilitated the research agreement.

 

Under terms of the agreement, Nextera will, with use of its unique technology platform, undertake certain verification studies to determine the applicability of Nexteras technology platform within rheumatoid arthritis (RA). Janssen will fund the research program, and will have an option for an exclusive worldwide license to the Nextera technology platform within RA.

“This research agreement represents Nextera´s first collaboration with a global biopharmaceutical company. We believe that our unique technology platform can offer great benefits in the development of new and improved treatment modalities for patients with autoimmune diseases, cancer and chronic infections. Thus, we are very enthusiastic for the collaboration with Janssen, a world leader in innovative drug development, and the opportunity we now have within rheumatoid arthritis,” said Thomas Andersen, CEO of Nextera.

 

About Nextera 

Nextera is a privately owned Norwegian biotech company. Our approach is to manipulate the disease at the initiation of the escalating immune cascade by identifying and subsequently targeting the principal causative agent.  The core technology of the company is our phage display engine, which we apply in protein engineering and evolution of T cell receptors and MHC class II molecules. The technology is developed by Nexteras CSO, Dr. Geir Åge Løset who co-founded the company as a spin out from his work at the group of Professor Inger Sandlie and the Centre for Immune Regulation, University of Oslo. The main shareholders of Nextera are The Norwegian Radium Hospital Research Foundation and Birk Venture AS.

www.nextera.no

 

 

 K Teams Boston: 9-20 November, 2015.

Opportunity for Oslo Cancer Cluster SMB´s: K Teams is a two week, intensive entrepreneurial training program in Boston and Cambridge. It is a great way to get a company started in the US. Please go to the following link for more information: http://kendall-teams.com/

The team behind the program is a seasoned, experienced group who have helped others companies make a successful entry into the US.  Boston is one of the most vibrant medical technology and bio/pharma regions in the US.

For more info:

Ron Sutherland, Launch in US Alliance: +1 617-407-0722 // rsutherland@launchinus.com

Vaccibody with vaccination of first patient

Vaccibody AS announced today vaccination of the first patient in its multicentre trial VB C-01 – an exploratory, open-label, multicenter phase I/IIa study VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).

 

Patients will receive intramuscular vaccinations of VB10.16 at three different time points. Two different dosing schedules will be evaluated during the first phase of the study in patients diagnosed with CIN 2, the best vaccination schedule will then be evaluated in the second phase 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: We are pleased to announce commencement of patient treatment in this first clinical trial with Vaccibody’s lead product VB10.16. Surgery is currently the only available therapy to remove abnormal cervical lesions caused by human papillomavirus and thereby stop the progression to cervical cancer. We are hopeful that VB10.16 immunotherapy can help change this treatment paradigm by offering a safe and efficacious alternative in the form of a therapeutic HPV vaccine.

Principal investigator,  Prof. Dr. med. Karl Ulrich Petry, Department of Obstetrics & Gynaecology Klinikum Wolfsburg commented:  The scientific approach of this well designed clinical study offers the chance to get a thorough understanding on how patients respond to VB10.16 immunotherapy. The first dosing of a patient has just been performed successfully in our hospital . We are convinced that patients with CIN 2 and CIN 3 will be very motivated to participate in the study to test this therapeutic vaccination as it might offer a non-invasive treatment option avoiding the side effects associated with surgical excision of the affected tissue and potentially also cure the underlying HPV infection and prevent recurrence. Furthermore, VB10.16 could also protect from other HPV16 induced cancers.

 

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).

 

 

 

Inven2 with broad immuno-oncology portfolio

Oslo Cancer Cluster member Inven2 is the largest technology transfer company in the Nordic region and a leading actor within Life Science. Oslo University Hospital and the University of Oslo are pioneers in several areas of immunology and cell based cancer therapies. Due to this, Inven2 has a broad portfolio within immuno-oncology to offer.

Immuno-oncology is one of the hottest topics globally at the time. Cancer immunotherapy, as this field is also called, was voted the “Science breakthrough of the year for 2013″ and qualified as “one of the world’s top disrupters” by Goldman Sachs in 2013. Cancer immunotherapy was also the “hot-topic” at the 2014 American Association for Cancer (AACR) meeting where the various current approaches and strategies being advanced today were well represented.


Portfolio of both immuno-oncology therapies and methods

Ongoing innovation projects within immuno-oncology at Oslo University Hopsital and the University of Oslo counts 6 therapies and 8 different technologies/methods being explored. Please see a full list below:

Immune-Oncology-2015_01-print

 

If you want to know more about these projects, please contact Jonny Østensen, Vice President Technology: jonny.ostensen@inven2.com / +47 911 922 36

PCI Biotech signs research collaboration with top-10 large pharma company

Oslo Cancer Cluster member PCI Biotech has signed an agreement with an undisclosed top-10 large pharma company, with the aim to evaluate synergistic effects of the PCI technology with their therapeutic nucleic acid technology. Initially, the purpose of the pre-clinical research program is to determine whether PCI has the potential to enhance the therapeutic effect of their nucleic acid technology platform.

The current pre-clinical research agreement covers evaluation of technology compatibility and synergy based on in vitro studies. The costs related to the research collaboration will be covered by the pharma company, which is one of the global leaders in nucleic acid therapeutics. The companies will evaluate the data generated in this research collaboration and based on this explore the potential for a further partnership. The original evaluation period spans over 9 months, but may be further extended.

“I’m delighted to announce this research agreement with one of the largest pharma companies in the world. We believe that the PCI technology has the potential to play a role in the realisation of several new therapeutic modalities, including cancer immunotherapy and mRNA therapeutics. This agreement shows that external players share this view”. Per Walday, CEO.

 

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 internalization (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, 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 currently has a bile duct cancer program in phase I/II clinical development. Bile duct cancer is an orphan indication without any approved medicinal products and a high medical need for better local treatments. It is an indication well suited for PCI treatment, with easy light access for intraluminal surface illumination through routine endoscopic methods and an active generic drug (gemcitabine) significantly enhanced by PCI.

The company is also developing PCI as a CTL (Cytotoxic T Lymphocyte) induction technology for therapeutic and prophylactic vaccination. It has been demonstrated both in vivo and ex vivo that PCI significantly increases the number of activated antigen-specific CTLs by enhancing the MHC I antigen presentation of antigen presenting cells. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines.

PCI Biotech follows a strategy to create value by improving the effect both of existing cancer drugs and by realizing the large potential in new therapeutics, including therapeutic vaccines.

For more information visit: www.pcibiotech.com

PCI Biotech announces activation of Oslo University Hospital as a new clinical site

PCI Biotech has activated Oslo University Hospital as a new clinical site in the phase I/II study of Amphinex in patients with inoperable bile duct cancer, cholangiocarcinoma.

Principal Investigator at Oslo University Hospital, Dr. Svein Dueland, said: “Bile duct cancer is a devastating disease lacking good treatment options for a majority of the patients. PCI of gemcitabine with Amphinex is an innovative treatment concept that could potentially give significant local tumour response in these patients. I look forward to working on this study, which is well designed to demonstrate a potential clinical benefit of Amphinex induced PCI of gemcitabine in bile duct cancer patients.”

Per Walday, CEO of PCI Biotech, said: “I’m delighted with the activation of Oslo University Hospital as a contributing site for this study.  The PCI technology originates from this hospital and it will be a pleasure to work closely with these highly competent investigators to progress the study as quickly as possible. Bile duct cancer has a high need of new local treatment options and the specific attributes of the PCI technology fits well with this disease and its unmet medical need.”

 

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 internalization (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, 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 currently has a bile duct cancer program in phase I/II clinical development. Bile duct cancer is an orphan indication without any approved medicinal products and a high medical need for better local treatments. It is an indication well suited for PCI treatment, with easy light access for intraluminal surface illumination through routine endoscopic methods and an active generic drug (gemcitabine) significantly enhanced by PCI.

The company is also developing PCI as a CTL (Cytotoxic T Lymphocyte) induction technology for therapeutic and prophylactic vaccination. It has been demonstrated both in vivo and ex vivo that PCI significantly increases the number of activated antigen-specific CTLs by enhancing the MHC I antigen presentation of antigen presenting cells. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines.

PCI Biotech follows a strategy to create value by improving the effect both of existing cancer drugs and by realizing the large potential in new therapeutics, including therapeutic vaccines.

For more information visit: www.pcibiotech.com

NLSDays 2015: Meet international life science leaders and discuss the sector’s future at the Nordic region’s largest partnering meeting

NLSDays September 9-10 at Stockholm Waterfront is the Nordic region’s premier life science event. The global life science sector is undergoing major structural changes, and as part of a strong established hub, companies in Sweden and the Nordic countries are of great interest when international investors and corporations are looking for new partners.

The entire value chain from basic research to the introduction of new therapies is subject to transformation – not least due to rapid developments in digital health. Life science companies therefore need to find new ways to collaborate and fund their projects. Since the Nordic region offers a modern, competitive environment for academia and research companies alike, the region has become highly attractive for the global life science industry.

  • NLSDays has become the most important meeting place for global investors and corporations that are looking for new collaborations in the Nordic region. The event is on course for record numbers and deals such as the recent one between Alligator Bioscience and Janssen Biotech which illustrates that Swedish companies offer major value to partners, says Jonas Ekstrand, CEO SwedenBIO, the Swedish national life science industry organization which founded the event three years ago.

Overall, the life science sector is currently very active in the Nordic countries. For example, the Oslo Cancer Cluster Innovation Park, an investment of around 100 million Euros opens today (24 August). Furthermore, AstraZeneca recently announced a Euros 260 million investment in a new plant for bio-pharmaceutical production and from January 2014, 18 life science companies across all subsectors from medtech to biopharma have been listed on Nasdaq Nordic at a combined value of about Euros 250 million (Source Nasdaq). Furthermore, initiatives and companies in new areas such as personalized medicine, digital health and outcomes based provision are emerging at an accelerating pace.

During Nordic Life Science Days 2015 the main theme is “The New Value Chain”. The 2 day program covers several sessions in which international life science leaders will discuss strategies on how new partnerships can be established and how medical research and the life science industry in the Nordics can contribute.

Super Sessions from the program:

  • International Investors (9 September at 11.30 – 12.30)

International life science investors talk about their investment models and what they look for from entrepreneurs.

  • Personalized Healthcare – Matching Medicines to Patients (September 10 at 08:45 – 09-45)

How will big data and new diagnostic methods impact the future of medical research and treatment modalities? Listen to how the Digital Doctor Watson can revolutionize health care.

  • Oncology 2025 (10 September 11.30 – 12.30)

Immuno-oncology is hotter than ever and there is an ongoing competition between the big global companies to take on the most promising projects. Representatives from several of the major players talk about their strategies.

Currently, 800 delegates are registered for this year’s NLSDays, which is 33% more than at the corresponding time last year. This strongly indicate that the meeting will attract over 1,000 participants, outnumbering last year’s number of delegates.

The conference is organized September 9-10, 2015 at Stockholm Waterfront Congress Centre, Nils Ericssons Plan 4 in Stockholm. More info on www.nlsdays.com.

 

About NLSDays

Founded in 2012 the Nordic Life Science Days has grown rapidly to become the largest Nordic partnering conference for the global life science industry. In 2014, 890 delegates from 28 countries attended the meeting. The 580 companies attending offered 490 licensing opportunities in the partnering system and during the two days 1600 one-on-one meetings were scheduled. Among the investors and big pharma already registered for the meeting in September 2015 are AbbVie, Alexion, Almi Invest, Astellas, AstraZeneca, Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Cadila Pharma, Johnson & Johnson, HealthCap, Industrifonden, Karolinska Development, Merck-MSD, Novartis, Pfizer, Pierre Fabre, P.U.LS. AB, Recipharm, Roche, Seventure Partners, SR-One.

In addition to partnering, NLSDays also offers an exhibition and a seminar program with 10 super session and four topic specific workshops. Speakers include senior representatives from the global life science companies, investors, and academic leaders who will all share their expertise and views for the future.

About SwedenBIO

SwedenBIO who is the founder and organizer of the Nordic Life Science Days is the Swedish life science industry organization. Our nearly 200 members operate across all sub-sectors from pharmaceutical, biotechnology, medical technology to diagnostics. SwedenBIO serves to the benefit the entire life science industry in Sweden and is a member-driven, private, non-profit organization. The main objective is to improve the conditions for the life science industry for the benefit of industry growth and business development.

 

Oslo Cancer Cluster Incubator filling up

12 companies will have offices and lab in Oslo Cancer Cluster Incubator from August on. Bjørn Klem, General Manager of the Incubator, anticipates full house by January 2016.

– If each and every company we have given a quote so far, accepts, we actually are over booked. As of now, we have a good mix of companies. We look forward to have even more start-ups as a result of the activity in Oslo Cancer Cluster Innovation Park and the increased focus on commersialization of cancer research the building represents, says Klem.

The companies will start moving into the Incubator the first week of August, and from then on it is business 24/7. The Oslo Cancer Cluster Managament Team will support the incubator companies with competence within business development, communication, partnering, investor contacts and so on thorugh Oslo Cancer Cluster´s extensive network.

 

Overview Oslo Cancer Cluster Incubator companies as of mid-June:
See profiles of the companies on the Oslo Cancer Cluster Incubator website

  • DNB
  • Curida
  • Intersint
  • Ultimovacs
  • Inven2
  • Lifandis
  • Medivir
  • Pharmalink
  • Normetrix
  • Lytix Biopharma
  • Radium Hospital Research Foundation
  • Oslo Cancer Cluster Management Team

 

 

Targovax and Oncos Therapeutics join forces to create a Nordic leader within immuno-oncology

Targovax and Oncos Therapeutics join forces to create a Nordic leader within immuno-oncology and contemplate a private placement of NOK 125–150 million to fund the combined business

Tagovax has entered into an agreement with the shareholders of Oncos Therapeutics to acquire the shares of Oncos with settlement in Targovax shares. The combined company with multiple assets in research and development will be a Nordic leader within immuno-oncology. The new company will have a strong senior management team and be financially backed by reputable institutional investors with sector specialist HealthCap as the largest shareholder.

To fund the combined company, Targovax contemplates to raise NOK 125-150 million through a private placement directed towards Norwegian and international investors, and has already received indications from leading institutional investors for a substantial amount, including but not limited to a NOK 26 million commitment from HealthCap, NOK 25 million from Datum Invest AS and NOK 5 million from the Norwegian Radium Hospital Research Foundation. In addition, the Private Placement is directed towards the 24 employees of Targovax and Oncos and their respective subsidiaries, and companies controlled by any such employees.

 

Rationale for the Transaction

Targovax and Oncos—based in Oslo and Helsinki, respectively—are both clinical-stage biotechnology companies with broad pipelines addressing the immuno-oncology market, which currently is quite modest, but is expected to grow to USD 30-35 billion over the next decade.

By combining Targovax and Oncos, a larger and more visible Nordic immuno-oncology player with a more extensive portfolio will be created. Furthermore, the combination of two highly competent and complementary organizations will promote more efficient execution and accelerate the development of ongoing and future programs.

Clinical results to date confirm the safety and the mechanisms of action for both technology platforms. Safety data from Targovax and Oncos programs have been collected on approximately 250 and 290 patients, respectively. Both companies have completed Phase I and are now in Phase II development, or about to enter Phase II development, with broad pipelines, and both utilize an immuno-oncology approach that is highly suitable for combination therapies. Clinical programs in several indications will provide increased opportunities for newsflow over the next 18 months.

“The combination of Targovax and Oncos creates a major Nordic player within immuno-oncology. We will have a wide array of programs in the pipeline and multiple shots at goal. The companies’ complementary technologies will provide a unique platform for the development of cutting-edge immunotherapies, and we will have a higher chance of success, thus offering investors an even more compelling opportunity. I am excited to lead an organization of highly skilled professionals with deep industry experience”, said Gunnar Gårdemyr, Chief Executive Officer of Targovax.

 

Senior Executives and Board of Directors

After the Transaction, the highly experienced senior management team will consist of the following members:

  • Gunnar Gårdemyr (Chief Executive Officer) has more than 30 years of international experience in the pharmaceutical and biotech industry from companies such as Nycomed and Takeda
  • Magnus Jäderberg (Chief Medical Officer) has more than 25 years of experience from R&D functions and was previously CMO at Bristol-Myers Squibb (Europe)
  • Øystein Soug (Chief Financial Officer) has prior experience as the Chief Financial Officer of Algeta and in positions with the Orkla Group
  • Jon Amund Eriksen (Chief Operating Officer) was the co-founder of Targovax and has 35 years of R&D experience in the pharmaceutical and biotech industry, of which 25 years were within immuno-oncology

After the Transaction, the proposed Board of Directors will consist of the following members:

  • Jónas Einarsson (Chairman of the Board of Directors), Chief Executive Officer of the Norwegian Radium Hospital Research Foundation
  • Johan Christenson (Board Member), Partner at HealthCap
  • Per Samuelsson (Board Member), Partner at HealthCap
  • Lars Lund-Roland (Board Member), CEO of Bringwell, with more than 25 years of experience from various executive positions within Merck
  • Bente-Lill Romøren (Board Member), Board Member of the Norwegian Radium Hospital Research Foundation and Chairman of Farmastat and Photocure
  • Robert Burns (Board Member), Chairman of Haemostatix, previously CEO of 4-Antibody, Affitech, and Celldex Therapeutics, all three being early companies in the immuno-oncology space

 

The Transaction and the Private Placement

Targovax has entered into an agreement with the shareholders of Oncos to acquire the shares of Oncos with settlement in Targovax shares. After completion of the Transaction, the shareholders of Oncos will own 50 per cent of the combined company. The shareholders of Oncos will in aggregate receive 9,429,404 new Targovax shares that are to be issued at NOK 25.00 per share.

Targovax further contemplates to raise NOK 125-150 million in equity through the Private Placement to fund the combined business. The subscription price in the Private Placement is set to NOK 25.00 per share. The application period commences today on 11 June 2015 at 09:00 (CET) and will close on 19 June 2014 at 16:00 hours (CET). The Company, together with the Joint Global Coordinators (as defined below), reserve the right to close the application period at any time at their sole discretion, at short notice. The minimum order size and allocation in the Private Placement has been set to offer shares worth the NOK or share equivalent of EUR 100,000. The minimum order size and allocation amount does not apply to Eligible Employees. The allocation of shares will be determined at the end of the application period. The final allocation will be made at the Board’s sole discretion.

An updated presentation of the Company and the Transaction is available on the Company’s web site, www.targovax.com.

ABG Sundal Collier, Arctic Securities and DNB Markets are acting as Joint Global Coordinators and Bookrunners for the Private Placement (the “Joint Global Coordinators”). DNB Markets has acted as financial adviser to Targovax in relation to the Transaction. Guggenheim Securities, LLC has acted as financial adviser to Oncos in relation to the Transaction.

 

About Targovax
Targovax is an Oslo-area based global biotechnology company, dedicated to the design and development of immunotherapy vaccines for patients with RAS-mutated cancers. Established in 2010 by the inventors of this RAS-targeted technology and the Norwegian Radium Hospital Research Foundation in Oslo, Targovax has over 25 years of direct experience and has seen more than 250 patients treated with this promising technology.

 

About Oncos
Oncos is a privately funded clinical-stage biotechnology company focused on the development and commercialization of targeted cancer immunotherapy. Oncos’ product candidates induce a tailored response by the immune system directed at each patient’s unique cancer cells. Oncos’ lead product candidate, ONCOS-102, has successfully completed Phase I clinical studies. Additionally, a promising pipeline has been developed using Oncos’ patented adenovirus-based cancer immunotherapy platform, for the treatment of several cancer types, including soft tissue sarcoma, ovarian cancer and mesothelioma. The novel immunotherapy platform is based on engineered oncolytic viruses armed with potent immune-stimulating transgenes.

 

 

Vaccibody aquaculture collaboration granted 10 MNOK

The research collaboration “New Targeting Vaccines for Sustainable Aquaculture” has received a grant of NOK 10 Million through the Norwegian Research Council’s program Biotek2021. Oslo Cancer Cluster member Vaccibody is a partner in the project together with The Norwegian Veterinary Institute, Pharmaq AS, Kjeller Innovasjon and Kongla AS. 

 

The purpose of the project is to develop customized targeted fish vaccines based on the Vaccibody principle.  The NOK 10 million will be awarded over 3 years.

Tom Pike, Chairman and Acting CEO of Vaccibody, commented: “We are very pleased to be a part of this collaboration and for the funding it will receive from the Norwegian Research Council .The fish farming industry are facing a number of challenges related to infections and the Vaccibody technology is well suited to attack these challenges in a sustainable manner, without the global issues associated with antibiotics. We are also proud to work with a consortium of well qualified partners.  The project fits well with Vaccibody’s strategy to develop its technology platform together with partners while focusing the main share of its internal resources on the development of VB10.16, a therapeutic DNA vaccine to treat precancerous lesions of the cervix currently entering Phase I/IIa.”

 

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 drug candidate VB10.16 is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The company is currently entering it’s first-in-man study that will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

NLS Days – time to sign up

Oslo Cancer Cluster is one of the supporting organizations for this years Nordic Life Science Days in Stockholm. Members of the cluster benefit from special rates on participation plus we host an Oncology 2025 Super Session.

In collaboration with LMI, Nansen Neuroscience Network and other healthcare industry actors in Norway, Oslo Cancer Cluster will attend NLSDays to promote Norwegian Healthcare Industry and the cluster members.

Questions regarding the conference may be directed to Jutta Heix, International Advisor or Elisabeth Kirkeng Andersen, Head of Communicaton.

Read the latest newsletter from NLSDays 2015 below or online

The 3rd annual Nordic Life Science Days partnering conference will take place September 9–10 in Stockholm, Sweden, at the Waterfront. NLSDays Super Sessions and Workshops feature top industry leaders and executives speaking on relevant trends to industry decision makers.


Already 50+ Company Presentations confirmed

Presenting at NLSDays is the perfect chance to increase your visibility and attract more partners. Pitch your company’s profile, strategy and objectives to a global audience. Be seen by BD executives, investors, analysts, media and get more activity in partneringONE®. Still a few 6mn and 12mn available slots, don’t miss the opportunity to book your presentation when registering.


Already 50+ Exhibitors confirmed
NLSDays brings hundreds of Life Science Industry leaders from 30+ countries together for 2 days of intensive networking. As an exhibitor, you will reach high-level executives and influential decision makers who come to NLSDays to meet with new players in the industry and initiate partnerships. Still a few 4sqm, 6sqm and 9sqm available stands, don’t miss the opportunity to book yours now.


Oncology 2025 Super Session
Hosted by Oslo Cancer Cluster. Oncology is at the forefront of realizing the promises of precision medicine. Huge and complex datasets are exploited for novel drugs devolpment as well as for informed and real-time care decisions. Emerging cancer immunotherapies represent a paradigm shift for cancer treatment triggening a global R&D race and novel partnerships. Furthermore, the convergence of the genetics and digital revolution creates novel types of products, companies and growth opportunities transforming the sector.


International Investors Super Session

Hosted by Business Sweden, co-hosted by Industrifonden and HealthCap. Meet the investors actively investing in European Life Sciences companies. What are they looking for? What are the learnings in biotech and medtech investing over the past decade? How are these learnings being applied in current investments decisions? How is the financial climate in Life Sciences today?


Member of a supporting organization?
Since Oslo  Cancer Cluster is a supporting organization, members get a discount. Send an e-mail to Elisabeth Kirkeng Andersen, Head of Communicaton to get the Promotion Code and benefit from discount on all registration fees. Remember that Regular Rate registration period ends on June 30, 2015.


Interested in
sponsoring, exhibiting, presenting ? Contact: Olivier Duchamp, olivier.duchamp@bionordic.org

Large Oslo Cancer Cluster delegation to BIO2015

More than 15 Oslo Cancer Cluster members will be present at BIO2015 in Philadelphia in June. BIO is the world´s largest biotech fair and a very important partnering event for the cluster.

The companies attending BIO from the cluster are: BerGenBio, Lifandis, Lytix Biopharma, Nextera, Nordic Nanovector, Normetrix, Pharmalink Oncology, Inven2, BTO, Targovax, Ultimovacs, Vaccibody, The Radium Hospital Research Foundation, Chiltern and DNB Healthcare.

International Advisor Jutta Heix will represent Oslo Cancer Cluster Managment Team.

International Cancer Cluster Showcase
Oslo Cancer Cluster will also this year arrange International Cancer Cluster Showcase at BIO, together with other world-leading cancer clusters.  New partners are OBN, UK with a strong international investor network and the Wistar Institute from Philadelphia as local partner.

Member companies pitching at the International Cancer Cluster Showcase are Inven2, Ultimovacs and Nordic Nanovector.

Inven2, Norway´s largest TTO, will pitch their portfolio of early projects which is really strong in immuno-oncology, Ultimovacs will present the clinical development of their universal cancer vaccine, whilst Nordic Nanovector will present the clinical development of their targeted radiopharmaceutical treatment of lymphoma. Nordic Nanovector went public this March with one of the biggest IPO´s in European biotech so far this year.

We are very proud to have two Oslo Cancer Cluster members sponsoring the International Cancer Cluster Showcase this year: Chiltern and DNB Healthcare.

DNB Healthcare is also hosting a special healthcare event in New York on June 12 prior to BIO.

 

Ultimovacs, Inven2 and Nordic Nanovector will present at ICCS

Oslo Cancer Cluster will for the 4th 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 Inven2, Ultimovacs and Nordic Nanovector:

  • Ultimovacs will present the clinical development of their universal cancer vaccine
  • Inven2, Norway´s largest TTO, will pitch highlights from their portfolio which is particularly strong in immuno-oncology
  • Nordic Nanovector will present their lead clinical-stage product opportunity Betalutin™, the first in a new class of Antibody-Radionuclide-Conjugates (ARCs).Nordic Nanovector went public this March with one of the biggest IPO´s in European biotech so far this year.

Below you may find some more information on this years edition of ICCS and BIO2015.

International Cancer Cluster Showcase 2015, June 15th, 2015 – Philadelphia Convention Center

General BIO Info:

  • BIO 2015 takes place in Philadelphia. From what we hear the hotels are filling up, so be sure to book your housing soon if you are attending
  • 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

 

 

PCI Biotech starts collaboration in siRNA therapeutics

PCI Biotech, a Norwegian cancer focused biopharmaceutical company, announced that it is initiating a pre-clinical research collaboration with RXi Pharmaceuticals (NASDAQ: RXII). RXi is an American biotechnology company focused on discovering and developing innovative therapeutics, that address high-unmet medical needs primarily in the area of dermatology and ophthalmology.

The partnership is governed by a pre-clinical research collaboration agreement. Initially, the purpose of the pre-clinical research collaboration is to utilize the companies’ complementary scientific platforms to explore potential synergies.

In brief the pre-clinical research collaboration will evaluate technology compatibility based on in vitro and in vivo studies. The costs related to the research collaboration will be covered by each company separately. The companies will evaluate results achieved from this research collaboration and then explore the potential for a closer collaboration.

Both companies will retain exclusive ownership rights to existing registered intellectual property. However, any inventions arising from the collaboration will be jointly owned by the companies.

 

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 internalization (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, the PCI technology works by inducing triggered endosomal release and may be used to unlock the true therapeutic potential of a wide array of modalities, such as small molecules, ADCs and siRNA. Two programs are currently in clinical development in patient populations with a high unmet medical need; recurrent head and neck cancer (phase II) and bile duct cancer (phase I/II).

The company is also developing PCI as a CTL induction technology for therapeutic and prophylactic vaccination. It has been demonstrated both in vivo and ex vivo that PCI significantly increases the number of activated antigen-specific CTLs (Cytotoxic T Lymphocytes) by enhancing the MHC I antigen presentation of antigen presenting cells. When applied more specifically to the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines. PCI Biotech follows a strategy to create value by improving the effect both of existing cancer drugs and by realizing the large potential in new therapeutics, including therapeutic vaccines.

www.pcibiotech.com

Nordic Nanovector raised MNOK 500

Oslo, 20 March 2015. Nordic Nanovector ASA (“Nordic Nanovector”, the “Company”, OSE ticker code: “NANO”) announces the successful completion of the bookbuilding period for its initial public offering (the “Offering”), which was multiple times oversubscribed for the full amount of the Offering (including over-allotment) throughout the narrowed indicative price range.

In summary:
• Nordic Nanovector will issue 15,625,000 new shares in connection with the Offering, raising gross proceeds of NOK 500 million. There will in total be 42,175,291 shares in issue following the issuance of the new shares.
• The Managers (as defined below) have over-allotted 2,343,750 shares, representing 15% of the number of shares issued and sold in the Offering before over-allotments, and exercised their option to borrow an equal number of shares from HealthCap VI L.P. for the purpose of covering such over-allotments.

• The shares are priced at NOK 32 per share. The price implies a market capitalisation of Nordic Nanovector of approximately NOK 1,350 million (excluding shares that may be issued in connection with the over-allotment).

• Trading of the shares in Nordic Nanovector on the Oslo Stock Exchange will commence on 23 March 2015.

Approximately 91% of the shares in the Offering have been allocated to investors in the institutional offering and approximately 9% of the shares have been allocated to investors in the retail offering. Following the Offering, Nordic Nanovector is expected to have approximately 1,200 shareholders.

Luigi Costa, CEO of Nordic Nanovector, said: “We are delighted with the positive support Nordic Nanovector and its team has received by domestic and international investors. This has enabled us to upsize our IPO and raise additional funds to advance the development of Betalutin™, our first-in-class Antibody-Radionuclide-Conjugate, beyond the first regulatory submission planned in 2017”.

Luigi Costa continued: “Betalutin™ is specifically designed to deliver better treatment outcomes for patients with non-Hodgkin lymphoma by improving and complementing current therapy options. Betalutin™ targets CD37, a different antigen compared to standard CD20-targeted therapies with a short-range radiotherapy effecting tumour cell death while minimizing exposure to healthy cells. Based on this mechanism of action and promising clinical results to date, we have designed a robust development plan through to commercialisation.”

Notifications of allocated shares and the corresponding amount to be paid by investors are expected to be communicated to investors today (20 March 2015). Investors having access to investor services through their VPS account manager will be able to check the number of shares allocated to them from approximately 09:00 hours (CET) on 20 March 2015. The Managers may also be contacted for information regarding allocations.

The Company has granted the Managers an over-allotment option, exercisable by ABG Sundal Collier as stabilisation manager within 30 days from the first day of listing to cover over-allotments and short positions in connection with the Offering. A separate disclosure will be issued by the stabilisation manager regarding the over-allotment and stabilisation activities.
ABG Sundal Collier and DNB Markets, a part of DNB Bank ASA, are acting as Joint Global Coordinators for the Offering and ABG Sundal Collier, Carnegie and DNB Markets are acting as Joint Bookrunners for the Offering. The Joint Global Coordinators and Joint Bookrunners are herein referred to as the “Managers”.

 

About Nordic Nanovector

Nordic Nanovector is a biotech company focusing on the development and commercialization 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-Radio-Conjugates (ARCs), designed to improve upon and complement current options for the treatment of Non-Hodgkin’s 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 tumor-seeking anti-CD37 antibody conjugated to low intensity radionuclide (Lutetium 177). It has shown promising efficacy in Phase 1 studies in a difficult-to-treat NHL patient population and as well as a very favourable tolerability. Betalutin™ is fast advancing through clinical development and with first approval anticipated in 2018.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialization of Betalutin™ in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat a number of select cancer indications.

 

 

NLSDays 2015 – Early Bird through March 31

Oslo Cancer Cluster is one of the supporting organizations for this years Nordic Life Science Days in Stockholm, as we were last year. This means that members of the cluster benefit from special rates on participation. Through March 31 you may also get early-bird discount.

In collaboration with other healthcare industry actors in Norway, Oslo Cancer Cluster will have a stand at NLSDays to promote Norwegian Healthcare Industry and the cluster members.

Questions regarding this conference may be directed to Jutta Heix, International advisor or Elisabeth Kirkeng Andersen, Head of Communicaton.

Read the latest newsletter from NLSDays 2015 below.

 

Why registering now?
Benefit from our Early Bird rates by registering before March 31st, 2015. Book and secure your company presentation slot when registering.

Benefit from an exclusive discount on all NLSDays’ registration rates. Please contact your organization to get your promotion code.

 

Why attending NLSDays 2015?

NLSDays annually attracts the best from pharma, biotech, medtech and finance the Nordic region has to offer for two days of intense networking. NLSDays’ Super Sessions, topical workshops and vibrant exhibition along with thousands of prescheduled face-to-face meetings make this event the place to be for companies across the Life Science value chain to meet and do business.

Attend NLSDays and take advantage of the opportunity for more partnering meetings in two days than in the rest of the year.

Based on attendance at previous events, NLSDays 2015 will bring together more than 1000 executives from biotechnology, medtech, pharmaceutical and finance companies from the Nordic region and from around the world, who will engage in some 2,000+ face-to-face meetings.

 

Why presenting at NLSDays 2015?

Presenting at NLSDays gives you a chance to increase your visibility and attract more potential partners. Pitch your company’s profile, pipeline and strategy to a selected audience representing over 30 countries. Be visible by business development executives, investors, media, and increase your activity in the partneringONE platform.

NB: Company presenters receive much more requests and schedule more meetings than non-presenting companies! Presenting companies are also spotlighted in NLSDays marketing material leading up to the event, as well as onsite.
Don’t miss the opportunity to book your presentation slot when registering.

Benefit from Early Bird rate on Company Presentation fees through March 31, 2015.

 

Why exhibiting at NLSDays?

The 2015 NLSDays Exhibition reflects our 2015 manifesto: “The Life Science Value Chain”.

Regional and country pavilions, from the Nordic Region and Europe, will showcase and host many companies from their regions or countries. Pharma, biotech, medtech and servives providers will join NLSDays exhibition as well.
About partneringONE™, the leading conference networking solution

partneringONE™ powered by EBD Group increase your ROI at the Nordic Life Science Days conference, reduce your overall business development costs and enhance your partnering effectiveness before, during and after the event. partneringONE allows you to:

• Search companies to source potential collaborations and funding opportunities

• Communicate directly with potential investors and/or partners

• Pre-schedule 30-minute face-to-face meetings to be organized onsite.

 

 

 

Targovax appoints former Algeta-CFO

Mr. Øystein Soug, has been the CFO of the late-stage oncology biotech company Algeta ASA since 2008, building up the functions of Finance, IR, Compliance, IT and HR. During Mr. Soug’s period at Algeta, the company raised USD 200m capital, launched Xofigo, established production and sales in the USA, partnered with and was acquired by Bayer AG. 

Gunnar Gårdemyr, CEO of Targovax, says “I am excited to welcome Øystein Soug to Targovax. With Øystein in place we are well positioned to move our products through the important Proof of Concept phase. Øystein’s recent experience from the successful financing and sub-sequent sale of Algeta to Bayer will be important to develop Targovax further.”

Before 2008, Mr. Soug was with the Norwegian Orkla group, holding two functions; first as project manager in Orkla’s Corporate Development M&A team and later as the CFO of SladCo, the Russian operations of Orkla. Prior to Orkla, Mr. Soug spent five years in banking. He has 17 years’ experience in international finance and corporate development. In addition, he has served as Deputy Chairman and Director of Bionor Pharma ASA since 2013.

Mr. Soug has an MSc in Economics and Finance and a Master of International Management (CEMS) both from the University of St Gallen in Switzerland.

Facts:
Targovax
Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccines based on pioneering research at the Norwegian Radium Hospital and Norsk Hydro. Mutation of RAS is an early mutation in the transformation of a normal cell into a cancer cell.

Lead candidate TG01 educates the body’s immune system to recognize and kill cancer cells with RAS mutations. TG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase II trials in operated pancreatic cancer. The company is located in Lysaker, close to Oslo, Norway.

 

Immuno- oncology / Cancer vaccines
The Norwegian cancer research community has been in the forefront of understanding the mechanisms for immuno-oncology and cancer vaccines. A cancer vaccine educates the body’s immune system to recognize and kill the cancer cells. The TG01 vaccine is therapeutic and is given as treatment to patients after surgery of cancer patients, to prevent relapse.

 

Pancreas cancer and other RAS-mutated cancer forms
Pancreatic cancer is a disease affecting 116 000 patients each year in EU and USA, and approximately 690 persons each year in Norway. Approx 15-20% of these are discovered at an early stage and are operable. The mortality is high, and the prognosis for these patients has been more or less unchanged the last 30 years. Approximately 80-90% of patients with pancreatic cancer have RAS mutations in the cancer cells.

RAS mutations occur in approx. 20% of all cancer cases, and are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.

 


Oslo, 26. februar 2015 Pressemelding no 3 -2015:

Targovax melder med stor tilfredshet at Øystein Soug er selskapets nye CFO fra 1. juni 2015.

Øystein Soug har vært Chief Financial Officer i kreft-biotekselskapet Algeta ASA siden 2008, der han bygde opp funksjonene for finans, IR, virksomhetsstyring, IT og HR. I løpet av Sougs periode i Algeta, hentet selskapet inn USD 200 millioner i kapital, lanserte Xofigo, etablerte produksjon og salg i USA og inngikk samarbeid og ble kjøpt opp av Bayer AG.

Soug hadde før 2008 to funksjoner i den norske Orkla-gruppen, først som prosjektleder i Orklas Corporate Development M&A team, og deretter som CFO i SladCo, den russiske delen av Orkla. Før Orkla var Øystein Soug fem år i bank. Han har 17 års erfaring fra internasjonal finans og selskapsutvikling. I tillegg har han vært nestleder i styret og styremedlem i Bionor Pharma ASA siden 2013.

Øystein Soug har en MSc i Økonomi og Finans og en Master i Internasjonal Ledelse (CEMS), begge fra Universitetet i St Gallen i Sveits.

Gunnar Gårdemyr, CEO i Targovax sier “Jeg er glad for å kunne ønske Øystein Soug velkommen til Targovax. Med Øystein på plass, er vi godt posisjonert for å utvikle produktene våre gjennom den viktige Proof of Concept-fasen. Øysteins nylige erfaring fra suksessfull finansiering og etterfølgende salg av Algeta til Bayer vil være viktig for å utvikle Targovax videre.»

Kontakt:

Targovax Gunnar Gårdemyr, Chief Executive Officer, mob: E-mail: ggardemyr@targovax.com

Jonas Einarsson, Chairman of the Board, mob: (+47) 48 09 63 55 E-mail: je@radforsk.no

Fakta: Targovax

Targovax ble etablert i oktober 2010 for å utvikle immunterapi i form av terapeutiske kreftvaksiner, basert på pionérforskning ved OUS Radiumhospitalet og Norsk Hydro. Mutasjoner i RAS forstyrrer normal celledeling, og bidrar til utvikling av kreftceller og svulster. Første legemiddel under utvikling, TG01, lærer opp kroppens immunsystem til å gjenkjenne og drepe kreftceller med RAS-mutasjoner. TG01 har Orphan Drug Status for bukspyttkjertelkreft i EU og USA, og er nå i fase II klinisk utvikling innen operabel bukspyttkjertelkreft. Selskapet er lokalisert på Lysaker utenfor Oslo.

Immuno-onkologi / kreftvaksiner

Det norske kreftforskningsmiljøet har vært i forskningsfronten når det gjelder å forstå mekanismene for immuno-onkologi/immunterapi og kreftvaksiner. En kreftvaksine lærer opp kroppens immunsystem til å gjenkjenne og drepe kreftcellene. TG01 er terapeutisk, den gis som behandling til pasienter etter kirurgi, for å forhindre tilbakefall.

Bukspyttkjertelkreft og andre RAS-muterte kreftformer.

Bukspyttkjertelkreft er en sykdom som rammer 116 000 pasienter hvert år i EU og USA, og ca 690 pasienter årlig i Norge. Ca 15-20% av disse avdekkes på et tidlig stadium og kan opereres. Dødeligheten er høy, og prognosen for disse pasientene har vært mer eller mindre uendret de siste 30 år. Ca 80-90% av pasienter med bukspyttkjertelkreft har RAS-mutasjoner i kreftcellene.

RAS-mutasjoner forekommer i ca 20% av alle krefttilfeller, også ofte i tykktarmskreft, ikke-småcellet lungekreft og andre kreftformer. Pasienter med RAS – mutasjoner innen disse sykdommene har vist seg å være vanskelig å behandle med dagens tilgjengelige medisiner, og det er et stort udekket medisinsk behov.

– See more at: http://www.noodls.com/viewNoodl/27052320/targovax-as/trvx-targovax-appoints-216ystein-soug-as-new-cfo#sthash.zygqEXIj.dpuf

Partnership4Life – oncology session and opportunity to do 1:1 meetings

February 12, LMI, DNB Healthcare, AbbVie, Novartis and Pfizer hosts a one day seminar called A partnership for life in 2015 – How to develop a strong Norwegian biotechnology and health industry sector?

Oslo Cancer Cluster is well represented this day; we will host an oncology session and Jónas Einarsson, CEO Radium Hospital Research Foundation, will give a spech on Norwegian biotech and health industry from words to action. There will also be opportunity to do 1: 1 meetings with potential partners.

Global biotech and pharmaceutical industry, academia, financial institutions, investors, hospitals and politicians are invited to participate.

The program is twofold. Before lunch there will be an overarching focus with introductions and a panel discussion on this subject. After lunch there will be shorter seminars where different actors will exchange information and experiences.

Finally, it is allocated time for the 1: 1 meetings between potential partners. The day ends with dinner at Cafe Christiania in Oslo.

  • Register her
  • Register for 1:1 meetings by sending e-mail to monica@lmi.no to be put in contact with the international companies

PROGRAM
Forskningsparken, 12 February 2015

8:30 to 9:00 Registration and refreshments

9:00 to 9:15 Opening

9:15 to 9:30 Travelogue from Silicon Valley
Alexander Woxen, entrepreneur and investor

9:30 to 10:00 Introduction by Ministry of Economics
Dilek Ayhan, Secretary in the Ministry of Industry

10:00 to 10:15 Norwegian biotech and health industry from words to action
Jonas Einarsson, CEO Radium Hospital Research Foundation

10:15 to 11:30 Plenary Discussion: “How do we build a strong Norwegian biotech and health industry sector.”
Else-May Botten (AP)
Harald Tom Nesvik (FRP)
Trine Skei Grande (Left)
Karita Bekkemellem (LMI)
Benedicte Bakke (DNB)
Alexander Woxen (Investor)
Sander Tufte (Research)
Thomas Ramdahl (Bayer)

13.00 to 14.30 Parallel Sessions on 1 Public-private research collaborations and 2 Access to capital

14.30 to 15.00 Coffee and refreshments

15.00 to 16.30 Exchange of research ideas and focus. Introduction of national and international companies about their research focus. Parallel Sessions: Neuroscience and Oncology.

Session: Oncology

  • Elisabeth Kirkeng Andersen, Head of Communication in Oslo Cancer Cluster (chairperson)
  • Dr. Morten Sogaard, Vice President and Head Enterprise Scientific Technology Operations in Pfizer Worldwide R&D
  • Dr. Peter Schuld, Head of Medical Affairs Oncology Western European Cluster in Novartis
  • Dr. Anil Singahl, Vice President & Head, AbbVie biotherapeutics
  • Øyvind, Arnesen, CEO Ultimovacs
  • Konstantinos Alevizopoulos, CEO Apim Therapeutics

Session: Neuroscience

  • Leif Rune Skymoen, CEO Nansen Neuroscience Network
  • Dr Scott Brown, Vice President of Pharmaceutical Development in AbbVie
  • Dr. Morten Sogaard, Vice President and Head Enterprise Scientific Technology Operations in Pfizer Worldwide R & D

16.30 to 18.30 Possibility of 1-1 meetings between national and international companies
In agreement with the companies. Interested parties may send email to monica@lmi.no to be put in contact with the international companies.

19.00 to 22.30 Dinner at Cafe Christiania
Lower Vollgate 19, 0158 Oslo (Entrance from Stortingsgaten)

Vaccibody Granted Platform Patent in the US

Vaccibody AS, a biopharmaceutical company focusing on immunotherapy and vaccines, is pleased to announce that the U.S. Patent Office has Issued patent No. US 8,932,603 B2 covering the Vaccibody format which can be described as homodimeric modular constructs targeting vaccines to antigen presenting cells designed to increase the immune system’s antibody and T-cell responses. In December 2014 Vaccibody announced that the equivalent patent was granted by the European Patent Office.

 

This patent protects Vaccibody’s platform technology on which the company has based its lead drug candidate VB10.16 as well as the previously announced license agreement with the Phibro Animal Health Corporation, covering vaccines for poultry. The technology allows for the development of new and more efficient vaccines as well as new versions of existing vaccines with a need for improved efficacy.  It lends itself to therapeutic vaccines, such as cancer vaccines, as well as prophylactic (preventive) vaccines against infections.

The company will utilize its technology platform to develop human and veterinary Vaccibody vaccines both through developing its own drug pipeline as well as offering the pharmaceutical industry exclusive licenses to the technology platform.

The company’s lead product, VB10.16, is being developed as a DNA vaccine to prevent the development of and treat HPV16 induced pre-malignancies and malignancies. The first in man clinical trial is currently in late stage preparations. This initial clinical evaluation will aim to characterise the safety and immunogenicity of VB10.16 in HPV16 infected women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

Tom Pike, Acting CEO of Vaccibody, commented: “This patent is a cornerstone in the protection of our novel technology platform, which is the discovery engine of Vaccibody’s own pipeline. We expect that it will also provide the basis for additional strategic partnerships with pharmaceutical companies in the future. Although Vaccibody has filed a number of additional patent applications offering several layers of protection to our pipeline and technology, this patent family is the first and thus represents an important milestone for the company.”

 

About Vaccibody AS
Vaccibody is a vaccine company dedicated to the discovery and development of novel 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 HPV induced  pre-malignancies and malignancies. A first-in-man study currently in preparation will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) and is planned to be initiated early 2015. www.vaccibody.com

 

Ultimovacs carries out NOK 45 million share issue with Canica AS and Sundt AS as the main investors

Oslo Cancer Cluster member Ultimovacs AS has carried out a successful NOK 45 million share issue with DNB Markets and Arctic Securities as financial advisors. The issue was fully subscribed by new shareholders. The two biggest new shareholders are Canica AS and Sundt AS.

 

The funds raised through the share issue will be used to implement and further develop the company’s programme to document the effect of its first product; the therapeutic cancer vaccine UV1. During the next two years, the company will complete and finish two clinical trials to show how UV1 activates the immune system.

In addition, Ultimovacs began a third trial in January 2015 to explore efficacy and safety of UV1 is in combination with another drug that also manipulates the immune system into attacking cancer cells. The new funds will also cover the costs of this trial and allow the company to establish and document a commercial-scale production process for UV1.

CEO Øyvind Kongstun Arnesen comments: ‘This share issue enables the company to maintain its strong professional focus as it continues its work on documenting efficacy and safety of UV1 is in cancer treatment. We are very pleased to have some of the strongest investment communities in Norway on our team. The new owners recognise the company’s ambitions to improve the current cancer treatment while developing a business enterprise with great potential.’

Canica looks forward to further developing Ultimovacs in cooperation with an expert community and a sound investor base. ‘We believe that the company is well placed to succeed with its innovative immunotherapy,’ says Nils Selte, CEO of Canica.

Leiv Askvig, CEO of Sundt, comments: ‘With its universal cancer vaccine, Ultimovacs has great potential, both when it comes to developing new cancer treatments to benefit patients and creating good value for shareholders.’

Ultimovacs is a biotechnology company that develops a therapeutic universal cancer vaccine. Such cancer treatment is not linked to a specific type of cancer, but has the potential to trigger a general immunologic reaction against cancer cells, regardless of the type of cancer. Stimulating the immune system to attack cancer cells is a revolutionary form of cancer treatment and a treatment principle in rapid international development. Several new treatments based on this principle have already been introduced, and the technology has the potential to greatly improve the treatment options available for cancer. The Norwegian academic communities and companies that belong to Oslo Cancer Cluster are world-leading in this field. Ultimovacs is one such company.

About Ultimovacs:

Ultimovacs AS was established by Inven2 in 2011. The company’s goal is to develop technology from the Norwegian Radium Hospital for use in cancer treatment and to make the treatment available to patients. The technology is based on the possibility of controlling the immune system to make it recognise and kill cancer cells.

Ultimovacs is carrying out three clinical trials intended to document that the company’s main product, UV1, can produce a controlled immune response and is safe to use, either alone or in combination with other drugs that also activate the immune system to attack cancer cells.

The biggest shareholders in the company are Gjelsten Holding AS, Inven2, Langøya Invest AS, Canica AS, Sundt AS and the Norwegian Radium Hospital Research Foundation. From July 2015, the company will be located in Oslo Cancer Cluster Innovation Park at Montebello.

 

Oslo Cancer Cluster Incubator receives SIVA-funding

The governmental agency SIVA will support the Oslo Cancer Cluster Incubator with MNOK 15 over the next 10 years in order to develop cancer treatment from companies that spins out from strong cancer research.

– Oslo Cancer Cluster is leading within a research field that is of great importance for Norway and the World. An Incubator will contribute to more commersialisation, more start-ups and a faster way to the market, says Roy Strømsnes, Head of Communcation in Siva.

Bjørn Klem, General Manager of the Incubator, is very pleased with the support from Siva.

– The  support from SIVA is very important for us. The road to the market for cancer biotechs is demanding, and it is crucial to support the start-ups in the critical first years in order to create more succeful companies.

The Oslo Cancer Cluster Incubator will be situated in the Oslo Cancer Cluster Innovation Park, that will open in August 2015.

 


Read the press release here – Norwegian only:

Krafttak for norsk kreftindustri

 Siva støtter Oslo Cancer Cluster Inkubator med totalt 15 millioner til å utvikle kreftbehandling fra bedrifter som bygger på sterk norsk kreftforskning.

Hvert år får omtrent 30 000 nordmenn kreft. Ringvirkningene er store i kjølvannet av en slik beskjed, både for den det gjelder, familie, venner og jobb. Heldigvis blir mange friske eller lever godt med kreften.

Mest solgte i verden
Det er likevel mange kreftformer vi ikke klarer å behandle, og tradisjonell kreftbehandling som stråling og kjemoterapi har alvorlige bivirkninger. Dette er grunnen til at Oslo Cancer Cluster Inkubator åpner dørene neste år, med mål om å utvikle morgendagens kreftbehandling fra norsk kreftforskning i verdensklasse. Dette vil utgjøre en forskjell for kreftpasienter over hele verden, ikke bare i Norge.

Kreftmedisinen Algeta utviklet til behandling av menn mer prostatakreft med spredning som kom på markedet i 2013, var i 2014 den den femte mest solgte nye kreftmedisinen i verden. Dette viser hvor stort behov det er for nye, innovative behandlinger og at norske bedrifter er helt i front.

– Oslo Cancer Cluster er ledende innen et forskningsfelt som har enorm samfunnsverdi for Norge og verden. En inkubator vil bidra til mer kommersialisering, flere nyetableringer og raskere vei fra laboratorium til marked, sier Roy Strømsnes som er kommunikasjonsdirektør i Siva.

Skal få støtte til suksess
Oslo Cancer Cluster Inkubator skal hjelpe flere kreftselskaper å lykkes med å utvikle sin behandling av ulike kreftformer.

– Hos oss skal forskerne og gründerne få leie lab, kontorplass og samtidig ha tilgang til et nettverk av kompetansepersoner som de kan trekke på når de trenger det. Veien til markedet er krevende, og vi skal hjelpe bedriftene i den kritiske oppstartsfasen for å skape flere suksesbedrifter, sier Bjørn Klem som starter som leder av Oslo Cancer Cluster Incubator i januar 2015.

Klem viser til at da det norske kreftselskapet Algeta ble solgt for 18 milliarder norske kroner til Bayer, så styrket den norske kronen seg.

Kommersialiseringsselskapet Inven2 mener Oslo Cancer Cluster Inkubator vil være med å bygge norsk helsindustri.

– Oslo Cancer Cluster Inkubator er en svært viktig byggestein på veien mot en slagkraftig helsenæring i Norge. Der vil oppstartselskaper møte stor industri og være tett på banebrytende kreftforskning, og inkubatoren vil gi dem større sjanser for å lykkes med å bringe nyttige produkter til markedet, sier Ole Kristian Hjelstuen, daglig leder i Inven2.

Betyr mye for pasientene
Oslo Cancer Cluster er overbevist om at inkubatoren som nå skal utvikles vil bety mye for kreftpasienter over hele verden.

– Vi er utrolig glad for denne støtten fra Siva, dette betyr mye for bransjen og vil bety mye for pasientene. Siva er også en av eierne av Oslo Cancer Cluster Innovasjonspark, som gjør at vi får samlet hele verdikjeden innen kreftforskning- og utvikling på ett sted i Oslo, sier Ketil Widerberg, leder av Oslo Cancer Cluster som er en nettverksforening som samler hele kreftmiljøet i Norge og knytter det opp mot lignende organisasjoner internasjonalt.

Oslo Cancer Cluster har siden 2010 hatt en liten inkubator i sine kontorlokaler på Lysaker og har bare god erfaringer med det.

– Vi ser at det å sitte sammen gir gunstige synergier og det er flere av selskapene som har kommet lengre enn antatt med utviklingen av sine kreftbehandlinger på grunn av dette, sier Widerberg.

Kontaktpersoner:

Oslo Cancer Cluster Inkubator:
Bjørn Klem // daglig leder // mobil: 92 41 61 56

Oslo Cancer Cluster:
Ketil Widerberg // daglig leder // 915 77 990

Siva
Roy Strømsnes // kommunikasjonsdirektør // 909 3 3 114
Om oss:

Oslo Cancer Cluster Inkubator

Oslo Cancer Cluster Inkubator tilbyr kontor og laboratorier til forskere og start-ups som utvikler kreftbehandling. I tillegg får leietagerne tilgang på et bredt nettverk av kompetente støttespillere. Målet til inkubatoren er å utvikle flere bedrifter fra norsk kreftforskning, samt bidra til at bedriftene lykkes. Det er per i dag noe ledige lokaler i Inkubatoren som åpner offisielt 24. august 2015.
www.occincubator.com

Oslo Cancer Cluster

Oslo Cancer Cluster er en not-for-profit medlemsorganisasjon som samler hele kreftmiljøet i Norge. Klyngen er i tillegg den eneste innen helse som har status som Norwegian Center for Expertise. Vår visjon er å akselerere utviklingen av morgendagens kreftbehandling til det beste for kreftpasientene. www.oslocancercluster.no

Siva

Siva gir næringslivet rom til å vokse gjennom å investere i eiendom, innovasjonsselskap og utvikling av oppstartsmiljø. Selskapets hovedmål er å utløse lønnsom næringsutvikling i bedrifter og regionale nærings- og kunnskapsmiljø. Siva er et statsforetak eid av Nærings- og fiskeridepartementet. www.siva.no

Inven2

Inven2 er innovasjonsselskapet til Oslo universitetssykehus og Universitetet i Oslo, og kommersialiserer idéer fra forskningen. I 2013 opprettet Inven2 syv selskaper og inngikk 31 lisensavtaler. Selskapsporteføljen til Inven2 er på 32 selskaper og er nå verdt 1,6 milliarder kroner, inkludert en rekke selskaper som utvikler legemidler mot kreft. www.inven2.no

 

Oslo Cancer Cluster`s start-ups highlighted in investor report

A recent analysis from the audit and advisory company EY is cautiously optimistic on behalf of startup companies in the Nordic Life Science industry – and points to possibilities within Oslo Cancer Cluster.

The analysis, which was commissioned by Norwegian Investinor and Swedish Industrifonden, points to four segments in the Nordic life science market that has the most mature startup companies, and thus are believed to be most attractive for investments: oncology (cancer treatment), inflammation treatment, niche products and imaging. From these segments, several startup companies have already appeared. They have also raised substantial capital.

Some Norwegian examples are Nordic Nanovector, BerGenBio and Targovax, which has raised a total of NOK 485 million in 2014 .These companies are all members of Oslo Cancer Cluster, developing cancer treatments using different technologies.

Excellent quality of research
The strength of the Nordic life science industry is the quality of the research performed, especially in some selected clusters, such as the Oslo Cancer Cluster. Scientific development is a key driver for innovation in the highly regulated pharmaceutical industry.

The biggest concern among life science industry players interviewed in the survey is however, the attention from investors, especially from professional investors with industry insights, which can handle the risks of investing in the earliest stages of company development.

─ The early phase of life science involves great risk, but can also give great returns, so investors should pay close attention to what is now happening in Oslo Cancer Cluster and corresponding clusters, says Ann- Tove Kongsnes, Investment Director of Investinor.

Investinor actively works to attract more foreign investors to Norwegian life science industry, and has also made ​​two investments together with Swedish Industrifonden in Oslo Cancer Cluster members Smartfish and Pharmalink.

 

 

 

 

BerGenBio Completes NOK90 Million Fundraising

Oslo Cancer Cluster member BerGenBio AS, a biopharmaceutical company focused on developing innovative drugs for aggressive drug resistant cancers, announces that it has raised NOK90 million (c. $15 million) in a private placing from new and existing investors.

BerGenBio will use the proceeds from the financing to support the development of its pipeline of innovative cancer therapeutics, in particular an enlarged clinical development program for its lead drug candidate, BGB324, a first-in-class selective Axl kinase inhibitor, which is currently in Phase 1b clinical trials for patients with acute myeloid leukaemia (AML).

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

“I am delighted we have received continued funding support for the Company and our clinical development plans for BGB324. Our recent research findings have shown broader potential clinical application for BGB324, and we intend to evaluate these in additional Phase 1 and Phase 2 clinical trials starting in 2015. In aggressive drug resistant cancers our on-going Phase 1b trial in AML is expected to report towards the end of 2015 and in non-small-cell-lung-cancer we will start enrolling patients very soon.”

Ann-Tove Kongsnes, Investor Director at Investinor, commented:

“We are very satisfied with the development of BerGenBio and its exciting pipeline of first-in-class cancer therapies. In the near future we see attractive opportunities for value uplift in the Company and are pleased to support the business.”

Arctic Securities AS acted as sole bookrunner for the private placement.

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 drug-resistance and metastasis.

About BerGenBio AS
BerGenBio AS is a clinical stage biopharmaceutical company. The Company is committed to developing innovative therapeutics that inhibit EMT, prevent the formation of cancer stem cells and disrupt the cellular mechanisms that drive acquired cancer drug resistance. The Company is founded on proprietary platform technology, CellSelect™, which uses information from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is the first compound in BerGenBio’s pipeline to enter clinical trials in AML and soon NSCLC, with additional compounds and drug targets at different stages of preclinical development. www.bergenbio.com

Gunnar Gårdemyr appointed CEO in Targovax

The board of Targovax is pleased to announce Mr. Gunnar Gårdemyr as the new CEO from January 12th, 2015.

Mr Gårdemyr has more than 30 years of international experience from the pharmaceutical and biotech industry. His experience includes management, business development, mergers & acquisitions, global marketing and commercial strategy. He holds the position as Corporate Advisor for Acino Pharma in Basel, Switzerland today. Prior to this position, he was Senior Vice President, Corporate Development/M&A, Global Business Development, Nycomed and Senior Vice President, Global Marketing, Takeda in Zurich, Switzerland, where he was in charge of the commercial assessment of external business development licensing opportunities.

Mr Gårdemyr started his career in Astra, followed by Ferring, Tigran Technologies and Retinalyze.

He has a Bachelor of Science in Business Administration and Economics from the University of Lund, Sweden.

Jónas Einarsson, Chairman of Targovax, says, “We are delighted to welcome Gunnar Gårdemyr to Targovax. Our ability to attract an experienced industry executive with Gunnar’s track record and knowledge reflects Targovax` potential. His leadership will accelerate the company’s further development”.

“We are very grateful to Hanne Mette D. Kristensen for her contribution by leading Targovax from establishment to a phase II company”, says Jónas Einarsson.

 

Facts:

Targovax
Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccines based on pioneering research at the Norwegian Radium Hospital and Norsk Hydro. Mutation of RAS is an early mutation in the transformation of a normal cell into a cancer cell. Lead candidate TG01 educates the body’s immune system to recognize and kill cancer cells with RAS mutations. TG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase II trials in operated pancreatic cancer, patients start treatment up to 12 weeks after surgery. The company is located in Lysaker, close to Oslo, Norway.
www.targovax.com

 

 

 

 

 

 

 

BerGenBio Announces First Patient Dosed in BGB324 AML Trial

Oslo Cancer Cluster member BerGenBio AS announces first patient dosed in its multi-centre Phase 1b trial (BGBC003) of BGB324, a selective inhibitor of Axl, in patients with acute myeloid leukaemia (AML) at Haukeland University Hospital in Bergen, Norway.

The two part Phase 1b trial will primarily investigate the safety and tolerability of BGB324 when administered as a single agent and in combination with standard of care drug (cytarabine) in patients with AML; secondary endpoints will also explore evidence of clinical response and assess novel biomarkers. The study will be conducted at six sites in Norway, Germany and the United States. The Company expects data to be available from this trial in 2015.

Professor Bjørn Tore Gjertsen, Principal Investigator at Haukeland University Hospital, said:

“BGB324 is a potential breakthrough treatment for patients with aggressive AML, and it is particularly encouraging that a forward-thinking biotech company like BerGenBio prioritised a trial for patients with this aggressive blood cancer. I am delighted that I am able to offer this experimental drug to my patients and to allow us to test a novel therapeutic concept in patients that have limited treatment options.”

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

“We continue to progress BGB324, our first-in-class selective Axl inhibitor, through early clinical development; recently we also received FDA clearance and this trial will open imminently in the United States and at sites in Germany. The novel mechanism of action of this class of drugs holds great potential as a treatment for many aggressive drug resistant cancers; we will also investigate BGB324 in non-small cell lung cancer (NSCLC). Therefore we see successful completion of this study as a key value inflection point for the Company. We expect preliminary data from these studies in 2015.”

About the BGBC003 trial
BGBC003 is a multi-centre Phase 1b trial of BGB324, a selective inhibitor of Axl, in patients with acute myeloid leukaemia (AML) The two part Phase 1b trial will investigate dose escalation and expansion of BGB324 in patients with refractory/relapsed AML an aggressive form of cancer in which certain types of white blood cells (granulocytes or monocytes) become cancerous, at six sites in three countries.

The primary objective of the first part of the trial is to identify the maximum tolerated dose (MTD) of BGB324 and the secondary objectives are to identify the dose limiting toxicity (DLT), safety and tolerability and confirm the pharmacokinetics of the drug candidate. The primary objective of the second part of the trial is to identify the safety, and tolerability of BGB324, as a single agent and in combination with low dose cytarabine, with a secondary objective of determining the efficacy of BGB324 as a single agent and in combination with low dose cytarabine.

 

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 drug-resistance and metastasis.

 

About Acute myeloid leukaemia
Acute myeloid leukaemia (AML) is an aggressive cancer of the blood and bone marrow. It is characterised by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and prevent the production of other normal blood cells. It is estimated that 1 in 243 people will be diagnosed with AML during their lifetime. In the United States, the five-year overall survival is 24%. It is estimated that 40-45% of patients younger than 65 years can be cured with current therapies, however only 10% of older patients achieve long-term survival. BerGenBio has shown that more than 50% of AML patients have elevated levels of Axl and by inhibiting Axl with BGB324 in preclinical studies a substantial and potentially therapeutic reduction in leukaemic burden can be achieved.

 

About BerGenBio AS
BerGenBio AS is a clinical stage biopharmaceutical company. The company is committed to developing innovative therapeutics that inhibit EMT, prevent the formation of cancer stem cells and disrupt the cellular mechanisms that drive acquired cancer drug resistance. The company is founded on proprietary platform technology, CellSelect™, which uses information from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is the first compound in BerGenBio’s pipeline to enter clinical trials in AML and NSCLC, with additional compounds and drug targets at different stages of preclinical development.

www.bergenbio.com

 

Targovax AS has reached primary endpoint in ongoing phase I/II trial

Oslo Cancer Cluster member Targovax AS has reached an important milestone in the ongoing clinical trial investigating its cancer vaccine TG01 for treatment of operable pancreatic cancer.

Targovax announces that the primary endpoint for the ongoing phase I/II clinical trial CT TG01-01, regarding immune response and side effects, is already reached. Recruitment of patients for the clinical trial will continue according to protocol and plan as basis for readout of secondary endpoints.

Immunotherapeutic cancer vaccines
Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccines based on pioneering research at the Norwegian Radium Hospital and Norsk Hydro. Mutation of RAS is an early mutation in the transformation of a normal cell into a cancer cell. Lead candidate TG01 educates the body’s immune system to recognize and kill cancer cells with RAS mutations.

TG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase II trials in operated pancreatic cancer, patients start treatment up to 12 weeks after surgery. The company is located in Lysaker, close to Oslo, Norway.

 

FACTS

Immuno- oncology / Cancer vaccines
The Norwegian cancer research community has been in the forefront of understanding the mechanisms for immuno-oncology and cancer vaccines. A cancer vaccine educates the body’s immune system to recognize and kill the cancer cells. The TG01 vaccine is therapeutic and is given as treatment to patients after surgery of cancer patients, to prevent relapse.

Pancreas cancer and other RAS-mutated cancer forms
Pancreatic cancer is a disease affecting 116 000 patients each year in EU and USA, and approximately 690 persons each year in Norway. Approx 15-20% of these are discovered at an early stage and are operable. The mortality is high, and the prognosis for these patients has been more or less unchanged the last 30 years. Approximately 80-90% of patients with pancreatic cancer have RAS mutations in the cancer cells.
RAS mutations occur in approx. 20% of all cancer cases, and are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.

Flocking to Norway

Oslo’s cancer research community attracts international attention. Foreign companies engaged in the cancer field are flocking to Norway and Oslo to benefit from the city’s cancer research community. ‘This is a stamp of quality,’ says Ketil Widerberg, General Manager of Oslo Cancer Cluster.


This article is written by journalist Ina Vedde Fjærestad, and was published in KAPITAL 14/2014.
Oslo Cancer Cluster have kindly been allowed to translate it to English and publish it on our site.


 Several foreign companies are now showing an interest in establishing themselves in the capital to become part of Oslo Cancer Cluster. They are attracted by the close-knit environment for cancer research and development of drugs, treatment and diagnostic methods for cancer.

Major interest from abroad.
‘The fact that foreign companies are coming to Oslo is a stamp of quality for the Norwegian community and what we are developing here. It is also important in relation to developing an industry based on cancer research,’ says Widerberg of Oslo Cancer Cluster to Kapital business magazine. He does not want to reveal any names, but confirms that several foreign companies have shown an interest.

‘These are companies in the cancer field from countries such as the UK and Denmark – companies at the clinical stage,’ says Widerberg. He recently attended the world’s biggest biotechnological convention in San Diego, and says that he was surprised by the amount of interest several major companies showed in Norwegian research.

‘Several people contacted me and wanted to arrange a meeting to hear more about our work here.’
Kapital has information that the Danish company Rhovac is among the companies considering setting up in Norway. The company is at the final pre-clinical stage in the development of potential vaccines for cancer treatment.

Funding as a pull factor
Oslo Cancer Cluster was established in 2006 and currently has almost 70 members – enterprises, organisations, hospitals and universities that engage in cancer diagnostics and treatment. The cluster brings together the whole value chain in cancer treatment – everything from research institutions to hospitals, financial institutions and the big pharmaceutical companies.

The cluster is partly publically funded as a Norwegian Centre of Expertise (NCE). The overriding objective is to improve the lives of cancer patients by stimulating the development of new cancer drugs and diagnostics. The research community in Oslo has become especially well known for its expertise in immuno-oncology, a field that involves triggering the body’s own immune system in the battle against the cancer cells. This field attracts particular attention from foreign companies.

‘We are experiencing increasing interest from abroad, which is fun and a sign of recognition of our community,’ says Jónas Einarsson, CEO of the Norwegian Radium Hospital Research Foundation. He confirms that they are now working with four companies from Sweden, Denmark, the UK and Germany, respectively, some of which are considering moving their whole company to Norway.
Competitors and collaborators
The companies that choose to become Norwegian also gain access to good schemes for companies that engage in what is known as early-phase research. For example, they can apply for funding from the SkatteFunn tax relief scheme. All Norwegian companies that run research projects can apply for tax relief under this scheme.

‘Of course, the more companies that establish themselves and develop projects in this field, the better. We achieve good cluster dynamics. The companies compete for the same funding and investors, and will be competing in the same market later. At the same time, they can benefit in many ways from synergies and collaboration in the development phase,’ says Einarsson. He is often part of the delegations that present Oslo Cancer Cluster around the world.
‘Many Norwegian companies are going to the Nordic Life Science conference in Stockholm this September. We also attended the biotechnology convention in San Diego in June. We went there to look for partners in the bio-pharmaceutical field, to attract investors, and to help to market Norway as an exciting location for such companies.’

The Swedish company Pharmalink has decided to establish a subsidiary in Norway called Pharmalink Oncology. Pharmalink is engaged in speciality pharma, focusing on rare diagnoses for which they develop what is known as ‘orphan drugs’. The company currently has two products at the clinical stage, Nefecon and Busulipo, and is owned by the government investment company Investinor, Industrifonden and two of the entrepreneurs.

‘Our goal here in Oslo is to buy oncology projects where the research has come a long way and to expand our portfolio,’ said Johan Häggblad in a network meeting organised by Oslo Cancer Cluster on 20 August.

Important to the network
OncoImmunity is a company established by Richard Stratford from Britain, Trevor Clancy from Ireland and Norwegian professor Eivind Hovig. The company develops software intended to be able to assess tumour mutation and identify specific antigens in order to make it possible to use the body’s immune system to fight cancer.

‘The information obtained will help to pick the patients who will respond best to immunotherapy-based treatment. This will lead to a higher success rate at the clinical stage of the development and may spare patients unnecessary treatment.’ says Stratford.

Today, less than seven per cent of cancer drugs enter the clinical stage for the treatment that was the initial intention behind their development. ‘There is a great need for a review of and new methods in this field.’

OncoImmunity became a member of Oslo Cancer Cluster (OCC) in June this year. ‘We see OCC as a good forum for networking – for finding partners and potential investors.’ Stratford has lived in Norway for seven years, and has worked in the biotechnology field for most of that time. He was familiar with OCC before the company became a member. ‘The biggest advantage is the network and support OCC provides. They have a great team that has worked very actively to connect OncoImmunity to valuable contacts in research and development.’

 

DNB invites to informal Healthcare gathering

You are invited to our informal gathering and DNB event for key personell in the Norwegian health care industry, 12th of November 2014.


Please sign up by November 5th to https://www.deltager.no/DNBHealthcare_2014.

Welcome to the DNB Healthcare event 12th of November in DNB’s Headquarter in Bjørvika, Dronning Eufemiasgt 30.

Agenda
16:30-17:00 Registration and light food

17:00-17:10 Welcome and introduction
Terje Straume, Head of International Healthcare DNB

17:10-17:20 Oslo Cancer Cluster – a dedicated oncology cluster
Ketil Widerberg, CEO Oslo Cancer Cluster

17:20-17:40 Healthcare – a prioritized industry sector for DNB
Anders Grevstad, Head of Division International Corporates DNB

17:45-18:45 Business development from an industry perspective – triggers and opportunities
Gaël L’Hévéder, Chief Business Development Officer, PCI Biotech

18:50-19:20 Panel debate

  • Veronika Barrabes, Country Manager Novartis Norge
  • Anders Tuv, Investeringsdirektør Radiumhospitalets forskningsstiftelse
  • Unni Hjelmaas, CEO Lytix Biopharma
  • Karita Bekkemellem, CEO Legemiddelindustriforeningen
  • Benedicte Bakke, Senior Advisor, International Healthcare DNB

19:30 Dinner and networking in restaurant 16th floor

 

Lifstream with in debth articles on Oslo Cancer Cluster

Karl Simpson from Liftstream, a company that provides recruitment services to the global life sciences sector, visited the Oslo Cancer Cluster this Summer. Simpson just published in-debth analysis of both the cluster and some of the members. Please read an excerpt below and more on their web site www.liftstream.com.

“Oslo, Norway is home to the emerging Oslo Cancer Cluster, a growing cluster with a host of exciting companies targeting the oncology therapeutics and diagnostics marketplace. These companies include, Nordic Nanovector, Lytix BioPharm, Targovax and Ultimovacs.

The Oslo Cancer Cluster has big ambitions to create a global cluster comprised of world-leading experts in cancer drug development and diagnostics and wishes to attract this competence.

With a brand new innovation centre to be launched in 2015, this is an exciting time for this biotech cluster and the companies in it. Liftstream has taken time to profile the cluster through interviews with the Oslo Cancer Cluster leadership, as well as CEO’s of some of the cluster’s companies.”

New CEO in Nordic Nanovector

The Board of Nordic Nanovector is pleased to announce the appointment of Mr. Luigi Costa as new CEO of the Company.

Mr. Costa has over 20 years of international pharmaceutical and biotech experience. Most recently he held the position of Vice President Europe, Middle East and Africa for Onyx Pharmaceuticals, a global biopharmaceutical company based in South San Francisco, California. He was responsible for the startup of the Company’s international organization and for the pre-launch and launch of its Hematology potential blockbuster Kyprolis outside the US.

Will start 1st September
Prior to joining Onyx Pharmaceuticals, he held several roles of increasing responsibility with Amgen including Head of International Oncology Franchise, General Manager of Italy and Vice President and General Manager of France, the Company’s largest market outside the US. Mr. Costa, is a highly successful senior commercial bio-pharma/’biotech’ leader in Europe.

He has delivered a track record across diverse products and therapeutic areas with experience gained on both sides of the Atlantic. Mr. Luigi Costa will take over as CEO on the 1st September 2014.

Important phase of internationalization
”We are about to enter a new and more international phase in the development of Nordic Nanovector. The Board is therefore pleased that Mr. Luigi Costa has accepted to take over the helm as CEO and take the Company to its new phase,” says Chairman Roy H. Larsen on behalf of the Board. ”We see this as yet another professional acknowledgement of the Company and its product Betalutin’s future potential.”

”We are grateful for Jan A. Alfheim’s personal commitment and contributions as CEO in building up the organization of the Company in the first years of its lifetime” says Roy H. Larsen.

 

FACTS:

About Nordic Nanovector AS
Nordic Nanovector AS is a privately held company established in 2009. The company is based in Norway and has offices and laboratories in Oslo. The company is developing novel innovative anticancer radioimmunotherapeutics to treat non-Hodgkin Lymphoma (NHL) and other hematological malignancies.

About Betalutin
Betalutin™, is a pharmaceutical product candidate consisting of a radionuclide conjugated to a tumor seeking carrier/antibody, which can be used for irradiation of malignant metastasized tumors with minimal damage to nearby healthy normal tissue. This technology aims to prolong and improve the quality of life of people who suffer from non-Hodgkin Lymphoma (NHL).

Major Oslo Cancer Cluster delegation to Nordic Life Science Days/ECCP2014

The largest Nordic Life Science conference “Nordic Life Science Days” (NLSDays) will take place in Stockholm September 7-9. At present 652 delegates from 456 companies are registered – offering 339 licencing opportunities.

A large delegation from Oslo Cancer Cluster will join this years NLSDays that also features the European Cancer Cluster Partnering, which Oslo Cancer Cluster hosts together with French Cancer Bio-Santé.

17 members present
As of now, 17 Oslo Cancer Cluster member companies will be present at NLSDays/ECCP: APIM Therapeutics, Inven2, Nextera, Ultimovacs, Lifandis, Vaccibody, Norwegian Cancer Society, LINK Medical Research, Lytix Biopharma, Targovax, NTNU Technology Transfer, Oncoimmunity, Bergen Technology Transfer, Birk Venture, Oslo University Hospital, University of Oslo and PCI Biotech.

ECCP Oncology Track
The ECCP Oncology Track features a strong oncology program focusing on three major topics; early stage oncology possibilities, Immuno-Oncology and the coupling of biomarkers, bio banks and big data in cancer treatment. Major international speakers will join and the program covers the whole value chain from research to market.

Norwegian stand promoting Norwegian Healthcare Industry
Kindly sponsored by Innovation Norway, Oslo Cancer Cluster and Nansen Neuroscience Network organizes a joint conference booth promoting cluster members and the Norwegian Life Science sector. Please come and visit us to hear more about the strengths of Norwegian Healthcare Industry. The joint Norwegian Stand will be served by the Management Teams of both clusters.

More information www.nlsdays.com

 

Vaccibody successfully completes a 35 million NOK financing

Vaccibody has in a new share issue completed a 35 MNOK (4.3 million €) financing from existing and new investors. The share issue was significantly oversubscribed.

The largest new investor is represented by Datum and partners, which will take a seat in the Board of Directors. Arctic Securities is the manager for the share issue. The finalization will take place in the extraordinary general meeting on July 9th.

“We are very pleased to see such a great interest in Vaccibody AS and I look forward to take the company into a new stage by initiating our first clinical study. I very much welcome our new strong investor group and look forward to a fruitful collaboration in the years to come..” CEO, Ole Henrik Brekke

For further information please contact:
CEO Ole Henrik Brekke, ohbrekke@vaccibody.com, +4792628434
Please visit www.vaccibody.com

Nordic Nanovector: Successful closing of MNOK 250

Oslo Cancer Cluster member Nordic Nanovector announce that the company has closed its pre-IPO private placement of NOK 250 million – 100 million more than anticipated.

The private placement, which was directed towards existing shareholders as well as new institutional and professional investors, attracted strong investor interest and was increased from  NOK 150 million to NOK 250 million on the basis of strong demand from solid institutional investors.

Further developing Betalutin™
The private placement was managed by ABG Sundal Collier and DNB Markets and was significantly oversubscribed. Nordic Nanovectors largest shareholder, HealthCap V. L.P. participated in the placement and was allocated 1,800,000 shares. Nordic Nanovector intends to use the net proceeds of the private placement to fund further clinical development of Betalutin™ for treatment of non-Hodgkin Lymphoma.

Norwegian paper DN published this article on the news, siting Roy Larsen: “This may be the new Algeta”.

About Nordic Nanovector AS
Nordic Nanovector AS is a privately held company established in 2009. The company is based in Norway and has offices and laboratories in Oslo. The company is developing novel innovative anticancer radioimmunotherapeutics to treat non-Hodgkin Lymphoma (NHL) and other hematological malignancies.
Read more on Nordic Nanovector`s web page.

About Betalutin
Betalutin™, is a pharmaceutical product candidate consisting of a radionuclide conjugated to a tumor seeking carrier/antibody, which can be used for irradiation of malignant metastasized tumors with minimal damage to nearby healthy normal tissue. This technology aims to prolong and improve the quality of life of people who suffer from non-Hodgkin Lymphoma (NHL).

Nordic Nanovector: Betalutin™ granted Orphan Designation in Europe

Oslo Cancer Cluster member Nordic Nanovector`s  lead product candidate Betalutin™ has been granted orphan designation for treatment of follicular lymphoma in Europe by the European Medicines Agency (EMA) and the European Commission (EC).

Orphan designation for Betalutin™ will provide the company several advantages, including reduced costs related to the clinical development program, as well as commercial exclusivity for ten years once the product reaches the market in Europe.

Market exclusitivity
Jan A. Alfheim, Nordic Nanovector CEO stated: “With the orphan designation for Betalutin™ in the Europe, the company can receive protocol assistance, a type of scientific advice specific for designated orphan medicines and market exclusivity once the medicine is on the market. Fee reductions are also available. These benefits will help tremendously in the development and commercialization of an important new form of treatment of non-Hodgkin Lymphoma“.

About Nordic Nanovector AS
Nordic Nanovector AS is a privately held company established in 2009. The company is based in Norway and has offices and laboratories in Oslo. The company is developing novel innovative anticancer radioimmunotherapeutics to treat non-Hodgkin Lymphoma (NHL) and other hematological malignancies.

About Betalutin
Betalutin™, is a pharmaceutical product candidate consisting of a radionuclide conjugated to a tumor seeking carrier/antibody, which can be used for irradiation of malignant metastasized tumors with minimal damage to nearby healthy normal tissue. This technology aims to prolong and improve the quality of life of people who suffer from non-Hodgkin Lymphoma (NHL).

 

Targovax successfully completes a 70 MNOK financing

Immunotherapy specialist Targovax announces completion of a 70 MNOK financing, mainly from new investors. The share issue was significantly oversubscribed.

CEO Hanne M Kristensen states; “The capital increase of 70 MNOK will make us able to continue developing Targovax’s pipeline of immunotherapies targeting RAS mutated cancer forms, and also gives us a strong position to develop Targovax as a company”.

Chairman Jónas Einarsson comments; “This is an important step forward for Targovax, and clearly shows that the Norwegian investment community has opened its eyes to our sector.”

Datum and partners represent the largest new group of shareholders, and look forward to working together with the company management in the years to come, to develop the company’s potential.

Arctic Securities ASA is the manager for the share issue. The company will be OTC-listed shortly after completion of the financing round.

Read more about Targovax here.

 



In Norwegian:

Immunterapi-spesialisten Targovax annonserer i dag gjennomføringen av en suksessfull kapitalutvidelse på 70 MNOK (11.5 MUSD), hovedsakelig fra nye investorer. Kapitalutvidelsen var vesentlig overtegnet.

CEO Hanne M Kristensen sier: “Kapitalutvidelsen på 70 MNOK gjør oss i stand til å fortsette å utvikle Targovax’ pipeline av immunterapi rettet mot RAS-muterte kreftformer, og gir oss en solid posisjon for å utvikle Targovax som selskap.“

Styreleder Jónas Einarsson kommenterer; “Dette er et viktig skritt fremover for Targovax og viser med all tydelighet at investormiljøet for alvor har fått øynene opp for vår sektor.“

Datum og partnere representerer den største nye gruppen av aksjonærer, og ser frem til å arbeide med selskapets ledelse i årene fremover for å utvikle selskapets potensial.

Arctic Securities ASA har vært tilrettelegger for kapitalutvidelsen. Selskapet vil bli OTC-listet kort tid etter gjennomføring av kapitalutvidelsen.

 

The Norwegian Cancer Society invest in Vaccibody

The Norwegian Cancer Society (NCS) have established an investment fund for Norwegian oncology companies. With the promising development of VB10.16, Vaccibody’s therapeutic vaccine against HPV induced precancerous lesions, NCS has decided to place their first investment in Vaccibody.

NCS will invest 500,000 euros. For publication in Norwegian, see Dagens Næringsliv.

“We are very pleased to see that Vaccibody has fulfilled all investment criteria demanded by NCS and is very proud that we are the first company they are investing in. This investment is an important step toward the financing of our first-in-man study”, CEO Ole Henrik Brekke says in comment.

Read more on Vaccibody.
Read more on the NCS`s investment fund.

Positive results on bile duct cancer from PCI Biotech

The PCI Biotech stock went straight up on the Norwegian Stock Exchange after successful results from the first dose cohort in the phase I/II study of Amphinex in combination with the cytotoxic agent gemcitabine in patients with inoperable bile duct cancer (cholangiocarcinoma). No safety concerns were observed at this dose level.

PCI Biotech have previously shown promising results from phase I/II on head- and neck cancer using the same technology as in this phase I study on bile duct cancer, where the three first patients now has been treated.

Targeted therapy
The PCI-technology was developed at the Norwegian Radium Hospital in the nineties, and is a targeted therapy using light to enhance the effect of existing drugs. PCI is an abbreviation for photochemical internalisation and refers to the process of using light to destabilize the cell membrane of the cancer cells in order to deliver the cancer drug effectively.

Bile duct cancer is rare, but extremely severe. PCI Biotech have chosen bile duct cancer due to a clear medical need for a better local treatment, access with light is easy by using already established treatment procedures and one of the most used cytotoxic agents, gemcitabine, is one of the drugs that is significantly enhanced by PCI in preclinical studies.

Please read the press release here.

The PCI technology
Photochemical internalisation (PCI) technology is a technology for light-directed drug delivery, used to enhance the effect of drugs by targeted illumination of the diseased areas of the body.

About PCI Biotech
PCI Biotech has been listed on Oslo Stock Exchange since 2008. The company is offering effective local treatment solutions in cancer through its proprietary photochemical internalisation (PCI) technology. PCI Biotech’s lead photosensitiser Amphinex® is in Phase II clinical development in head and neck cancer in combination with the cytotoxic bleomycin and in Phase I/II clinical development in bile duct cancer in combination with gemcitabine. Read more on PCI Biotech’s website

ICCS 2014: Cutting-edge oncology innovations

On June 22nd, one day prior to the BIO International Convention in San Diego, the International Cancer Cluster Showcase 2014 kicks off. The showcase is an opportunity to head-start the partnering at BIO 2014 and get the latest on what is going on in the cancer clusters of Oslo, Massachusetts, Quebec, Chicago, Toulouse, and the UK Golden Triangle.

For the 3rd time Oslo Cancer Cluster will present cutting edge innovations together with its international partners from North America and Europe. Oslo Cancer Cluster members selected to present at this year’s International Cancer Cluster Showcase (ICCS) are BerGenBio, PCI Biotech and Nextera.


ICCS – A winning concept

Previous ICCS-events have attracted 150 – 200 dedicated international oncology professionals. Positive feedback has encouraged Oslo Cancer Cluster and its international partners to continue with this meeting format. BerGenBio’s CEO Richard Godfrey says:

“The ICCS was a great start to BIO 2013, it was interesting to see the other cancer companies present and we made a few excellent contacts that otherwise we may not have connected with. I will certainly be present at ICCS 2014.”

This year two new partners, namely Cancer Campus from Villejuif and Stockholm-Uppsala Life Sciences are joining the ICCS and contribute to leverage the portfolio of oncology partnering opportunities. The International Cancer Cluster Showcase 2014 will be hosted at the San Diego Convention Centre, same site as the BIO 2014 will be hosted.

For information on presenting companies and registration, please see the ICCS conference website: www.internationalcancercluster.org.

 

BIO International Convention 23-26 June, 2014
Oslo Cancer Cluster will also be represented at the world’s largest biotech conference, BIO International Convention. This year the event is taking place on 23-26 June in San Diego, California at the San Diego Convention Center.

Oslo Cancer Cluster will share a centrally located booth with the other Nordic regions; Medicon Valley Alliance, Biopeople, Invest in Skåne and Copenhagen Capacity. All Oslo Cancer Cluster members may display material at the booth which will function as a central meeting place for the members, coordinated by the Oslo Cancer Cluster team.

Building strong international networks to stimulate collaboration, partnerships and thereby innovation for our members is a key strategic goal for Oslo Cancer Cluster. Read more here.

More information about BIO 2014 is found at convention.bio.org.

Bergen Bio Raises MNOK 75

BerGenBio AS, an oncology biopharmaceutical company, announces that it has raised NOK75 million (c.$12.5 million) from a syndicate of new and existing investors through a private placement. This follows a $6.0 million round in May 2013.

Proceeds from the financing will be used to support the development of the Company’s innovative portfolio of innovative cancer therapeutics.This includes the on-going clinical development of its lead drug candidate, BGB324, a first-in-class selective AXL kinase inhibitor, which is currently in Phase Ib clinical studies to evaluate its safety and initial signs of efficacy to treat different cancers as a single agent and in combination with other drugs.

Fund pipeline advancement
The funds raised will be used to complete these studies, data from which is anticipated in 2015. BGB324 is the only selective Axl receptor tyrosine kinase inhibitor in clinical development to target tumour epithelial-mesenchymal transition (EMT) and has a potential application as a novel treatment for drug-resistant solid and hematological cancers, including non-small cell lung cancer and acute myeloid leukemia.

Richard Godfrey, CEO of BerGenBio commented: “I would like to thank our new and existing investors for their support. This important funding will enable us to advance our pipeline to key value inflection points. We believe that targeting Axl is a promising new approach to treating drug resistant cancers. We look forward to using this investment to continue exploring the clinical opportunity for our lead Axl inhibitor, BGB324, and our other candidate compounds.”

Huge market potential
Sveinung Hole, Managing Partner Sarsia Seed commented “At the seed stage we recognised the huge addressable market potential for BerGenBio`s EMT inhibitors and have continued to support the Company throughout its development. I am delighted the Company continues to attract funding and is able to progress its promising pipeline of novel targeted cancer therapies through further clinical development and realising significant value gain.

Ann-Tove Kongsnes, Investment Director, Investinor AS added, `we are excited by the Company’s prospects and are confident in the management team’s ability to drive these programs forward.”


About the Axl kinase receptor

The Axl tyrosine kinase receptor is regarded as one of the most promising new therapeutic targets for cancer drug  development It is upregulated in tumours residing in a hostile micro-environment and plays a crucial role in the epithelial-mesenchymal transition (EMT), which in turn is a key driver of metastasis (cancer spread) and a mechanisms of acquired drug-resistance.

About BerGenBio AS
BerGenBio AS is a biopharmaceutical company located in Bergen, Norway. The company is committed to developing first in class therapeutics that inhibit tumor EMT, preventing the formation of cancer stem cells and disrupting the important mechanisms of acquired cancer drug resistance. The company is founded on proprietary platform technology called CellSelect™, which uses information from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is the first compound in BerGenBio’s pipeline to enter clinical trials, with additional compounds and drug targets at different stages of preclinical development. www.bergenbio.com

 

Targovax in phase IIa with cancer vaccine

Immunotherapy specialist Targovax reaches Phase IIa in operable pancreatic cancer with its TG01 immunotherapy. RAS specific immune responses were induced in all 6 patients in Phase I, and no substantial side effects were observed in the patients. The clinical trial has now expanded from Norway to two sites in the UK.

 

Oslo Cancer Cluster member Targovax started in 2010 to develop targeted immunotherapy in the form of therapeutic cancer vaccines. The TG01 vaccine has been given as treatment to cancer patients, in combination with chemotherapy after surgery, to prevent relapse. TG01 is granted Orphan Drug Status for pancreatic cancer in both EU and USA. The promising Phase I results has triggered a $2M (12.5 MNOK) milestone from current owners.

 

Clinical trial in phase II
Gustav Gaudernack, professor emeritus at Oslo University Hospital, and one of the inventors of the technology, states: “I have great expectations for the principle of treating patients with peptide based immunotherapy, which educates the patients’ immune system to fight cancer. It is exciting that the TG01 project now reaches this important milestone in combination with chemotherapy”.

The clinical trial has now formally entered Phase IIa, and the trial is expanding from Norway to two sites in UK, namely The Christie NHS Foundation Trust in Manchester, and The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool.

UK Principal Investigator Professor Daniel Palmer says: “Vaccination targeting RAS mutations is an extremely promising area of research and with our considerable experience in conducting multicentre immunotherapy trials, we are looking forward to help expand Targovax’s TG01 trial into Phase IIa.”

Important milestone
CEO Hanne Mette Kristensen commented: “Through this important milestone, we have significantly reduced risk in TG01 development by confirming observations of specific immune response and safety for the patients. This is very encouraging. We will continue to work towards confirming the link between TG01 treatment and effect on survival for these patients. We are proud that the two UK sites now participate in the clinical trial – we see this as a quality mark. ”

Targovax’ RAS specific immunotherapy triggers both cytotoxic- and helper T-cell- immune responses, educating the patients’ immune system to recognize and kill the cancer cells.

New IPR is established as a basis for expanding pipeline to broader indications.

“Based on these results, Targovax is now focused on completing the ongoing Phase IIa study with TG01 in surgically resected cancer. In addition, the company is initiating preparations for a randomized Phase II, and completing a Phase I trial with TG02 in larger indications such as colorectal cancer and non-small cell lung cancer (NSCLC),” concludes Kristensen.

Read more in the press release on Targovax’ website.

 

About Targovax
Targovax develops immunotherapy in the form of therapeutic cancer vaccines. TG01 is being developed for pancreatic cancer as its first indication. The drug has been investigated in exploratory trials in patients with promising results. The company is located in Lysaker, close to Oslo, Norway.

TG01 and RAS
TG01 is a therapeutic cancer vaccine which means that it educates the body’s immune system to recognize and kill the cancer cells. TG01 is based on pioneering research into RAS mutations in the Norwegian Radium Hospital (now Oslo University Hospital) and Norsk Hydro. Mutation of RAS disrupts normal cell division signaling and contributes to development of cancer cells and tumors. RAS mutations are found in approximately 25% of all cancers and in particular in pancreatic cancer (80-90%), colorectal cancer (40%) and non-small cell lung cancers (30%). Lead candidateTG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase IIa trials in surgically resected pancreatic cancer, patients start treatment 1-8 weeks after surgery.

Pancreas cancer and other RAS-mutated cancer forms
Pancreatic cancer is a disease affecting 116 000 patients each year in EU and USA, and approximately 690 persons each year in Norway. Approx 15-20% of these are discovered at an early stage and are operable. The mortality is high, and the prognosis for these patients has been more or less unchanged the last 30 years. Approximately 80-90% of patients with pancreatic cancer have RAS mutations in the cancer cells.
RAS mutations are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.

Photo:

5 Oslo Cancer Cluster SMEs granted BIA-funding

The Norwegian Research Council recently granted BerGenBio, PCI Biotech, Lytix Biopharma, Oncoinvent and Ultimovacs –  all Oslo Cancer Cluster member companies – funding  through the Programme for User-Driven Research Based Innovation (BIA).

In total, the Research Council will grant a record amount of 444 million to 58 Norwegian companies over four years, of which 10 are biotech companies – which is also a new record.

BerGenBio, Lytix Biopharma, PCI Biotech, Oncoinvent and Ultimovacs will receive around 10 million NOK each over 4 years, depending on the outcome of the contract negotiations between the council and the company. Funding from the  BIA programme is a quality stamp since the companies compete in “open class” where all sectors are represented. The funding may also in turn trigger interest  from private investors.

On the Research Council`s website you may find the total list of all the 58 companies (in Norwegian) and read more about the funding from the BIA-programme.

Norwegian Cancer Society initiate investment fund

The newly employed Head of Biotech Investments in The Norwegian Cancer Society, Sigrid Fossheim, has already had several meetings with potential oncology companies to invest in. – We aim to make our first investment before the Summer of 2014, says Fossheim.

The Norwegian Cancer Society is the largest private contributor to cancer research in Norway. Annually the Society grants approximately MNOK 180 to cancer research.

Earlier this year the Norwegian Cancer Society announced they would start investing in early-stage companies and projects within oncology. Head of Biotech Investments Sigrid Fossheim, known from Oslo Cancer Cluster members as Epitarget and Clavis Pharma, has already had meetings with several companies and Tech Transfer Offices (TTO`s), hoping to tap into the available funding of MNOK 75 over five years.
Will make a difference
“We have some specific criterias for our investments of course, but for us the overall goal is to accelerate the development of new therapies and diagnostics for the benefit of the cancer patients. The rule of thumb when we invest is, that we will make a difference, meaning the funding should release the potential of a project and help the company through a critical phase where capital is scarce, says Fossheim

And adds: “A successful investment from our perspective implies that the company for instance has been able to undertake critical and risk reducing project activities rendering it more attractive to larger investors that can further finance the company to project commercialisation and patient benefit.”

As a general rule at least one co-investor should invest in the project or company in collaboration with the Norwegian Cancer Society.

“Having a co-investor is important for us in order to learn the do`s and don’ts of the trade. We have a tight dialogue with all actors in the field, both public and private, including the TTO`s,” says Ole Alexander Opdalshei, Deputy Secretary General.


Hope to inspire others to invest

The news that the Norwegian Cancer Society would start investing was very well received by the oncology community when the initiative was first announced in May this year. For the Society this is an entirely new role, and a very different role than funding cancer research, says Opdalshei.

“For us this is a political statement as well. We hope that through investing, the government and private investors understand that there is a huge need for capital to take oncology research from bench to bedside. We see too few promising projects reach the cancer patients, due to lack of funding in some critical phases. Hopefully our entry onto this scene will inspire others to take the leap – in collaboration with us,” says Opdalshei.

The Society will at the start of the 2014  have meetings with both Innovation Norway and the Norwegian Research Council, addressing the need for more early-stage funding in this area.

“We were very surprised and let down when we got the news that none of the governmental seed capital funds went to biomedicine. This is an area that deserves funding to transform the excellent research to actual patient care, says Opdalshei.

Contact us and set up a meeting
Fossheim encourages oncology start-ups and TTO`s that need funding, to contact her and set up a meeting for a first evaluation.

“If the company or TTO has a promising project that falls within the scope of the Society’s investment mandate, we will encourage the company/TTO to apply for investment funds, following some overall guidelines and providing the necessary documentation. If the evaluation of the company is positive with amongst other the fulfillment of the Society’s investment criterias – an investment proposal will be presented to the Investment Committee for recommendation. The board of the Norwegian Cancer Society will however have the final decision-making authority with regard to investments recommended by the Investment Committee, “says Fossheim.

Flowchart investment process Norwegian Cancer Society.

Facts – Norwegian Cancer Society`s Investments in Oncology:

  • MNOK 75 over a five-year period
  • Early-stage companies/projects
  • Investment criterias at an organizational level:
    1) Unlisted companies
    2) Main business area within oncology
    3) Well –organised and professionally run projects/companies
  • Investment criterias at a project level:
    1) Unique product with high potential for improved cancer care
    2) Unmet medical needs addressed
    3) Patent protection
    4) Competent and experienced team
    5) Proven capability in project execution
    6) Clear and achievable milestone plan
    7) Robust and suitable business model
    8) Low negative, reputation risk
    9) Conformity with the ethical guidelines of the Norwegian Cancer Society

Investment Committee members:

  • Terje Kalland, Chief Scientific Officer, Karolinska Development
  • Hans Peter Bøhn, physician and former healthcare analyst at Fondsfinans
  • Tom Pike, life science industry professional
  • Hilde Steineger, Head of Innovation Management, Pronova Biopharma
  • James Lorens, Professor at University of Bergen and co-founder of BerGenBio


For more information:

Contact Sigrid Fossheim, Head of Biotech Investments, The Norwegian Cancer Society: sigrid.fossheim@kreftforeningen.no /+ 47 982 38 465


About the Norwegian Cancer Society

The Norwegian Cancer Society is a nationwide organization that addresses the challenges of cancer and funding research is its main priority. The Society provides approximately 25 per cent of all direct funding for cancer research in Norway, and is also actively involved in cancer prevention and international collaboration.
The Society’s main goals are s to reduce cancer incidence, increase cancer survival and achieve optimal life quality for cancer patients and their families.
Read more on the Norwegian Cancer Society’s website.

 

BerGen Bio develops novel treatment for leukemia

Oslo Cancer Cluster member BerGenBio announce that preclinical studies on the agent BGB324 may be effective as new treatment for patients with drug resistant Chronic Myeloid Leukemia (CML). The data was presented in a poster at the Annual Meeting of the American Society of Hematology (ASH) early December.

It is estimated that CML accounts for approximately 10% of all new cases of leukemia. The disease originates from malignant stem cells in the bone marrow and ultimately spreads throughout the body developing into a rapidly progressive and almost uniformly fatal acute.

CML is now largely treated with targeted drugs called tyrosine kinase inhibitors (TKIs), which have led to improved long term survival rates and allow most patients to have a good quality of life when compared to the former chemotherapy drugs. Novartis’ Gleevec (imatinib) and Tasigna (nilotinib), and Bristol Myer Squibb’s Sprycel (dasatinib) are examples of these new targeted drugs.

Effective against drug resistance
However, long term therapy with the new treatment can result in the development of drug resistance and new mutations. BerGenBio’s preclinical in vivo studies shows that BGB324 may be effective as therapy taken alone, in leukemia and solid tumors, and is very effective in preventing and reversing acquired resistance to existing therapies.

The results are based on work conducted by Dr. Sonja Loges’ group at the University Comprehensive Cancer Center in Hamburg: “There is a significant unmet need for novel therapies that can address drug-induced resistant cancers”, comments Dr. Sonja Loges.

“The results of the preclinical studies support our belief that BGB324 could also offer a promising potential new treatment option for chronic myeloid leukemia, especially in patients that are resistant to the current standard of care.”

BerGenBio’s cancer drug BGB324 is the only selective Axl inhibitor in clinical development having recently completed a phase Ia clinical trial. Phase Ib clinical trials are planned in acute myeloid leukemia and non-small cell lung cancer in 2014.

Read the press release on BerGenBio’s website and the abstract in full on the American Society of haematology website.

About the Axl kinase receptor

Axl is a member of the Tyro3, Axl, Mer receptor (TAMR) tyrosine kinase family and is a fundamental receptor to cancer biology. It plays a crucial role in the epithelial-mesenchymal transition (EMT) which is a key driver of metastasis (cancer spread) and a mechanism of drug-resistance. The Axl receptor is regarded as one of the most promising new therapeutic targets for cancer drug development. BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase.

About BerGenBio AS
BerGenBio AS is a biopharmaceutical company located in Bergen, Norway and member of Oslo Cancer Cluster. The company is committed to developing first in class therapeutics that inhibit EMT, preventing the formation of cancer stem cells and disrupting the important mechanisms of acquired cancer drug resistance. The
company is founded on proprietary platform technology called CellSelect™, which uses information
from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is
the first compound in BerGenBio’s pipeline to enter clinical trials, with additional compounds and drug
targets at different stages of preclinical development.

Marketing authorisation for Bayer/Algeta`s prostate cancer treatment

Oslo Cancer Cluster member Bayer HealthCare announced Monday December 9th that they just received the marketing approval for Xofigo® (radium Ra 223 dichloride) by the Norwegian Medicines Agency. The approval came approximatelyone month after the European Commission granted marketing authorization in the EU for Xofigo® on November 15 2013.

Xofigo has been developed by Oslo Cancer Cluster member Algeta. In September 2009 Algeta signed an agreement with Bayer for the further development and commercialization of radium-223. Xofigo is produced in Norway at the Institute for Energy Technology (IFE) at Kjeller, just outside Oslo. The production plant opened in June 2013.

Bayer estimates that Xofigo will be available for Norwegian patients during the first months of 2014.

Xofigo was approved by the U.S. Food and Drug Administration in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.

 


Ny radioaktiv behandling utviklet i Norge forlenger livet hos pasienter med prostatakreft med spredning

Statens legemiddelverk har 9. desember godkjent en helt ny type  behandling av kastrasjonsresistent prostatakreft med spredning til skjelettet. Studien som ligger til grunn for godkjenningen, viser livsforlengende effekt og færre uønskede plager med det nye legemidlet Xofigo, sammenlignet med placebo.

Behandlingen skjer ved at radioaktiv stråling med alfapartikler ødelegger kreftcellene i  skjelettet uten å skade vevet rundt. Xofigo er forsket frem i Norge.

Hvert år rammes omtrent 4500 norske menn av prostatakreft, som er den vanligste kreftformen i  Norge. I de aller fleste tilfeller er det det mannlige kjønnshormonet testosteron som gjør at  svulstene vokser og sprer seg videre. Standardbehandlingen på alle stadier av sykdommen er  ofte hormonbehandling for å stanse eller hemme testosteronproduksjonen (kirurgisk eller  medisinsk kastrering).

Når eller hvis hormonbehandlingen ikke lenger gir noen effekt, kalles tilstanden kastrasjonsresistent prostatakreft. Da forekommer spredning til skjelettet i 70 prosent av  alle tilfellene. I Norge oppstår hvert år 700-800 nye tilfeller av spredning til skjelettet som følge av prostatakreft.

Ødelegger kreftcellenes DNA
Det nye legemiddelet Xofigo (radium Ra 223 diklorid) er det første kreftlegemiddelet som avgir  radioaktiv stråling i form av alfapartikler. Alfapartiklene virker innenfor en kort radius. Det gjør at  de dreper kreftcellene effektivt, samtidig som de ikke skader vevet rundt i samme omfang.

Legemiddelet Xofigo injiseres intravenøst og det søker seg så til områdene rundt svulstene i  skjelettet. Alfapartiklene dreper deretter cellene gjennom å forårsake permanente skader på cellenes DNA. Xofigo gis som injeksjon på sykehus en gang hver fjerde uke i seks måneder. Pasienten kan forlate sykehuset etter hver av de seks enkelbehandlingene uten spesielle restriksjoner.

Åtte norske sykehus har deltatt i studien
Den kliniske fase III-studien, ALSYMPCA, som ligger til grunn for godkjenningen av Xofigo, viser  økt levetid på 3,6 måneder for de pasientene som fikk Xofigo i forhold til de som fikk placebo. I  tillegg viser studien færre komplikasjoner fra skjelettmetastaser, som beinbrudd og tverrsnittslammelser hos de patienter som fikk Xofigo.

Åtte norske sykehus deltok i fase 3-studien ALSYMPCA, deriblant de største norske kreftklinikkene.

– Like viktig som overlevelsesgevinsten er etter min menig at radium-223 evner å forsinke komplikasjoner fra skjelettmetastaser. Pasientene vi har behandlet hadde mindre behov for  smertelindrende strålebehandling, færre beinbrudd pga. spredningen og ikke minst færre tverrsnittslammelser, alt sammen hendelser som reduserer livskvaliteten betydelig når de inntreffer. Vi har altså ikke bare sett en overlevelsesgevinst, men en klinisk veldig viktig reduksjon i antall komplikasjoner. Det kan spare pasientene for store lidelser og helsevesenet for betydelige  ressurser som ellers ville bli brukt til å behandle disse, sier Daniel Heinrich, overlege ved  Kreftavdelingen på Akershus Universitetssykehus.

Heinrich har behandlet 52 norske pasienter under studiene som ligger til grunn for godkjennelsen  av middelet, og er en av de legene i verden som har størst erfaring i bruk av Xofigo. I alt har 138 norske pasienter deltatt i studien.

Xofigo ventes tilgjengelig på det norske markedet i løpet av de første månedene av 2014.

MNOK 50 subscribed in Lytix Biopharma

Oslo Cancer Cluster member Lytix Biopharma AS has completed a successful issue that was subscribed shares of over 50 million NOK.

It was signed for in total 71,670 shares at a subscription price of NOK 700 per share. The company will, after the capital increase is registered in the ‘Business Register’, have 207 shareholders. CEO Unni Hjelmaas is delighted with Lytix Biopharma now having secured funding for the implementation of the company’s exciting plans within infection and cancer research through 2014.

“We are pleased with the interest the company has been shown in the challenging capital market”, says the chairman Knut Eidissen.

Lytix Biopharma’s board considers listing the company on the Oslo Stock Exchange, including the optimal time for this, and what type of listing which is most suitable.

Lytix Biopharma includes first patient in cancer study
The company recently started the recruitment of patients in a new clinical study of its cancer drug candidate LTX-315, targeting various kinds of cancerous tumors. The objective of the study is to demonstrate that LTX-315 is safe and activates the patient’s own immune system to kill cancer cells, a treatment called Immunotherapy. Up to 80 patients will be enrolled in the study, which is expected to be completed within 2015.

Lytix Biopharma’s CEO Unni Hjelmaas says, “This is a milestone in the development of the LTX-315. The study will demonstrate if the immunotherapy can be documented in cancer patients. We are pleased that the first patient is recruited at Oslo University Hospital – the Norwegian Radium Hospital”.

This study will include patients with different types of cancerous tumors located just under the skin. Four cancer hospitals in Europe are participating in the study – Oslo University Hospital – the Norwegian Radium Hospital (Norway), Jules Bordet and St. Luc (Belgium) and Guy’s Hospital (UK). The study is approved by the health authorities and ethics committees in the respective countries.

Lytix Biopharma’s cancer drug candidate has the potential to be a novel cancer immunotherapy. Immunotherapy is expected to induce the long-term survival due to the durable immune response. Preclinical data has shown that direct injections of LTX-315 into tumors mobilizes the immune system to kill cancer cells (see the video here) and prevent recurrence of cancer. Immune activation and shrinkage of treated tumors were observed in a first clinical study with LTX-315 in patients.

About Lytix Biopharma
Lytix Biopharma AS develops novel drugs for the treatment of resistant bacterial and fungal infections, as well as first-in-class oncology treatments. The Lytix anti-cancer drug is a mimetic of membrane-active host defence peptides and causes tumor necrosis and release of danger signals leading to an induction of anti-tumour immune responses. Lytix is developing synthetic peptides that take advantage of the characteristics of the innate immune system to produce an entirely new class of cancer therapeutics.

In the issue the following insiders have been allocated shares:
Picasso Kapital AS, controlled by chairman Knut Eidissen, 5760 shares
Steinar Hoeg, Director, 1,200 shares
Unni Hjelmaas, CEO 143 shares

Fazenda Securities has been the advisor and lead facilitator of this issue, and Sparebank1 Market has been co-facilitator.

Photo: Cancer Cell, Gerd Berge, UiT.

Bayer with marketing approval in EU for Algeta-developed drug

Algeta and Bayer have received marketing authorisation from the European Commission for Xofigo® for the treatment of prostate cancer patients with  bone metastases.

The marketing authorization provides approval for the commercialization of Xofigo in all 28 countries of the EU, and in Norway, Iceland and Liechtenstein following national approval. This decision follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September of this year.

Major milestone for Algeta

Andrew Kay, Algeta’s President & CEO, said: “Today’s decision by the European Commission to approve Xofigo in the EU is another major milestone achieved for Algeta. It marks the start of what we hope will become an important royalty stream based on Bayer’s ex-US sales, in addition to the 50% share of the profits we expect to receive from the co-promotion of Xofigo in the US. Our partnership with Bayer is proving to be very productive and we are delighted with the progress being made.”

“Prostate cancer is the commonest cancer in men, and often spreads to the bones,” said Christopher Parker, MD, Principal Investigator of the ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, and Honorary Reader in Prostate Oncology at The Institute of Cancer Research, London.

“Bone metastases lead to pain, fracture and other complications that can significantly impair the patient’s health and well-being. Xofigo targets bone metastases, delivering a localized effect to offer patients prolonged survival, making it an exciting advance in the treatment of this cancer.”

About Xofigo® (radium Ra 223 dichloride)
Xofigo® is an alpha particle-emitting pharmaceutical. Xofigo’s active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect.

Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy. The alpha particle range from Xofigo is less than 100 micrometers (less than 10 cell diameters), which minimizes damage to the surrounding normal tissue.

Xofigo is approved in the US for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of radium-223. Under the terms of this agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer’s sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US.

About Algeta

Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock
Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.

 

Oncoinvent, Lytix and PCI granted funding

Three Oslo Cancer Cluster SME`s emerged as the winners of the Immuno-Oncology Innovation Call. Oncoinvent was as a clear number one of the 10 applications received.

For the first time Oslo Cancer Cluster had the opportunity to grant funding to collaborative innovation projects under the NCE Program’s “Innovasjonsrammen”. Oncoinvent, Lytix Biopharma and PCI Biotech submitted the three winning proposals that have been selected among a total of 10 relevant and interesting projects.

A clear favorite
Oncoinvent applied for funding to evaluate the therapeutic potential as well as possible side effects of a new drug candidate (OI-3 antibody) in preclinical studies. The application emerged as a very clear favorite among the expert panel; and the Oncoinvent team will receive NOK 500.000 to move this forward.

The expert panel consisted of the following: Hans Peter Bøhn from Fondsfinans, Anders Sundan from NTNU, Steinar Funderud from Oslo University Hospital, Radium Hospital and Ole Johan Borge from Innovation Norway.

The expert panel ranked Lytix Biopharma’s and PCI Biotech’s project as number 2 and 3 and proposed to fund these with NOK 250.000 each. The Board of Oslo Cancer Cluster fully agreed with the experts in the Board meeting on October 29 2013. Innovation Norway will enter negotiations with the three winning teams so that the projects can start during this year.

Innovation potential
Tina B. Bønsdorff, CEO of Oncoinvent was very glad to hear about the outcome: “We are very pleased and honoured that Oncoinvent’s project is the first choice of the nomination committee. This will have a significant impact on the activity of our company in 2013-2014.”

Also CEO of Lytix Biopharma Unni Hjelmaas expressed her joy: “This is a very positive surprise indeed. This grant will definitively contribute to realizing the project.”

Oslo Cancer Cluster will now follow up this pilot funding scheme with Innovation Norway and the NCE Program.

“The number of quality of applications received in this call indicates clearly the innovation potential within the cluster. We hope that the NCE Program and Innovation Norway will further evolve this important novel funding scheme,” says Jutta Heix, International Advisor of Oslo Cancer Cluster and Project Coordinator for the Norwegian Immuno-Oncology Consortium.

About the funded projects:

Oncoinvent project:
The project shall evaluate the therapeutic potential as well as possible side effects of a new drug candidate: OI-3 antibody through pre clinical studies. The project shall also secure a better and broader IPR for the drug candidate.

Lytix Biopharma project:
The project shall identify and explore immunological factors that are present before treatment with Lytix`anti-cancer product LTX-315.The project would also like to explore the potential side effects and toxicity of LTX-315 in the liver.

PCI Biotech project:
The project seeks to generate new IPR for the use of Photochemical Internalisation (PCI) within immune therapy and vaccination. The project also aims to demonstrate that the technology may be used to elevate the cytotoxic T-cell response in vitro and in vivo when applied within immune therapy.

 

 

 

Investinor and Industrifonden invest in Pharmalink

Oslo Cancer Cluster was the proud host of a press conference in early October, where two of the Nordic region’s largest governmental venture investors Investinor and Industrifonden announced their NOK million 90 investment in Swedish biotech Pharmalink. Pharmalink is a specialty pharma company focused on orphan and niche products within cancer and renal disease.

The press conference was hosted by Oslo Cancer Cluster due to Pharmalinks future plans of joining the cluster and becoming a part of the strong oncology environment in Oslo.

Jónas Einarsson, acting director of Oslo Cancer Cluster states “I am very glad to hear that Pharmalink would like to join Oslo Cancer Cluster and I welcome them to be a part of our strong member organization. I am also very happy for the collaboration between Investionor and Industrifonden within biotech, and hope for more co-investments in the close future.”

This is the second co-investment Investionor and Industrifonden have made in collaboration, the first one was also in biothech: Norwegian company Smartfish that produce nutraceuticals for cancer patients among others.

In the picture from the press conference you see from the left Investment director from Investinor og member of the board of Pharmalink Ann-Tove Kongsnes, CEO of Investinor Geir Ove Kjesbu, CEO of Industrifonden Claes De Neergaard and CEO of Pharmalink Johan Häggblad. Photo: Anne-Elisabeth Næss.

Below the facts you may read the press releases from both Investionor (In Norwegian) and Pharmalink (In English) on the investment:

Facts:

About Pharmalink
Pharmalink is a Swedish specialty pharma company developing high value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical development and marketing to identify and progress products that address significant unmet medical needs. With a successful history in pharmaceutical sales and marketing, and highly experienced, dynamic management team, Pharmalink is focused on the development and commercialization of valuable, de-risked projects. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™. Pharmalink is actively seeking opportunities to acquire or in-licence product opportunities in niche and hospital care indications. Visit www.pharmalink.se for further information.

About Industrifonden
Industrifonden is one of Sweden’s largest and most experienced investors at early stage and in growth companies and manages an evergreen fund of approximately 3.5 billion (EUR420m). It has for the last 30 years had a leading role in the development of Swedish life science companies. Founded by the Swedish government in 1979, Industrifonden is an independent venture capital fund that operates on a strictly commercial basis and receives no further government funding. Revenues are returned to the business for new investments. See more info at: www.industrifonden.se

About Investinor
Investinor is Norway’s largest investor in venture and expansion capital, and manages a NOK4.2 billion (EUR525m) evergreen fund. Investinor was founded in 2008 and is funded by the Norwegian government. It invests directly in promising unlisted companies and on the same terms and conditions as private investors, with a clear exit strategy for all investments.
Find more info on: www.investinor.no