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.

Juice with Omega-3 can become new cancer treatment

Professor Per Kogner (picture) and his research team at Karolinska Institute in Sweden have found that omega-3 fatty acids inhibit cancer growth. Now in a new study children who have had cancer are receiving supplementation of the fatty acids.

Experiments at the Karolinska Institute is already in full swing. Several years ago, Per Kogners research team saw that omega-3 fatty acids kill cultured cancer cells. Now a group of children who have finished cancer treatment have been selected for inclusion in a clinical trial. They get supplementation of omega-3 fatty acids (DHA and EPA) in the form of a juice based nutritional drink containing a high dose of Omega 3 every day for three months. In phase one, researchers will determine the dose that is right, then with longer treatment during phase two, they will study the effects omega-3 have on late complications and cancer recurrence.

See the movie about Per Kogners research

– We know from other studies that supplementation with omega-3 fatty acids are good for brain development and that those who eat a diet high in omega-3 are more rarely affected by cancer. Our own research shows that omega-3 fatty acids inhibit the growth of both neuroblastoma and medulloblastoma. Now we go on to see how large doses are needed and how they affect the children, says Professor Per Kogner.

Reduce the risk of relapse and complications
The purpose of the study is to see if supplementation of omega-3 fatty acids may reduce the risk of relapse in the disease and also if the children feel better when drinking the juice with the fats. The researchers also want to see if complications after treatment can be reduced by using the supplement since it is previously shown that these fatty acids promotes the vision, behavior, heart and blood pressure and brain development.

– We have reason to believe that omega-3 fatty acids may reduce the risk of relapse and improve the child’s health, immune system, nutrition, cognition and quality of life. Other researchers have found that omega-3 fatty acids improve the condition of children with ADHD and dyslexia and therefore it is important to test our hypothesis in children with cancer, says Per Kogner.

The reason for the hypothesis that omega-3 fatty acids work for children who have had brain tumors or neuroblastoma, is exactly where the tumors arise.

– Neuroblastoma is a cancer of the peripheral nervous system, medulloblasom in the central nervous system. Nerve tissue contains more fat than any other tissue in the body and is dependent on addressing the omega-3 fatty acids that we eat. In our previous experiments, we have seen that the implanted nerve cell tumors grow smaller and occur less often if you eat a diet that is enriched with omega-3, particularly DHA. Complications affecting the brain or metabolism also occurs in children with other cancers, so they will also be included in the clinical studies.

Fruit juice and fish oil
Omega-3 is found in vegetables and oily fish. The children included in the study will be drinking a specially made fruit juice with fish oil from Norway. The dose of it will be increased over time – as the researchers want to see how the dosage affects the body and if a higher dosage better reduce the risk of late complications and relapse, or maybe just give unnecessary additional risk side effects. The importance of children’s normal diet and previouse fatty acid balance will be investigated thouroughly.

– We want to see what balance is prefered. To see this, we examine the children carefully and measure the cells’ membranes and blood fats repeatedly. The first thing we want answered is how big dose the child needs to feel better, and if any side effects occur. In a few years when Phase 2 is completed, hopefully we know if the risk of relapse can be avoided for children receiving the supplementation, says Per Kogner.
Omega-3 combined with traditional treatment

The research team examines particularly the balance between omega-3 and omega-6,

– Both fats are important for the body’s cell membranes and other processes in the body that inflammation and the immune system, including programmed cell death. Unfortunately, the modern diet has too much omega-6 compared to omega-3.

Another very important part of the research team’s study is to evaluate whether omega-3 fatty acids can be combined with chemotherapy and / or radiation early in cancer treatment.

– The combination may result in us being able to cure more children, while improving nutrition and immune defense. In a few years, the results of our studies might be of value for children with cancer, even for those with leukemia and other tumors, not only neuroblastoma and medulloblastoma.

Kind and effective supplements in cancer treatment
If a supplement of omega-3 fatty acids work in the treatment of children with cancer, says Per Kogner that it will be something completely new.

– We know that chemotherapy kills both cancer cells and normal cells as a double-edged sword, which can both cure cancer and cause severe complications. Omega-3 fatty acid kills cancer cells but protects normal cells, especially brain cells are sensitive. In this way, these fatty acids are both sword and shield at once. With omega-3 sword, you can kill the cancer cells while its shield protects the body’s other cells. It will be both a protective and effective supplement in cancer treatment, the combined sword and shield, says Per Kogner.

Facts about polyunsaturated fats
• Polyunsaturated fats are essential for life. The body can not produce them, we have to get ourselves in them through food.
• The most important polyunsaturated fats are omega-3 and omega-6.
• Omega-3 found in oily fish such as salmon, mackerel, herring and sardines, some seaweed, walnuts, canola oil and flaxseed.
• Omega-6 For example, in corn oil, sunflower oil and rapeseed oil.
• Omega-3 and Omega-6 has many different functions and is required in particular for the body to build and repair cells. They also affect the regulation of blood pressure, the kidneys are functioning and our immune system.
• Omega-3 and omega-6 affects the body in different ways. In many cases omega-3 attenuates the effects of omega-6, for example, when it comes to blood clotting and the immune system. Both lipids interact and it is therefore important to get through the food right amount of both.

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.’

 

16 MNOK to BerGenBio from the Wellcome Trust

Oslo Cancer Cluster member BerGenBio AS has been granted a 1.6 million (NOK 16 million) Seeding Drug Discovery Award from the UK’s Wellcome Trust to develop novel small molecule inhibitors against BGB002, its proprietary, novel cancer target.

The Wellcome Trust Seeding Drug Discovery Awards are to identify and fund especially promising, innovative new therapeutic concepts through to clinical implementation and applications are highly competitive.

 


We strongly encourage other members of the Oslo Cancer Cluster to apply for funding from the Wellcome Trust as well:


 

Novel cancer target
BGB002 is a novel cancer target identified by BerGenBio, which controls tumour cell malignant features. This gene is up-regulated in several cancer types incluApplication Not for Profit – the Wellcome Trustding the difficult to treat malignancies such as triple-negative-breast cancer. Using its CellSelect? technology, BerGenBio demonstrated that BGB002 strongly activates tumour cell Epithelial-Mesenchymal Transition (EMT), a precursor to metastatic spread. Subsequent target validation studies demonstrated BGB002’s unique and pivotal role in mediating EMT, facilitating the escape of transformed cells and engendering resistance to standard of care anti-cancer regimens..

BerGenBio holds patent applications on BGB002 and is developing novel selective small molecule inhibitors to the target with Sygnature Discovery Ltd, the UK’s largest independent service provider of integrated drug discovery, with expertise in medicinal chemistry, in vitro bioscience, computational chemistry and informatics.

The Award, which is made in the form of a convertible loan, will fund the next phase of the Company’s BGB002 development project over the next 12 months.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
“The receipt of this Wellcome Trust Seeding Drug Discovery Award is a tremendous achievement and a solid endorsement both for BerGenBio’s expertise in identifying key molecular drivers of aggressive drug resistant cancers and for our ability to translate these discoveries into viable drug candidates. I am particularly proud of the successful collaborative effort by our staff and the team at Sygnature. They work exceptionally well together and provide complementary skill sets. Scientists from BerGenBio and Sygnature worked co-operatively across their respective sites to assemble a highly compelling application and successfully co-presented the project at the final evaluation stage.

“The Wellcome Trust receives hundreds of applications for this type of funding and grants just a few awards each year to projects with outstanding science and innovation that are working to address a substantial unmet medical need.

“This funding will aid in our research and development effort to uncover novel small molecule therapeutics to treat aggressive, resistant cancers.”

 

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

 

About the Wellcome Trust
The Wellcome Trust is the second-highest-spending global charitable foundation, dedicated to achieving extraordinary improvements in human and animal health. It supports bright minds in biomedical research and the medical humanities, including public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk.
For more information on the Seeding Drug Discovery Award, please visit the Wellcome Trust website: http://j.mp/SeedingDrugDiscovery


About Sygnature Discovery Ltd.
Sygnature Discovery is the UK’s largest independent provider of integrated drug discovery with core capabilities including medicinal chemistry, in vitro bioscience, computational chemistry and informatics. We also provide ADME, in vitro toxicology, early safety pharmacology, in vivo efficacy models, ion channel expertise, protein production and X-ray crystallography according to our clients’ specific needs, via long-term strategic alliance partners. http://www.sygnaturediscovery.com

 

Update from PCI Biotech`s study on head & neck cancer

Oslo Cancer Cluster member PCI Biotech reported Friday August 24 that the treatment evaluation of the second group in the intra-tumour light dose escalation part of the ENHANCE study has been completed.

ENHANCE is a phase II study of Amphinex® in combination with the cytotoxic agent bleomycin in recurrent head and neck cancer patients. No serious safety concerns were raised and strong clinical effects with clear indications of tumour response were seen at this light dose level.

Three more patients
A Dose Review Committee (DRC) of clinical experts and company representatives has been established to evaluate the results and provide recommendation for the continuation of the study. The DRC has recommended that three further patients are included at the same light dose level, before final selection of the light dose for proof of concept with intra-tumour treatment. Patients for the next group are currently being screened and will be treated with Amphinex® as soon as possible.

www.pcibiotech.no

Great Kick-off for the Oslo Cancer Cluster Innovation Park

Oslo Cancer Cluster, in collaboration with Radiumhospitalets Legater, invite members and collaborators to the annual Oslo Cancer Cluster R&D Summer Meeting on Wednesday August 20th at the Auditorium , Institute of Cancer Research.

Download program and register here

The summer meeting will kick off the Oslo Cancer Cluster Innovation Park, and for the first time it will be possible to go inside the Innovation Park. As usual, we also present the new members of the cluster; Teva Scandinavia,
Smartfish, Pharmalink,  NorChip, Oncoimmunity  and SFF – Centre for Cancer Biomarkers, University of Bergen.

Program

–15:00: Registration & coffee

15:00– 15:20: “Welcome – update on main projects”
– Ketil Widerberg, General Manager of Oslo Cancer Cluster

15:20–15:40: “The Radium Hospital Innovation Campus”
– Jan Vincent Johannessen, CEO Radium Hospital Foundation

15:40–16:00: “Ullern High School – Spring 2015”
– Esther Eriksen, Ullern High School

16:00–16:20: “Oslo Cancer Cluster Innovation Park”
– Jónas Einarsson, CEO of The Radium Hospital Research Foundation, founder of the Innovation Park

16:40–17:00: Refreshments

17:00–18:00: “New Kids on the Block” – presentations from new members;
• Teva Scandinavia, Asker
• Smartfish, Oslo
• Pharmalink, Stockholm
• NorChip, Hurum
• Oncoimmunity, Oslo
• SFF – Centre for Cancer Biomarkers, Bergen

18:00: Summer networking with exclusive group tours “inside” the Oslo Cancer Cluster Innovation Park guided by Skanska

 

 

Vaccibody successfully completes a 35 million NOK financing

Vaccibody

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

“HelseOmsorg21 represent a unique opportunity”

ho21

The HelseOmsorg21 strategy process was launched in 2013 by the Ministry of Health and Care services. The aim of the national process was to promote evidence-based health and care services characterized by high quality, patient safety and efficiency.

 

The final report was presented to Prime Minister Erna Solberg and Health Minister Bent Høie June 25th by leader of the HelseOmsorg21 process John-Arne Røttingen. The strategy has five main priorities aimed at providing better public health, more groundbreaking research, and the growth of a national health industry.

 

Oslo Cancer Cluster has been heard
Oslo Cancer Cluster has contributed to the HelseOmsorg21 process with formal input to the sub-reports on the knowledge system and on health industry development.

“Oslo Cancer Cluster aims to create one of Europe’s leading centers for research, education and development of cancer, and HelseOmsorg21 represent a unique opportunity”, says General Manager of Oslo Cancer Cluster, Ketil Widerberg. “Now we have a national strategy in the health field that addresses the research- and innovation system in health, and this strategy will allow a stronger collaboration between all stakeholders”.

 

The five main priorities are

1. A knowledge boost for municipalities by a solid financing, the establishment of a national registry of municipal health services and a higher education sector and new institutes aimed at municipal needs.

2. Making Health and Care Services an area for industry growth, providing sector-specific measures and stimulate to greater interaction between the public and private sectors.

3. Easier access to and increased utilization of health data.

4. A knowledge-based health care system with greater user interaction and an emphasis on skills, and to develop, try out and document the effects of different interactions.

5. Stronger focus on the internationalization of research and increased participation in the competition in EU research systems.

 

Read more
Download Oslo Cancer Cluster`s formal input

ECCP Oncology Track Program

Stocholm

The program for the ECCP Oncology Track Sessions at NLS Days/ECCP in Stockolm is now ready. We are proud to present a strong program with international renowned speakers, representing the entire oncology value chain. The program addresses both the most important topics in oncology at the moment, plus the companies that might become the success stories of tomorrow.

Download the program for the ECCP Oncology Track Sessions here.

Immuno-Oncology and Big-Data
The ECCP Oncology Track Sessions of 2014 focus on cancer immunotherapies, the hottest topic within oncology at the moment, early-stage oncology innovations and the utilization of biomarkers, biobanks and big data for developing better cancer treatments. We are proud to present several leading speakers from academics, biotechs, as well as a strong lineup of speakers from international Pharma companies.

The program has been developed in collaboration between several leading European Oncology Milieus such as the Oslo Cancer Cluster, Cancer Bio-Santé, Cancer Campus, BioWin, Medicon Valley Alliance/Invest in Skåne and Health Capital Berlin Brandenburg.

Norwegian stand
Kindly sponsored by Innovation Norway there will be a joint Norwegian stand at ECCP/NLS Days 2014 promoting Oslo Cancer Cluster and Nansen Neuroscience Network. We invite all members to display their marketing material here.

Please contact Elisabeth Kirkeng Andersen for more information on this opportunity.