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.

 

Excellent evaluation of Oslo Cancer Cluster

The six year evaluation of Oslo Cancer Cluster as a Norwegian Centre of Expertise concludes that Oslo Cancer Cluster is a strong biotech cluster, well positioned within the global oncology industry. “This plays well with our ambition to take the step up a level and become a Global Centre of Excellence,” says Jónas Einarsson, acting CEO of Oslo Cancer Cluster.

The thorough evaluation report gives a comprehensive picture of the Oslo Cancer Cluster as of today; our projects and plans and also our achievements over the last three years since our first evaluation in 2010. Both evaluations have been done by Oxford Research.

Evaluation of Oslo Cancer Cluster NCE after 6 years.
Evaluation of Oslo Cancer Cluster NCE after 3 years.


Bottlenecks have been identified and reduced

“The evaluation points out that Oslo Cancer Cluster from 2010-2013 have managed to address the challenges for oncology R&D in Norway as well as the weaker points from the first evaluation. We have identified some crucial bottlenecks within clinical trials, and contributed to reduce the pre-clinical development time for oncology start-ups. We have also made it easier for SME`s to attract the capital they need to develop new oncology treatment. This I am very proud of”, says Jónas Einarsson, acting CEO of Oslo Cancer Cluster.

Einarsson continues: “All in all we have received an excellent evaluation. The evaluation concludes that we have untapped innovation potential, and that we need to address this issue in the years to come. This is totally in line with what we plan to do through the work with the Oslo Cancer Cluster Innovation Park and the Oslo Cancer Cluster Incubator.”


Well positioned to become a Global Centre of Expertise

The public cluster program in Norway has until now included two levels; Arena and Norwegian Centre of Expertise. In 2014 a third and higher level, the Global Centre of Expertise (GCE) will be introduced. Only mature clusters with a global position will obtain the elite status as a GCE and probably only 4-5 clusters will be chosen.

“Oslo Cancer Cluster`s ambition is to become one of these 4-5 GCE-clusters. The evaluation shows that we are a global player in the oncology field, and that we have succeeded in establishing an extensive international network that exposes the members for the global oncology industry and secures that recourses like capital and competence are accessible,” says Einarsson.

Einarsson points out that the three years to come will take the cluster a giant step further on the global scale with a targeted focus on innovation: “In 2015 Oslo Cancer Cluster Innovation Park opens and this will become a power centre for oncology R&D. The Oslo Cancer Cluster Incubator will make sure that we have new commercialization’s from oncology research. These new start-ups will have better frame work conditions to succeed than ever before. Oslo Cancer Cluster has since the start managed to build a solid fundament. In many ways the cluster has just begun its work.”


Other conclusions from the evaluation:

  • Particularly strong topics within Oslo Cancer Cluster are personalised medicine and immuno-oncology. These are also the buzzwords on the global oncology scene, which makes the cluster well positioned and attractive as a collaborative partner.
  • The cluster have increased the number of members considerably and in parallel developed into a national cluster representing the entire oncology-value chain from bench to bedside.
  • There is now a considerably degree of trust between the members which is based on regular networking and collaboration across disciplines.
  • The strategy work performed during this three-year period have been of good quality and have been embedded in a god way.
  • The feedback from the members on the importance of Oslo Cancer Cluster for their company, institution is to some extent a bit weaker in 2013 than 2010. We take this very seriously and will take action and see how we may perform better here.

 

 

Two Oslo Cancer Cluster Board members receive K.G. Jebsen funding

Despite keen competition from other outstanding medical research groups, Oslo Cancer Cluster Board members Professor Ragnhild A. Lothe and Professor Rolf Bjerkvig have won the competition for funds for new K.G. Jebsen centres in the field of medicine – a long side John-Bjarne Hansen. 


By giving NOK 16 million to each of the three new centres, the Kristian Gerhard Jebsen Foundation wants to give a real boost to research and, not least, to contribute to excellent medical research benefiting patients sooner. In addition to the grants from the Foundation, each centre will also be allocated a substantial sum by its own institutions.

Focus on cancer research
It is worth noting that two of the new centres this year are cancer research centres. The centre at the University of Bergen led by Rolf Bjerkvig works on cancer of the brain, with particular focus on translating research results from laboratories into patient treatment. The centre is a collaboration between several research groups and hospital departments, and it is part of an international research network based in Luxembourg.

Ragnhild Lothe’s centre at Oslo University Hospital aims to develop better diagnostic and treatment methods for rectal cancer, and to help to improve hospital efficiency and benefit patients. Lothe believes that the establishment of a dedicated centre could encourage more young doctors and researchers to take an interest in this serious form of cancer, which is actually the second most common form of cancer in Europe and is currently only survived by around half the patients.

Of the 14 K.G. Jebsen Centres for Medical Research that will have been established in 2014, five work on cancer-related research. In a competition in which the primary criterion is quality, this is an indication that Norwegian cancer research is already at the forefront of the field, also in the international context

The new centre for medical research that is led by John-Bjarne Hansen will work on venous thromboembolism (VTE), which is a generic term for cardiovascular problems that affect almost 10,000 Norwegians every year.

Two of five focused research areas at Oslo University Hospital to cancer
As well as the K.G. Jebsen Centre – Professor Ragnhild Lothe also received one of five “Focused Research Areas at Oslo University Hospital 2014 – 2018”  for the colorectal SMART project.

Her research colleague Arne Kolstad, also received this appointment for his project within Cancer Immunotherapy, where both the Section for Cell Therapy and The Section for Immunology are major partners.

This clearly shows the strength of the cancer research performed at the Oslo University Hospital, when two of five focused research areas that will run in the next four years, goes to cancer.

Read more on this here (only in Norwegian).


Read more:

Ragnhild Lothes group.

Rolf Bjerkvigs group.

Arne Kolstads group.

Facts about the Kristian Gerhard Jebsen Foundation:
The Foundation was established in order to honor the memory of shipping magnate Kristian Gerhard Jebsen and his contribution to Norwegian and international shipping and business. The Foundation was established by Jebsen’s wife Aud Jebsen and the family in 2009.  At the turn of the year 2012/2013, the Foundation’s equity was NOK 916.6 million. Since the Foundation was established, it has awarded a total of NOK 324 million, NOK 274 million of which to Norwegian research. Further information about the foundation is available at the web site: www.stiftkgj.no

 

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.

Helsemyggordning – financial instrument for health innovation

December 11th 2013, Oslo Cancer Cluster, Oslo Medtech and Nansen Neuroscience Network launched a proposal for a new financing mechanism to stimulate innovation from the health- and biotech industry.

The proposal was very well received among the politicians, industry, public organisations and investors at the debate meeting in conjunction to the launch. Conservative Member of Parliament Kristin Vinje viewed the scheme as an exciting proposition that it is worthwhile to investigate further.

The three health clusters have named the scheme “Helsemyggordning”, building on a similar financial instrument from the oil and gas industry that was established to encourage exploration and development activity among young and small petroleum companies.

To stimulate increased health innovation, the scheme “Helsemyggordning” would involve cash payments of tax deduction related to the cost of development and testing of health products and health technologies innovators who are not liable to tax. When the company gets profits and are liable to tax, they must repay the tax paid for the development and testing costs. The system thus acts as an interest-free capital loans from state to the health innovations.

Acting CEO in Oslo Cancer Cluster, Jónas Einarsson, says the scheme may  trigger the huge potential within Norwegian health R&D. “We are at a critical stage now, as the biotech projects coming out are more mature and in a need for early funding,” says Einarsson.

Menon Business Economics have analysed “Helsemyggordningen”. They conclude that it is easy to administrate, predictable, and targeted.

Please find more in debth information here:

Report on “Helsemyggordningen”

Presentation of Helsemyggordningen, by Erik Jacobsen, Menon Business Economics.

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.

Horizon 2020: Major possibilities

Horizon 2020 is the new European Framework Program for Research and Innovation. Oslo Cancer Cluster encourage our members to take a closer look at the possibilities Horizon 2020 represents for funding R&D oncology projects and also taking part in international networks.
Norwegian participation in the EU framework programs has been of critical importance to Norwegian research, enabling Norwegian researchers, research institutions and companies to take part in larger international networks.

The Norwegian Research Council has recently been touring most of Norway hosting information meetings on Horizon 2020. The program will take effect from January 2014 and the budget is of around 70 billion Euros over a seven year period. This is a large increase from the last framework program.


Horizon 2020 incorporates three overall areas of funding – and there is a specific focus on SMEs and also on academic-industry collaboration within the program:

  • Funding for basic research to support curiosity-driven, innovative research and large-scale cooperation on research infrastructure
  • Funding to strengthen industrial leadership and competitiveness with the help of effective industry-oriented funding instruments
  • Funding for research and innovation activities to solve shared societal challenges

Under the topic “Health, demographic change and wellbeing”, there are seven focus areas:
1. Understanding health, ageing & disease
2. Effective health promotion, disease prevention, preparedness and screening
3. Improving diagnosis
4. Innovative treatments and technologies
5. Advancing active and healthy ageing
6. Integrated, sustainable, citizen-centred care
7. Improving health information, data exploitation and providing an evidence base for health policies and regulation

More information may be found here:
The Norwegian Research Council webpage
Draft Work Programs 2014-2015
Newsletter – Program for Health, demographic change and wellbeing

Important deadlines:

  • Horizon 2020 national launch events: October 2013 to January 2014
  • Adoption of work programme and publication of first calls for proposals: December 11 2013
  • Expression of interest: Medio January 2014

 Background material presented by the Research Council on the information meeting in Oslo in November 2013:

Inven2 strike major deal

Inven2 grants exclusive worldwide license to its epidermal growth factor receptor (EGFR) inhibitors patent portfolio to Merck. Researchers and clinicians at Sørlandet Hospital have discovered that the EGFR inhibitors may play a vital role as a pain reliever for so called neuropathic pain. This is a potential novel use of the growth factor inhibitor that up until now have been used in cancer treatment, stagging cancer growth.

 

Inven2 AS, the entity commercializing early stage inventions from the largest University and Hospitals in Norway, announced on November 22 2013, that an exclusive worldwide license agreement was signed with Merck for its patent portfolio related to a potential novel use of EGFR inhibitors in the treatment of neuropathic pain.

“We are encouraged with the progress of our ongoing exploratory clinical trials and are excited about further investigating EGFR inhibitors for this use,” says investigator Dr. Christian Kersten at Sørlandet Hospital.

 

One of Norways largest biotech deals
Under the agreement, Inven2 will get an upfront payment from Merck, and potentially receive a total of € 100 million in development milestones depending on the number of EGFR inhibitors being launched. In addition, Merck will pay Inven2 tiered royalties on net worldwide sales. In exchange, Merck will gain exclusive worldwide rights to develop and commercialize the portfolio. This means that this is one of the largest biotech deals ever made in Norway at this point.

“We believe that Merck is an ideal partner for us as they are clearly committed to take the lead position in the EGFR inhibitor drug class segment, and they have a profound knowledge of this area. This agreement validates the high potential the drug class has in new indications driven by their high unmet medical need,” said Ole Kristian Hjelstuen, CEO of Inven2

 

About Inven2 – Oslo Technology Transfer
Inven2 is the technology transfer office for the University of Oslo, Oslo University Hospitals and all hospitals in the South-East region of Norway. Inven2’s mission is to turn excellent science into products mainly in the field of life sciences.

The various institutions together, disclose around 200 unique inventions annually. In 2013, Inven2 is on plan to deliver 60 new patent filings, 35 license agreements, and 5 start-up companies. As of today Inven2 has a portfolio of 27 technology start-ups and a range of licensing agreements with the discovery of the biomarker NT-proBNP (Elecsys “Roche”) as the biggest commercial success at present.

Inven2’s other business area is clinical contract partnerships with the Oslo University Hospital and South-Eastern Health Municipal.

For more information, please visit www.inven2.com

Photo: The team of doctors at Sørlandet Hospital that have discovered the novel use of EGFR inhibitors, together with the life science team from Inven2 securing the deal with Merck.

 

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.

 

 

 

Norwegian Cancer Society grant MNOK 160

The 2013 year’s grant to cancer research in Norway, 160 million NOK (EUR 20 M) is the largest grant the Norwegian Cancer Society has ever given.

“It is fantastic that we are able to provide such a large amount to our top cancer researchers in Norway”, says Secretary-General Anne Lise Ryel, Norwegian Cancer Society. “This is made possible thanks to our big and small, but always generous donors and members”.

The money will be divided among 121 projects at 12 research institutions across the country. The three institutions that will receive the most are: Oslo University Hospital (MNOK 73), the University of Oslo (MNOK 35) and the University of Bergen (MNOK 24). Download a full overview over the projects here (in Norwegian).

Enables quality boost
For Oslo Cancer Cluster member NTNU, the Norwegian University of Science and Technology, the grants constitute a significant contribution to the university’s cancer research: “The money enables us to boost the quality of our research”, says Dean Stig Slørdahl from the Faculty of Medicine. “It was a great joy to receive this funding, especially when we know that only the best projects receives funding.”

One of the cancer researchers at NTNU that got funding for here project is Bodil Merete Kavli, whom you can read more about in the Cancer Society’s blog. She’s trying to find out which mechanisms inside the cells causes the development of lymphoma cancer. Thanks to the award from the Cancer Society, Kavli is now able to finance a four year research position.

About The Norwegian Cancer Society
The society is the largest non-government sponsor of independent cancer research in Norway. Over the last 10 years the Norwegian Cancer society  has granted 1.6 billion NOK (EUR 2bn) to cancer research. This represents over 25 prosent of total resources Norwegian researchers have at their disposal for their research. Read more here: www.kreftforeningen.no

Pucture: Cancer researcher Bodil Merete Kavli at NTNU, surprised by the Cancer Society and Norwegian Television. Photo: Arild Domaas, NCS

Pleased with the political platform

The new government of Norway has launched their political platform. Oslo Cancer Cluster have reviewed the political platform document. We are overall very pleased with the initiatives that concerns research, knowledge, education, business and R&D.

Jónas Einarsson, acting director of Oslo Cancer Cluster says “There are a lot of initiatives in this political platform from Høyre and Fremskrittspartiet which is directly in line with Oslo Cancer Cluster`s strategy and areas we have been working on for a long time. Some of these are crucial for building a strong biotech industry in Norway at the same time as we take care of the cancer patients and develop the cancer treatments of tomorrow.”

These are some of the plans we highly agree with:

  • Norway should become one of the most innovative countries in Europe
  • More funds to industry R&D and innovation
  • Use industry clusters as an innovation tool – by especially strengthen the Norwegian Centres of Expertise (NCE-program) and start up Global Centres of Expertise.
  • More resources to governmental seed capital funds
  • Secure more funding to clinical trials as well as increase the number of patients participating in clinical trials
  • Develop an activity plan for the national strategy for cancer

Here you may download the polticial plattform from Høyre and Fremskrittspartiet.

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

Life Tech & Novartis to develop immunetherapy against leukemia

Life Technologies Corporation has signed a long-term supply and exclusive licensing agreement with Novartis for immunotherapeutics involving T cells modified to express chimeric antigen receptors for the treatment of cancer. Both Novartis and Life Technologies are member of Oslo Cancer Cluster.

Life Technologies (former Dynal) will provide the company’s proprietary technology, Dynabeads® CD3/CD28 CTS™, which possess unique biological properties suited to production of active, therapeutically relevant immune system cells. The agreement includes rights to use Life Technologies’ intellectual property to perform the resulting therapy, and is exclusive for use in the field of chimeric antigen receptors for the treatment of cancer.

“The collaboration with Novartis highlights the distinct capabilities that Life Technologies can provide in the therapeutic realm,” said Greg Lucier, chairman and chief executive officer of Life Technologies. “Taken with our previous announcements of companion diagnostic collaborations, the current agreement demonstrates how Life is uniquely positioned to facilitate drug development through alliances with pharma.” Chimeric antigen receptor T cell based immunotherapy constitutes a novel, individualized method of combating cancers.

Immunotherapeutic treatment of child leukemia
Novartis is working to commercialize technology developed at the University of Pennsylvania that has demonstrated startling efficacy in research studies. In two 2011 publications University of Pennsylvania researchers described application of immunotherapy in three patients, all of whom experienced durable complete or partial remission of their cancers within three to four weeks of treatment. A 2013 publication in the New England Journal of Medicine described complete responses with one ongoing in two children with leukemia.

The personalized therapy consists of removing blood cells from cancer patients; isolating and activating T cells; genetically modifying the T cells thereby programming those cells to recognize and attack cancer cells; expanding the T cells; and, lastly, introducing those cells back into the body so the patient’s immune system can take over. Under the terms of the current agreement, Life Technologies’ Dynabeads® CD3/CD28 CTS™, will be used to isolate, activate and expand the T cells.

“Dynabeads ® CD3/CD28 CTS™ have unique properties that are ideal for producing a robust immunotherapeutic,” said Oystein Aamellem, head of Cellular Medicine at Life Technologies. “Not only do the beads assure that T cells are separated from any unwanted cells, it also triggers the T cells to reproduce in a natural and controlled manner, ensuring a therapeutically relevant population is transferred back into the patient.”

Read an article about one of these children featured in the New York Times here.

 

 

Logo Ockham Oncology

Fully integrated oncology partner

Now in its fourth year as a member of the Oslo Cancer Cluster, Ockham Oncology unveils its stronger global oncology expertise, as a fully integrated, pure oncology-focused international partner.

Operating at full strength following a 2012 merger with U.S.-based Ockham Oncology, the combined company is continuing to strengthen its partnerships within the Oslo Cancer  Cluster by focusing on Ockham’s long-term, successful clinical record of managing hundreds of oncology clinical trials in all phases of cancer-drug development worldwide

Ockham Oncology’s Chief Scientific Officer Clare Wareing, Ph. D., who founded Nexus Oncology, said the new stronger company is the only pure oncology CRO operating around the globe. “We have been a successful partner with many members of the Oslo Cancer Cluster over the years,” Dr. Wareing said. “We look forward to future relationships as a result of our increased global capability and the addition of a specialist oncology biometrics team under the Ockham Oncology identity.”

Dr. Wareing said the company’s track record of working on complex, early phase studies will be attractive to OCC members. “We remain purely oncology focused,” Dr. Wareing said. “It’s my passion and I have dedicated my career to oncology,” she added. “As we have grown, Ockham has attracted specialized personnel who are highly respected in their own field. As Ockham Oncology, we have enhanced our global capability and retained the specialist oncology expertise to manage more innovative and complex studies,” Dr. Wareing noted.

Dr. Wareing said the R&D meetings bring together a blend of outstanding speakers and great science. “We look forward to engaging our partners as we expand our operations in Norway,” she added. The Ockham and Nexus combination, completed in January 2012, created the largest privately held oncology CRO in the world. The merger brought together talented oncology researchers as well as well-known success in biometric analysis and data management.

Dr. Wareing addressed the new company and its expertise during an interview with PharmaTV.  Click here to view the interview. During the Pharma Television interview, Dr. Wareing highlights global strengths of the fully integrated company. The video, “Ockham Oncology’s CSO highlights global strength of fully integrated company,” is about 10 minutes in length.

Since 1986, Ockham Oncology has conducted hundreds of oncology trials across all phases of development, including pre-clinical preparation, to bring innovative oncology therapies to the market. Through the 2009 acquisition, the Ockham CRO strengthened its oncology expertise. Following a second acquisition in 2012, Ockham enhanced its reputation as an oncology CRO as well as its global footprint.

About Ockham:
Launched in 1986, Ockham is a global oncology CRO and full-spectrum global resourcing company. Clinical expertise, therapeutic focus, and successful oncology trial outcomes have created an industry leadership position for Ockham Oncology. Ockham Source continues to achieve sustained success by offering traditional sourcing solutions as well as a growing FSP (Functional Service Provider). Ockham’s world headquarters is based in Cary, North Carolina, with the European headquarters located in Roslin, Scotland, near Edinburgh. Ockham offices are located strategically around the world to serve global customers.

 

National Cancer Drugs Fund

Oslo Cancer Cluster, the Norwegian Cancer Society and the Association of the Pharmaceutical Industry in Norway join forces in pushing for a new cancer drugs fund. The purpose of the fund is to ensure equal and quicker access to new approved cancer drugs in Norway.

 

A cancer drugs fund would cover the costs of new cancer drugs for public hospitals over a period of two to three years, and would ensure that cancer patients in Norway are given equal and quicker access to new cancer drugs. The fund provides an opportunity to generate Norwegian data regarding the effects of cancer drugs and obtain experience of their use in Norwegian hospitals. This would give the pharmaceuticals authorities a good basis for evaluating the value of each drug and give time for a thorough assessment of whether we want to start using it in Norwegian hospitals.


Equal and quicker access

There are two pressing reasons why such a cancer drugs fund should be established:
Firstly, it will ensure that the same cancer treatments will be available all over Norway. This is not the case today. Secondly, a national cancer drugs fund will ensure that new cancer drugs are taken into use immediately after being approved by the Norwegian Medicines Agency and recommended by expert groups, regardless of health economics and bureaucratic processes.


We want this now because:

Growing knowledge about cancer and cancer treatment results in new medical advances being made all the time. The Norwegian funding scheme for cancer drugs has proven to be poorly equipped to deal with the continuous development and innovation in this area, for two main reasons: Firstly, drugs are funded over the hospitals’ operating budgets, which means that expensive new cancer drugs are not followed up by fresh money in the hospital budgets. Secondly, the Norwegian health authorities often take a long time to consider whether to introduce new drugs in the treatment guidelines, even after a drug has been thoroughly assessed and approved for use by international and Norwegian pharmaceuticals authorities and recommended by oncology expert milieus.

 

In Norwegian:

Oslo Cancer Cluster, Kreftforeningen og Legemiddelindiustriforeningen går sammen inn for et kreftmedisinfond.  Formålet med fondet er å sikre lik og raskere tilgang til nye, godkjente kreftmedisiner i Norge.

Et kreftmedisinfond vil gi offentlige sykehus kostnadsdekning for nye kreftmedisiner over en to-  til tre-års periode og vil sikre kreftpasienter i Norge lik og raskere tilgang til ny kreftmedisin. Fondet gir mulighet til å generere norske data for effekt og samle erfaring fra bruken av legemiddelet ved norske sykehus. Dette vil gi legemiddelmyndighetene gode forutsetninger til å evaluere verdien av hvert enkelt legemiddel og gi tid til en grundig vurdering av om vi ønsker å ta det i bruk på norske sykehus.

Lik tilgang og raskere tilgang
Det er to svært presserende grunner til at et slikt kreftmedisinfond bør komme på plass:
For det første vil dette samme kreftbehandling over hele landet. Det er ikke realiteten i dag. For det andre vil et nasjonalt kreftmedisinfond sikrer at nye kreftmedisiner tas i bruk umiddelbart etter godkjenning fra Legemiddelverket og anbefaling fra faggruppene, uavhengig av helseøkonomiske og byråkratiske prosesser.

Bakgrunnen for at vi ønsker dette nå:
Økende kunnskap om kreft og kreftbehandling, fører til stadig nye medisinske fremskritt. Det norske finansieringssystemet for kreftmedisiner har vist seg lite egnet til å håndtere den kontinuerlige utviklingen og nyvinningene innen dette området, basert på to sentrale problemstillinger: For det første er finansieringen av legemidlene lagt til sykehusenes driftsbudsjetter, det innebærer at nye og kostbare kreftmedisiner ikke følges opp med nye penger på sykehusbudsjettene. For det andre bruker norske helsemyndigheter ofte lang tid på å vurdere om nye medisiner skal få en plass i behandlingsretningslinjene, selv etter at medikamentet er grundig vurdert og godkjent for bruk av internasjonale og norske legemiddelmyndigheter og anbefales av de onkologiske fagmiljøene.