News regarding Immuno-Oncology

Øyvind Arnesen, Ultimovacs. Photo: Oslo Cancer Cluster

New Funds for Ultimovacs

Investors are recognizing the huge potential of Oslo Cancer Cluster member Ultimovacs. They are currently investing an additional 125 million NOK in the cancer research company.

 

Well known investors and Ultimovacs backers Stein Erik Hagen, Anders Wilhelmsen og Bjørn Rune Gjelsten are among financiers putting fresh money into the cancer research company, according to the Norwegian newspaper Finansavisen.

Preparing for the Stock Exchange
Kjetil Fjeldanger,  the Ultimovacs chairman, believes a stock exchange listing within 12-18 months is realistic. – We will start the preparations for a stock exchange listing to prepare for further financing, says Fjeldanger.

Ultimovacs has so far gathered a lot of funds. However, a lot of funding still remains because of the sheer cost of doing cancer research.

– Current funds will fund us until the start of phase two of clinical studies, explains General Manager of Ultimovacs, Øyvind Arnesen.

Fighting Cancer with the Body’s Own Tools
The company is developing a cancer vaccine that helps the body’s own immune system fight cancer. Currently, three concluded studies have been combined into one, and all participating patients will now be followed closely during a five year period to monitor their survival rate.

– The patients are doing well, but the documentation is not sufficient, but we continue in very good spirits, explains Arnesen.

However, a commercial vaccine will not be for sale until 2021, according to Arnesen.

Arnesen and Ultimovacs are also initiating a new study on melanoma cancer where the vaccine is used in combination with the most common immunotherapy remedies. The hope is that the two methods will strengthen each other and make an efficient cancer fighting remedy together. The study will conclude in 18 months.

Illustration photo: Shutterstock

Targovax Releases Positive Clinical Results

Targovax has received very positive results regarding the survival rate of patients with pancreatic cancer.

Immune-oncology aims to help the body’s own immune system fight cancer and the ambition is to address the unmet need for long-term survival for patients with advanced cancers.

13 of 13
The company specializes in immune-oncology and is a member of Oslo Cancer Cluster. It recently released information revealing that 13 of 13 test subjects where alive after one year of treatment in a stage two clinical trial study. In addition, an active immune response–meaning the immune system was triggered to attack the cancer–was observed in as much as 11 of 13 patients.

No allergic reactions
These results came after the number of test subjects were reduced from 19 to 13 to see if allergic reactions stalled with reduced dosages of the TG01; Targovax’s lead RAS immunotherapy product. And luckily, no serious allergic reactions were observed,

Magnus  Jäderberg MD, Chief Medical Officer of Targovax, said:

– We are delighted that we maintain a strong immune response and one-year survival rate with the reduced dosing  regimen, essentially  equivalent  to  and  consistent with the previously  reported data  from the  main cohort.

These new results are so positive that stock market analysts DnB Markeds predict a serious stock market rise for Targovax.

 

About Targovax

Arming the patient’s immune system to fight cancer

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

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

Read more

 

Missed Us at Oslo Innovation Week?

Luckily, all our events at Oslo Innovation Week and Forskningsdagene are available for a rerun. Have a look!

We had great audiences during our three events on the 27th and 28th of September. If your were not among them, sitting in the brand new science centre of the Norwegian Cancer Society, do not despair. The events were all live streamed on Facebook. You still have a chance to experience them right here.

The events were co-hosted with our partners the Norwegian Cancer Society, the Norwegian Radium Hospital Research Foundation (Radforsk), IBM, Cancer Research UK, Norway Health Tech and EAT.

 

The first event of the week was titled “Antibiotic resistance and cancer – current status, and how to prevent a potential apocalyptic scenario”.

Antibiotic resistance and cancer – Current status, and how to prevent a potential apocalyptic scenario #OIW2017

Posted by Kreftforeningen on Tuesday, September 26, 2017

 

Our secondary event had the title “Cancer research and innovation – benefit for patients”.

Cancer research and innovation – benefit for patients #OIW2017

Posted by Kreftforeningen on Wednesday, September 27, 2017

 

The third and final event on our Oslo Innovation Week calendar was about how big data may transform the development of cancer treatments. 

How Big Data may transform the development of cancer treatments #OIW2017

Posted by Kreftforeningen on Wednesday, September 27, 2017

Collaborating in new research project, from the left: Professor Ola Myklebost, leader for NCGC and the research project, Dr. Richard Stratford, CEO of OncoImmunity, Professor Eivind Hovig, Institute for Cancer Research at Oslo University Hospital and Dr. Trevor Clancy, CSO at OncoImmunity.

Immunotherapy: Finding the Right Fit

A new Norwegian research collaboration helps uncover what treatments are the right fit for American cancer patients. Who are the collaborators and what are they doing?

There’s a lot of excitement and optimism concerning immuno-oncology, where the method is to utilize a person’s own immune system to treat cancer. However, excitement aside, methods such as this are often a costly experience, in expenses as well as negative and unpredictable side-effects for the person in treatment.

Calibrated Collaboration
Company OncoImmunity is collaborating with the Norwegian Cancer Genomics Consortium (NCGC) in finding out what is causing these serious and unpredictable side-effects.

– This collaboration is an exciting opportunity for us. This is because we can demonstrate the strength of our advanced bioinformatics tools and show how they can be used to detect combinations of genetic variation in the patient, as well as neoantigens in the tumour that can further be used as biomarkers for sensitivity to this type of cancer treatment, says Dr. Richard Stratford, CEO of OncoImmunity, in a recent press release.

OncoImmunity develops proprietary machine-learning software for personalized cancer immunotherapy. The company previously won a prestigious European grant for their work.

You can read about it here!

Patients with sarcomas
The researchers in the collaboration analyse the patient’s genes in the tumour. More specifically, they are looking at American patients by using pembrolizumab, a humanized antibody that blocks cancer protection, on patients with sarcoma – cancer in various binding tissues.

Sarcomas are a rare form of cancer where treatment for such procedures have not developed as much as other cancer treatments. Patients who have sarcoma have generally a worse prognosis than other groups.

The research will be shared with the organization Sarcoma Alliance for Research through Collaboration (SARC), helping researchers within the organization to better utilize the results.

The NCGC perspective
The NCGC has, with help from the Norwegian Research Council, established a platform for advanced analysis for such cases. On top of this, they have a vast network of expertise within the area of molecular oncology.

– We find it exciting to see better treatments that can work for multiple cancers where treatment provides promising results, despite limited response, says Professor Ola Myklebost, leader for NCGC and the research project, in a recent press release.

– It is important to be able to choose the right patients for the right treatments. Not only because the treatment is high in cost, but also because of the serious and negative side-effects, he adds.

An example of how the cytoscopy procedure is done. Photo: Photocure

Photocure’s Promising Combo

Photocure reveals promising results in bladder cancer through the use of Blue Light Cytoscopy alongside the drug Hexvix. 

Bladder cancer endangers 167,000 people in Europe annually followed by over 59,000 deaths.

Men are especially at risk, where a staggering 75% of bladder cancer cases occur. Not only that, but bladder cancer has a reputation as being one of the most expensive cancers to have, due to its high reccurence rate with an average of 61% reccurence the first year followed by 78% for the next five years.

The results we needed
As such, there is an increasingly urgent need to develop better methods of both managing and diagnosing the disease. We’re already hearing positive news from the Norwegian company Photocure; a leader in photodynamic technology. Photocure revealed the results from their study on the 18th of August, where the results appear promising in terms of prognosis and diagnosis.

The promising new combo
By combining Blue Light Cystoscopy (BLC) and Hexvix, Blue Light Cytoscopy being the insertion of a tube in the urinary tract instilled with a photosensitizing agent, they found the overall reccurence rate of three years had decreased substantially. More specifically, by combining Blue Light Cytoscopy with Hexvix, they found that the recurrence rate dropped down to 39% for the next three years, as opposed to using an optimized White Light Cytoscopy (WLC), a standard cytoscopy, that resulted in a 53.3% of reccurence.

Substantially better
The benefit was even more substantial for those with high-risk disease, where the chances of recurrence at year three were 52.1% for the Blue Light Cytoscopy combo as opposed to the White Light Cytoscopy, found to be at around 80%.

How does it work?
The probable reasoning for this improvement lies in how the new combo works to detect bladder cancer. By using Blue Light Cytoscopy with Hexvix, which is a drug that is selectively taken up by cancer cells in the bladder, they are able to see the cancer light up in bright pink. This enables the doctors  to accurately resect and make better management deciscions, thusly improving the patients outlook and way of life.

Image of metastasis in the mammory gland in relation to breast cancer.

Roche Medicine Ready to Fight Breast Cancer

On the 15th of August, drug Kadycla (trastuzumab emtansin) is finally approved by the Beslutningsforum and ready to help hundreds with breast cancer in Norway.

The drug, developed by company Roche, specifically targets patients with the variant HER2 positive breast cancer – a breast cancer that tests positive for human epidermal growth factor receptor 2, a protein which promotes growth of cancer cells.

About 15-20% of cases in breast cancer, cancer cells have a gene mutation that produces excess HER2 protein, thusly making it a more aggressive form of breast cancer as well as being resistant to hormone therapy. However, treatments that specifically target HER2 are very effective.

New Drug Kadycla
This is where newly developed drug Kadycla comes in.

Kadycla is the first medicine targeted towards breast cancer patients where the cell lymph nodes are linked to the targeted antibody; meaning it’s the first drug where lymph nodes, or parts of the cell that filter out cancer, are linked to the antibody that attacks or even neutralizes the infected cell. This causes the chemo to target the HER2 positive cancer cells.

Prolonged Survival Rate
With the drugs approval, around one hundred Norwegian cancer patients are provided with a treatment program that shows a median prolonged survival rate of 5,8 months, compared to the combination of lapatinib and kapecitabine for persons with the variant HER2-positive breast cancer.

Better Quality of Life
On top of this, it’s known that spreading breast cancer is a deadly disease with lower quality of life, but Kadycla helps by attacking cancer cells in place of the body’s own healthy cells. Essentially, this means better quality of life for the patient due to fewer symptoms brought on by the disease.

Reached an Agreeable Solution
Kadycla, since September in 2014, has been recommended in the Norwegian Breast Cancer Group’s medical guidelines for those who would benefit from its capabilities. Roche, in this case, through the span of three years aligned eight different pricing options for the authorities. In regards to this, Audun Ohna, director of market access and pricing, comments:

– We have worked a long time so that Norwegian breast cancer patients can have the chance to use Kadycla in Norwegian health services. After roughly three years negotiating, where we have stretched ourselves thin both economically and in variating payment solutions, we can finally and gladly say we have reached a solution that is both acceptable for both parties. This will benefit patients, doctors and society as a whole.

New member Precision Oncology at the summer party. From the left: Patricia Devitt, President, Maureen Higgins, Director of Clinical Operations, Deborah Phippard, Vice-president and Andrea Cotton-Berry, Head of Strategic Operations.

Meet our new members – Part One

We are proud to introduce Oslo Cancer Cluster’s new members. This is the first part of two stories about our new members.

You can find the second part HERE.

On the 24th of August, Oslo Cancer Cluster hosted a summer party with the intention of getting to know their newest members in an informative and fun setting. The party started with a heartfelt welcome and speech held by Oslo Cancer Cluster’s General Manager Ketil Widerberg and intensive mingling amongst guests. After the welcome was in order, each member stood up, in turn, to introduce their amazing work.

Of the 14 new members we have so far this year, here’s an introduction to those who primarily work in the area of biotechnology.

Precision Oncology
Precision Oncology is a specialty contract research organization (CRO) that provides clinical research services. The company primarily provides application of metrics-driven project management to perfect oncology drug development.

As for their inspiration and reasoning for joining the Oslo Cancer Cluster roster of members, Andrea Cotton-Berry, head of Strategic operations at Precision Oncology, responds:

– What really inspires us at Precision Oncology, is matching the right drug to the right patient, by using biomarkers for patient identification and stratification; a true personalized medicine approach, to find more efficient treatments for patients with advanced cancers. We are looking forward to bringing our team of oncology development experts to contribute to the Oslo Cancer Cluster mission and initiatives, especially advancing immuno-oncology research.

Personalis
Personalis is a leading preciscion medicine company focused on advancing next generation sequencing based services for immuno-oncology. The company is mainly focused on producing the most accurate genetic sequence from each sample set, and using analytics and privately owned content to draw reliable and accurate biomedical interpretations of the data.

In regards to current and future inspiration, Erin Newburn, Senior Manager and Field Applications Scientist at Personalis, comments:

– We aspire to utilize next-generation sequencing as a multi-dimensional platform for bio-marker discovery across cancer therapeutics, as well as throughout developmental stages.

iNANOD
iNANOD is a nanotechnology based anti-cancer drug developing company established in 2016. Their goal is to increase efficacy of anti-cancer drugs and to reduce side-effects for cancer patients as well as maximizing the patients longevity. They aim to become a pharmaceutical company for anti-cancer nanomedicines in the near future.

As for expectations and reasoning for joining Oslo Cancer Cluster, Nalinava Sengupta, CEO and Co-Founder of iNANOD shares his view:

– We think our project – to develop cancer nano-medicine – fits best with Oslo Cancer Cluster. In the incubator we get in touch with other similar firms who have achieved milestones in cancer drug delivery. We expect synergistic knowledge transfer within the incubator network, as well as various kinds of help from the cancer research related entrepreneurial ecosystem developed at Oslo Cancer Cluster. This also helps with business developmental aspects and project application writing.

Norgenotech
Norgenotech is a start-up company that originated from the EU project COMICS that aimed at improving production methods for analysis of DNA damage and repair. Norgenotech mainly assesses genotoxicity, or property of chemical agents that damage the genetic information within a cell, as well as drugs. The company also participates in research projects and developing tools for measuring DNA integrity in patients.

Eisai
Eisai AB originates from a global company in Japan that is active in the manufacturing and marketing of pharmaceutical drugs, pharmaceutical production systems, and over-the-counter drugs. Eisai AB, that will be joining the Oslo Cancer Cluster roster of members, is the sales subsidiary of Eisai Company.

Immunitrack
Immunitrack is a startup company with capabilities in production and studies of protein molecules central to the adaptive immune system in humans in order to develop new therapeutics. Their mission is to provide the research community with tools to redesign or select drug candidates at the early stage of research and development, but also to provide reagents to monitor leading drug candidates effect on patient’s immune system.

Nacamed
Nacamed‘s goal is to produce nanoparticles of silicon material for targeted drug delivery of chemotherapy, radiation therapy and diagnostics to kill cancer cells. By using silicon nanoparticles in cases such as therapy, the particles are biodegradable which entails a clean delivery without any side-effects as they completely disappear and dissolve from the body.

Arctic Pharma
Arctic Pharma is a privately held startup biotech company founded in 2012 that primarily focuses on developing innovative anti-cancer drugs. They do this by exploiting cancer cells and their peculiar features, or more specifically, by targeting key enzymes that are upregulated, or have been increased in terms of stimulus with inhibitors designed at Arctic Pharma. Essentially, their main mission is to become a leader in designing cancer therapies that are both environmentally friendly and have few side effects.

The team from Thermo Fischer Scientific Norway accepts the Innovation Award. From the left: Director of Research Erlend Ragnhildstveit, Minister of Trade and Industry Monica Mæland, CEO Ole Dahlberg and Senior Researcher Geir Fonnum. Photo: Sindre Mekjan/Forskningsrådet

Thermo Fisher Scientific Wins Innovation Award

The Research Council of Norway has given Thermo Fisher Scientific the prestigious Innovation Award for their Dynabeads.

 

The Oslo Cancer Cluster member Thermo Fischer Scientific was awarded the prize for developing an entirely new variant of an existing product, making it possible to analyse human genes quickly and effectively and improve diagnostic testing and patient treatment.

This is the technology known as «Dynabeads» that makes faster and cheaper DNA-sequencing accesible.

– The award means a lot to us as a company, and to everybody who has been working on product, production and launch during these years. It is an acknowledgement that investment, cooperation and important global products are noticed, says Ole Dahlberg, CEO at Thermo Fischer Scientific Norway.

Vital role in Norwegian biotech
Thermo Fisher Scientific is one of Norway´s leading biotechs and among the most profitable. The company has played a vital role in Norwegian biotech with the development of «Dynabeads», used all over the world to separate, isolate and manipulate biological materials.

Thermo Fisher’s Dynabeads are used in basic research, in billions of diagnostic tests, as well as in immunotherapy.

In May this year, Thermo Fisher Scientific was nominated for the “Norway’s smartest industrial company” award for the same technology. The smart element was using the beads in a completely new way on a microchip in combination with semiconductor technology. This link between biotech and electronics has created the instruments from Thermo Fisher which we now see in research institutes and diagnostic labs all over the world.

Ambitious research and development
– Thermo Fisher Scientific is carrying out an ambitious research and development effort in a very important area. The company is achieving this by using its own resources, seeking cooperation with exacting customers and drawing on public funding schemes from, among others, the Research Council of Norway. In this way, the company contributes to job creation as well as value creation, said Monica Mæland, Minister of Trade and Industry, according to The Research Council of Norway. She presented the Innovation Award during the Arendal Week in August.

The Research Council’s Innovation Award comprises a cash prize of NOK 500 000 and is given each year to a business or public entity that has demonstrated an outstanding ability to apply research results to create research-based innovation.

Else Marit Inderberg and Sébastien Wälchli often work in one of the cell labs in Oslo Cancer Cluster Incubator. Photo: Christopher Olssøn

How Cancer Research Becomes a Company

The Department of Cellular Therapy is great at transforming cancer research into new companies. The latest spin-out is Zelluna.

 

The Department of Cellular Therapy at the Radium Hospital, Oslo University Hospital, features one of Europe’s largest and most modern good manufacturing practice (GMP) facilities for cellular products. Head of the department is Prof. Gunnar Kvalheim. They are also conducting translational research, and their research has been spun out as several companies, such as the newly established company Zelluna.

The immunomonitoring unit is a major part of the department, and is led by Else Marit Inderberg. This unit is situated in the Oslo Cancer Cluster Incubator, which is an integrated part of the Oslo Cancer Cluster Innovation Park. A translational research lab has been created and is associated to the immunomonitoring unit.

The cancer killer
“Our major strength is that we have all aspects within the department to take cellular research from the bed to bench and back again. We have the equipment and the specialists to do everything here”, says Inderberg.

Together with Sébastien Wälchli, she is also the project leader for the translational research lab. Here, they develop cancer vaccines and work with adoptive T cell therapy. A T cell, or T lymphocyte, is a type of lymphocyte (a subtype of white blood cell) that plays a central role in cell-mediated immunity. T cells have the capacity to kill cancer cells.

In the lab, they look for a T cell receptor (TCR), which is a molecule found on the surface of T cells. They use Chimeric antigen receptors (CARs), which are engineered receptors that graft an arbitrary speci city onto a T cell. Ultimately, the researchers work with a universal cell line for cellular therapy – a universal cancer killer.

This is a T cell, or more precisely, an actin cytoskeleton of a T lymphocyte. The picture is obtained by a special micro- scope. The cell’s size: 38*38 μm. Photo: Pierre Dillard

Innovation from the biobank
“In the translational research lab, we think innovation all the time. In our research, we actively search for solutions to unmet medical needs within cancer”, says Inderberg.

The translational research lab was built upon the work done by the section for immunotherapy established by professor emeritus Gustav Gaudernack, and most of its activity relies on the use of a database of patient samples called the biobank. This specific biobank represents an inestimable source of information about the patients’ response to immunological treatments over the years. Furthermore, the patient material can be reanalysed and therapeutic molecules isolated. This is the basis of the company Zelluna.

Industrial collaborations
The Department of Cellular Therapy is heavily involved in both academic and industrial collaborations. The latter include collaborations with several biotech companies as well as pharma companies situated in the Oslo Cancer Cluster Innovation Park, developing novel immunotherapy cancer treatments. Examples of industrial collaborations are the German company Medigene, the Norwegian biotechs Targovax, Ultimovacs, Lytix and PCI Biotech, and the bigger biopharmaceutical companies BMS, Novartis and ThermoFisher.

In addition to their industrial collaborations, the Department of Cellular Therapy also wants to commercialise their own projects.

The Zelluna Spin-out
“Our latest spin-out is Zelluna, which has recently been set up as a start-up. Staff has just been hired to drive the development of TCR-based therapies to clinical trials”, says Sébastien Wälchli.

The TCR-approach is based on identication of T cell receptors from patients clinically benefitting from treatment with vaccines from back in the nineties and early 2000s. The approach is to modify the patient T cells to express the same receptors before giving the cells back to the patients, ready to combat the cancer cells.

The company has been established through the efforts of the Radium Hospital Research Foundation as well as Inven2.

“This is a very interesting and unique approach. We are eagerly anticipating the development of the company”, says Inderberg.

Ole Johan Borge, director at the Norwegian Biotechnology Advisory Board, at the breakfast meeting "Your genes – the key to the future of cancer treatment?", 6 June 2017.

How Our Genes Will Change Cancer

Doctors, researchers and audience gather at breakfast to learn about genetics, data and how working together will help beat cancer.

The time is 8:15. Many have started to file in and shuffle to their seats while chatting and occasionally sipping their first morning coffee. As it starts to quiet down, the lights are dimmed, the audience wake up and the breakfast meeting begins.

An air of seriousness with a hint of respect changes the atmosphere, and the audience watches as the first guest speaker steps in and introduces the concept of genes and their relation to cancer.

– Cancer is brought on by errors in our genes. Most of the time, cancer is a result of the unlucky, says Borge, who is the director at the Norwegian Biotechnology Advisory Board.

This is the start of his talk on genes and cancer, where the audience is introduced to that which defines us most: DNA, the molecule of life.

To the moon and back
– 20,310 recipes in our genetic material. 2 meters of DNA in every cell. 10 Billion cells, of which 20 billion meters of DNA is found. If you do the math, astonishingly it amounts to 26,015 trips back and forth to the moon, Borg says, as he shows us a visual representation on the powerpoint slide. (See video in Norwegian.)

It’s this incredibly long strand of genetic material where things can go horribly wrong. If there’s a genetic error, or mutation in the DNA that happens to take place between the double helix and if there’s enough errors, cancer happens. This is the unfortunate fate for many of us.

– However, we may not have come a long way in finding the ultimate cure for cancer, but what we have accomplished is the ability and possibility of analysing, and ultimately predicting, cancer through genome sequencing, Borge says.

It was the best of times…
This message, as a central theme to the breakfast meeting taking place, shines a hopeful light in an otherwise frightful and serious subject. With genome sequencing, or list of our genes, scientists and doctors will have greater accuracy to predict genes that are potential carriers, and highly susceptible to, different cancers.

However, this requires a large amount of genome sequences: we need an army of genome data.

From terminal to chronic
To set further example, the next speaker to take the stage is oncologist Odd Terje Brustugun. He stresses the importance of personalized treatment for lung cancer patients, even those with metastatic cancers. These patients can be tested today to see if they are viable to receive new kinds of treatmemt, such as targeted therapy. This was the case for lung-cancer patient, and survivor for five years, Kari Grønås.

Kari Grønås was able to participate in a clinical study. She was treated with targeted therapy instead of the ordinary treatment for lung cancer patients at that time: chemotherapy.

– I feel I have gone from feeling like I have a terminal disease to a chronic one, she says from the podium.

Beating cancer: the story of us
This personalized approach is arguably what worked for Kari, setting the example and potential for the future. If we can analyse our own genes for potential cancer, then we are both able to prevent and provide personalized medicine catered to the individual. This is why genome sequencing is important for the future.

However, this cannot be done alone. To get a representable treatment for the individual, we need data. And data does not come reliably from one individual, but from the many.

– It is not your genes that are the key for tomorrows cancer research, it is ours. It is collaboration where large amounts of data and correlation will give us the knowledge that ensures the right path towards the future. A future with better cancer treatment for all, says Ole Johan Borge.

Vaccibody moves forward with HPV-study

Oslo Cancer Cluster member Vaccibody is moving forward with the first vaccination of a patient with the human papillomavirus, HPV-virus, in a phase IIa study using the company´s immunotherapy platform. 

The primary objectives of the phase IIa study are to assess T cell mediated immune responses in the peripheral blood and to evaluate early signs of efficacy.

-We have been encouraged to see the outcome of the phase I trial and are excited to initiate this phase IIa clinical study. This offers a chance to get information on how patients respond to the Vaccibody immunotherapy platform, says Principal investigator, Prof. Dr. med. Karl Ulrich Petry, Department of Obstetrics & Gynaecology Klinikum Wolfsburg.

Moreover, the treatment can potentially also cure the underlying HPV infection, Petry comments, and thereby prevent recurrence and may protect from other HPV induced cancers.

 

Will outlicence the vaccine after phase II

– We are pleased to announce the vaccination of the first patient. Surgery is currently the only available therapy to remove abnormal cervical lesions caused by HPV-virus, and thereby stop the progression to cervical cancer, says Martin Bonde, CEO Vaccibody.

Bonde says that the plan is to have enough patients recruited by the end of Q3 and hence the first read out of the data in Q1, 2018.

-As of now we see that we will need a phase IIb/III study involving more patients, maybe up to 150-200. As of now we plan to out licence this product if we see the right responses, says Bonde.

 

About Vaccibody AS

Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. Vaccibody also has a strong focus on so-called cancer neoantigen vaccines and is in late preclinical development with this program.

www.vaccibody.com

 

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.

 

 

 

Targovax ASA moves share listing to Oslo Børs

Targovax ASA’s shares have been accepted to list on Oslo Børs, the main Oslo Stock Exchange. 

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

Øystein Soug, Chief Executive Officer of Targovax, said in their press release this week:

“This move marks another exciting step for Targovax. Being part of the main market is an important development for the future of the company, giving us access to a larger investor base and helping enhance our visibility. We are pleased to have had the support from the Axess market and are delighted to have been accepted on to the Oslo main market.”

Several milestones
The company has achieved several milestones since it listed its shares on Oslo Axess in July last year:

  • Encouraging top line two-year survival data from the TG01 clinical trial in resected pancreatic cancer patients. Data showed a survival rate of 68 % from the first patient cohort compared to published historical rate of 30-53 %. This suggests a signal of clinical efficacy for the drug candidate.
  • Granting of European patent for ONCOS-102, protecting Targovax’s ONCOS platform lead product until 2029.
  • Strengthening the team with the appointment of Øystein Soug as Chief Executive Officer and the appointment of Erik Digman Wiklund as Chief Financial Officer.
  • Presenting at a number of scientific and investor conferences.

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

 

 

 

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.

 

Podcast on cancer research and development

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

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

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

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

Here you may find all podcast episodes launched so far.

Record high attendance at Cancer Crosslinks – watch and dowload presentations

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

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

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

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

 

Download the presentations

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

You may watch most of the presentations here:

You can download presentations from the meeting here:

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

 

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

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

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

 

The best treatment for each patient

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

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

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

 

10 years anniversary next year

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

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

The Economist & Oslo Cancer Cluster: War on Cancer Nordics

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

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

 

Questions we will answer

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

 

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

7 Oslo Cancer Cluster members granted funding from the Research Council

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

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

Overview of member companies and their funded projects:

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

Targovax with full year report

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

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

Presentation

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

 

 

 

About Targovax

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

 

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

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

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

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

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

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

 

 

Lytix Biopharma granted 15.9 MNOK from The Research Council of Norway

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

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

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

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

Lytix Biopharma granted 15.9 MNOK from The Norwegian Research Council

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

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

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

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

www.lytixbiopharma.com

PCI Biotech granted NOK 13.8 million from the Research Council

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

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

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

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

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

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

www.pcibiotech.no

Cancer Crosslinks 2017 will be streamed

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

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

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

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

Cancer Crosslinks 2017

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The main characteristics of ONCOS-102 include:

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

 

 

About Targovax

Arming the patient’s immune system to fight cancer

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

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

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

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

Poster details

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

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

 

Nordic Nanovector and Heidelberg Pharma with new collaboration

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

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

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

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

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

 

New BGB324 study points to novel mechanism to enhance immunotherapy efficacy

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

 

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

 

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

 

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

 

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

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

 

 

About BGB324

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

About BerGenBio AS

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

For more information see here.

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

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

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

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

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

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

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

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

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

Oslo, Norway, 5 September 2016

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

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

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

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

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

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

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

PCI Biotech and BioNTech initiates preclinical research collaboration

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

 

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

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

 

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

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

 

Ultimovacs satser sterkt på videre utprøving av lovende kreftvaksine

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

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

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

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

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

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

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

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

__________________________________________________________________________________

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

Nordic Nanovector completes recruitment of the first cohorts

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

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 

 

Nordic Nanovector and AREVA Med to investigate potential of lead-212 conjugated anti-CD37 antibody for treating leukaemias

Nordic Nanovector, a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology, and AREVA Med, the AREVA medical subsidiary developing lead-212 (212Pb) based cancer therapies, announced today that they have entered into a collaboration agreement to investigate the potential of a 212Pb-conjugated anti-CD37 antibody for the treatment of leukaemias. Leukemias are orphan diseases with a significant unmet medical need. Prevalent relapsed AML and CLL patients are more than 60,000 per year worldwide. This represents a growing market worth over USD 5 billion by 2020.

Under the terms of the agreement, Nordic Nanovector will provide its chimeric anti-CD37 antibody (NNV003) and its expertise in antibody radionuclide conjugate (ARC) development while AREVA Med will provide expertise in the production of 212Pb, in the development of Targeted Alpha Therapies using this radionuclide and in site-specific bioconjugation methods through its Macrocyclics subsidiary.

The radionuclide 212Pb has important characteristics that make it an attractive payload for the treatment of leukaemias where there is no substantial tumour mass and tumour cells are in close proximity to healthy tissues. These properties are based on the decay chain of 212Pb with the emission of very short range alpha particles, thereby offering the potential to create innovative therapies with highly localized targeting and tumour cell killing with improved tolerability.

Preclinical studies to determine the initial safety and efficacy profile of the novel anti-CD37 212Pb-ARC will be conducted at AREVA Med’s facility in Plano, Texas, USA. Nordic Nanovector has the option to license any resulting ARCs for further development and AREVA Med has the option to license the use of CD37-targeting antibodies for its own purposes.

Both companies will contribute to the collaboration, which will also benefit from grant funding awarded in February 2016 to Nordic Nanovector from the Research Council of Norway’s user-driven research-based innovation program (in Norwegian; Brukerstyrt innovasjonsarena, BIA).

Nordic Nanovector’s Chief Scientific Officer, Jostein Dahle, commented: “The CD37 antigen is expressed on the surface of many haematological cancer cells, including leukaemia cells, making it an important target for ARC-based therapies. Our long-term strategy is focused on building a pipeline of products that leverages our expertise in CD37-targeting and ARCs, combined, where necessary, with therapeutic payloads and complementary expertise from partners such as AREVA Med. We are excited to begin this new collaboration and to evaluate the potential of this novel 212Pb-ARC for treating leukaemias.”

Patrick Bourdet, President & CEO of AREVA Med added: “In addition to our recent facility opening in Texas for the production of 212Pb and development of Targeted Alpha Therapies with 212Pb, this new partnership with Nordic Nanovector expands our project pipeline and places AREVA Med in a very strong position to meet the anticipated acceleration of our development.”

For further information, please contact:

Tone Kvåle, Chief Financial Officer

Phone: +47 91 51 95 76

E-mail: ir@nordicnanovector.com

International Media Enquiries:

Mark Swallow/David Dible (Citigate Dewe Rogerson)

Tel: +44 207 282 2948/+44 207 282 2949

Email: nordicnanovector@citigatedr.co.uk 

AREVA Med

Alison Tise

Tel: (301) 841-1673

Email: alison.tise@areva.com  

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 a 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 USD 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 Phase1/2 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 regulator submission anticipated in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation to 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

About AREVA Med

AREVA Med is the AREVA Group Medical subsidiary formed in 2009 to develop new therapies to fight cancer. AREVA Med has developed a unique process to extract lead-212 (212Pb), a rare metal used in targeted alpha therapy (TAT), a novel approach which targets and destroys cancer cells, while limiting the impact on nearby healthy cells. AREVA Med collaborates with world-renowned scientific partners, and formed a strategic global alliance with Roche in 2012, to create a new advanced alpha radioimmunotherapy platform.

For more information:  www.arevamed.com. Follow @AREVAmed on Twitter.

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

  

Targovax receives approval in Australia to conduct a clinical trial with TG02

Targovax receives approval to conduct a study with TG02 and pembrolizumab, a checkpoint inhibitor, in patients with locally recurrent RAS mutated rectal cancer.

TGO2 is a cancer vaccine containing a mixture of 8 synthetic peptides representing fragments of the most common RAS mutations seen in colorectal cancer disease.

Mutations in RAS, a protein regulating cell growth, is seen in about 50% of patients with colorectal cancer and 20-30% of all cancers. It is associated with a lack of response to chemotherapy and poor prognosis. Previous and ongoing clinical studies have shown that TG peptides are able to induce RAS mutation specific immune responses. Targovax is the only research organization with RAS mutated specific vaccines at clinical development stage. This will be the first study with TG02 in humans and 20 patients will be included at Australian sites.

The study will assess safety and immune activation, both at lesional level and in peripheral blood. One cohort will only receive TG02 and another cohort will receive TG02 in combination with pembrolizumab, a PD-1 receptor inhibitor.

“We have already shown in other indications that TG peptides can induce specific immune responses and that these are associated with clinical benefits. However, this study will take us one step further in assessing immune activation at tumor level. It will also give us an indication on how our immune therapy may be enhanced when combining with a check point inhibitor” says Magnus Jaderberg, CMO at Targovax.

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

Science publication on a breakthrough methodological development

Erlend Strønen, Johanna Olweus and the Immunotherapy Jebsen Center team’s work on a breakthrough methodological development in generating  broad and tumour-specific T-cell immune responses has been published in Science. The work is based on a novel allogeneic approach. This is a powerful technological development which can in the relatively near future be subjected to clinical testing.

Link to on line publication

 

Presentations from the Day of Immunology

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

 

 

Morning session (popularized science in Norwegian)

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

 

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

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

 

 

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

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

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

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

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

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

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

 

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

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

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

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

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

About BerGenBio AS

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

Nordic Nanovector ASA: Betalutin® continues to show promising efficacy

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

 

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

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

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

 

Key conclusions from the update include:

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

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

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

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

Targovax reports immune response with reduced number of  TG01 vaccinations

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

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

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

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

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

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

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

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

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

View videos and presentations from Immuno-Oncology Educational Series 2016

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

 

  • Video

Please follow this link for videos of the presentations.

 

  • Presentations

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

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

 

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

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

 

Presentations are published by courtesy of the lecturers.

 

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

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

 

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

Martin Bonde, CEO Vaccibody. Photo: Henriette Dan Bonde

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

 

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

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

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

 

About VB10.16

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

 

About Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer

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

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

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

 

About Vaccibody AS

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

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

www.vaccibody.com

 

 

Nordic Nanovector will present at AACR

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

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

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

 

About the AACR annual meeting

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

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

 

 

 

About Nordic Nanovector

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

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

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

Further information about the Company can be found here.

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

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

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

 

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

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

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

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

About Vaccibody AS

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

Contact:

Martin Bonde, CEO

+47 22958193

mbonde@vaccibody.com

 

 

PCI Biotech and Ultimovacs initiate preclinical research collaboration

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

 

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

 

Cancer vaccination

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

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

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

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

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

PCI Biotech: Dose escalation in the bile duct cancer study completed with promising early signs of efficacy

Oslo Cancer Cluster member PCI Biotech reports that the treatment evaluation of the fourth dose cohort in the Phase I/II study of fimaporfin (Amphinex®) in patients with inoperable bile duct cancer has been completed. The Cohort Review Committee (CRC) of clinical experts and company representatives has recommended that the study progress into Phase II, based on promising early signs of efficacy in the last cohorts.

 

The CRC has reviewed data from twelve patients that have completed the safety evaluation window and no dose limiting toxicities or other safety concerns have been reported thus far in the study. CRC’s recommendation is based on early promising signs of tumour response in the last dose cohorts (both partial and complete responses), combined with experience from earlier clinical studies with fimaporfin.

Coordinating Investigator, Dr. Richard Sturgess at Aintree, said -Bile duct cancer has a remarkable resistance to chemotherapy and these patients are lacking good alternative treatment options. The combination of fimaporfin and gemcitabine represents a new and innovative treatment concept that could potentially produce significant clinical benefit. The results of the Phase I part of the study are encouraging and I look forward to working with my fellow investigators on the continuation of this study.

The Phase II part of the study will be slightly modified to draw on the experiences gained from Phase I, as well as recommendations from the investigators and PCI Biotech’s Scientific Advisory Committee. Phase II will commence when the amended protocol has been approved by regulatory authorities and ethics committees.

Per Walday, CEO of PCI Biotech, said -This is an important milestone for PCI Biotech. We are confident that fimaporfin (Amphinex®) has potential to provide clinical benefit in bile duct cancer, which is an orphan disease with high need of new local treatment options. Fimaporfin fits well with the treatment need of this disease, both with regard to the standard endoscopic procedures and our technology’s ability to enhance the recommended cancer therapy.

 

Facts:

About bile duct cancer
Bile duct cancer originates in the bile ducts, which drain bile from the liver into the small intestine. It is a rare cancer (an orphan disease) without approved chemotherapies and the development pipeline is limited. Annual incidence rates of 1-2 cases per 100,000 are seen in the Western world, but rates have been rising worldwide over the past several decades. The majority of cases present as inoperable and there is a high unmet need for improved treatment technologies.

 

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.

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 both of existing cancer drugs and by realizing the large potential in new therapeutics, including therapeutic vaccines.

For more information see. http://www.pcibiotech.com

 

Cancer Crosslinks 2016 will be streamed

Cancer Crosslinks 2016 features a really interesting program. For those of you that may not take part of the actual conference in the Oslo Cancer Cluster Innovation Park, you may watch the whole program at your computer as we will live stream from 9:00 – 16:30.

Over 240 people from all over Norway have signed up for this years Cancer Crosslinks. The program focuses on immuno-oncology and features strong international thought leaders as presenters. Cancer Crosslinks is hosted by Oslo Cancer Cluster and sponsored by BMS and Janssen.

 

 

 

Thermo Fisher Scientific will create Google-like envionment for biotech in the Oslo Cancer Cluster Incubator

Thermo Fisher Scientific will rent over 800m2 in the Oslo Cancer Cluster Incubator. Here, the company will create a creative Google-like environment with a particular focus on diagnostics and the development of new treatments using cancer immunotherapy.

 

 Thermo Fisher Scientific is one of Norway´s leading biotechs and among the most profitable. The company is expanding and during the first quarter of 2016 the entire management team, production team and parts of the R&D milieu will move to the Oslo Cancer Cluster Incubator. Here, 800m2 will be set up like a creative Google-like office space.

– We are really pleased that Thermo Fisher Scientific chooses to move into Oslo Cancer Cluster Incubator. The company, which initially was established as Dynal in 1986, has played a vital role in Norwegian biotech with the development of «Dynabeads» that is used all over the world. Their record of accomplishment of bringing innovative products to the market is impressing. For the environment in the incubator it is crucial to have a global, experienced actor present, says Bjørn Klem, CEO Oslo Cancer Cluster Incubator.

 

Strong in immunotherapy

The overall aim of the Oslo Cancer Cluster Incubator is to contribute to the successful development of oncology biotechs so that they may reach the market with their innovative treatments against cancer. The cancer R&D milieu in Norway in general is strong within cancer immunotherapies, which is also the case with the incubator companies.

– Thermo Fisher´s «Dynabeads» is used in basic research, in billions of diagnostic tests as well as in immunotherapy all over the world. Innovation and further applications is developed in close collaboration with research environments, clinics and industrial partners. Oslo Cancer Cluster has become one of the leading innovation clusters and we would like to take an active role in further developing the cluster. We think that co-localisation with the milieu in the incubator will be a catalyst for our growth and innovation in the future, says Ole Dahlberg, CEO Thermo Fisher Scientific in Norway.

 

Facts: 

Thermo Fisher Scientific:
Thermo Fisher Scientific in Norway (former Dynal Biotech) was established in 1986. The company focuses on the diagnostics market as well as the development of innovative immunotherapeutics, especially within oncology. The client portfolio features many of the world’s largest pharma and diagnostics companies. In 2014 the company had 180 employees and a turn-over of 760 MNOK. The company have production units both in Oslo and Lillestrøm. The Norwegian company is a subsidiary to Thermo Fisher Scientific which is listed on NYSE. www.thermofisher.com


In Norwegian:

Thermo Fisher Scientific inn i Oslo Cancer Cluster Inkubator: Styrker miljøet rundt immunterapi mot kreft

Thermo Fisher Scientific skal leie over 800m2 i Oslo Cancer Cluster Incubator. Selskapet skal skape et kreativt ‘Google-aktig landskap’ innen bioteknologi med særlig fokus på diagnostikk og utvikling av nye former for behandling ved bruk av immunterapi.

Thermo Fisher Scientific er et av Norges største biotekselskap og blant de mest lønnsomme. Selskapet utvider og flytter nå hele ledergruppen og produktorganisjasjonen, samt deler av sitt forsknings- og utviklingsmiljø over til Oslo Cancer Cluster Inkubator. I 5.etasje i inkubatoren skal over 800m2 omgjøres til et kreativt landskap for ansatte i selskapet med fokus på forskning og utvikling innen diagnostikk og immunterapi mot kreft.

– Vi er utrolig glade for at Thermo Fisher Scientific velger å flytte inn i Oslo Cancer Cluster Inkubator. Selskapet, som startet som Dynal i 1986 er en viktig del av norsk bioteknologihistorie med sin utvikling av «Dynabeads»  basert på Ugelstadkulene. De har vist gjentatte ganger at de kan kommersialisere god forskning. Det vil bety mye for resten av miljøet i inkubatoren å ha med en så erfaren aktør med global tilstedeværelse, sier Bjørn Klem som er daglig leder i Oslo Cancer Cluster Incubator.

 

Viktig for et Norge i omstilling

Oslo Cancer Cluster Inkubator skal bidra til at flere selskaper lykkes med å utvikle sin behandling av ulike kreftformer. Immunterapi mot kreft er en helt ny måte å behandle kreft på der kroppens eget immunforsvar aktiveres for å bekjempe kreftcellene. Miljøet i inkubatoren er særlig sterke innen dette fagfeltet, som blir ytterligere styrket ved at immunmonitoreringsenheten ved seksjon for celleterapi ved Oslo universitetssykehus, Radiumhospitalet flytter inn med syv ansatte i tillegg til Thermo Fisher Scientific.

 

– Thermofisher sine «Dynabeads» brukes i dag innen grunnforskning, til milliarder av diagnostiske tester og nå innen immunterapi. Innovasjon og applikasjonsutvikling skjer i nært samarbeid med forskningsmiljøer, klinikker, og industrielle partnere. Oslo Cancer Cluster har demonstrert høye ambisjoner og gjennomføringsevne på å bli en av de ledende innovasjonsklyngene og vi ønsker å være en del av det. Samlokalisering og felles aktiviteter med klinikken og andre selskaper tror vi er en katalysator for vår vekst og innovasjonsgrad fremover, sier Ole Dahlberg, administrerende direktør i Thermo Fisher Scientific i Norge.

 

– Statsminister Erna Solberg sa da hun åpnet Oslo Cancer Cluster Innovasjonspark og inkubator i august i år at helseindustri er en industri med dobbel gevinst: Fremskrittene som gjøres bidrar til velferd og helse samtidig som de skaper verdier og arbeidsplasser. Vi er overbevist om at det norske kreftforskning- og utviklingsmiljøet kan bety mye for et Norge i omstilling, samtidig som vi utvikler morgendagens kreftbehandling, sier Ketil Widerberg, daglig leder i Oslo Cancer Cluster.

 

Kontaktpersoner:

Oslo Cancer Cluster Inkubator: Bjørn Klem, daglig leder: e-post: bk@occincubator.com mobil: 924 161 56

Oslo Cancer Cluster: Ketil Widerberg, daglig leder: e-post: kw@oslocancercluster.no, mobil: 915 77 990

Thermo Fisher Scientific: Ole Dahlberg, adm.dir, e-post: ole.dahlberg@thermofisher.com, mobil 91108260 eller Geir Hetland, finansdirektør, e-post: geir.hetland@thermofisher.com, mobil: 98218280

 

Thermo Fisher Scientific:
Thermo Fisher Scientific i Norge (tidl Dynal Biotech) ble etablert i 1986. Selskapet har fokus på det diagnostiske markedet samt utvikling av nye former for immunterapi spesiellt innenfor kreftområdet. Kundeportoføljen består av mange av verdens største pharma og diagnostiske selskaper i verden. I 2014 hadde selskapet 180 ansatte og omsatte for 760 millioner. Selskapet har produksjonslokaler både i Oslo og Lillestrøm. Det norske selskapet er et datterselskap til Thermo Fisher Scientific som er et børsnotert selskap på NYSE. www.thermofisher.com

 

 

 

 

 

 

 

 

 

 

Cancer Crosslinks 2016 features thought leaders in immuno-oncology

Cancer Crosslinks 2016 on January 14 offers you an exciting program with international keynote speakers who made and make major contributions to advance immunotherapies against cancer. Already more than 120 delegates have signed up, but we have room for many more in the Kaare Norum Auditorium at Oslo Cancer Cluster Innovation Park. The conference is sponsored by BMS and Janssen.

 

 

The main theme for Cancer Crosslinks 2016 is: «The transversal impact of new treatments in Oncology and Hematology: tumor microenvironment, novel concepts, combinations and study design».

 

Some program highlights:

  • Professor Gordon Freeman, Dana-Farber Cancer Institute and Harvard Medical School, is one of the key persons behind today’s PD-1/ PD-L1 inhibitors. He will share his perspectives on PD-1 cancer immunotherapy. His talk will be complemented by case studies from Norway illustrating the broad impact of immune checkpoint inhibitors for a variety of cancers
  • Professor  Renier Brentjens, Memorial Sloan-Kettering Cancer Center, will shift the focus to hematological cancers and discuss the advancement of recombinant T-cell technologies including CAR-T-cell approaches for different indications. Norwegian experts will complement his talk with updates on novel immuno-oncology approaches being developed at UiO and OUS
  • Stefani Spranger from Professor Tom Gajewski’s lab, University of Chicago will provide the latest insights into the role of T-cell inflammed versus non-inflammed tumor microenvironment for immunotherapy
  • Last, but not least: a Norwegian patient will share his perspectives on the importance of novel cancer therapies

 

Travel expences
Participants working at hospitals and/or academic reserach centres whom have no sources for funding the participation will get flight or train ticket covered. How ever we do not cover local transportation to / from the airport. Flight or train tickets may be ordered by connecting to travel agency Berg-Hansen on e-mail:  bestilling@berg-hansen.no or phone  08050 between 08.00-17.00. The reference code is «OCC».

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

Presentations from Immuno-Oncology Meeting in Bergen

On November 11 Oslo Cancer Cluster, BMS and MSD hosted the 2nd  Immuno-Oncology Educational Meeting in 2015. 60 clinicians, researchers and other interested actors from the vibrant oncology environment in Bergen joined the meeting, listened to the excellent presentations and discussed with our speakers from the Center for Cancer Immune Therapy in Herlev, Professor Inger Marie Svane and Professor Mads Hald Andersen.  BTO kindly supported the meeting as local partner.

For those of you whom missed out on the meeting, please download the presentations below.

Photocure: First patient enrolled in Hexvix®/Cysview® Phase 3 study on bladder cancer

Oslo Cancer Cluster member Photocure announces that the first patient has been enrolled in the Hexvix/Cysview Market Expansion Phase 3 study on bladder cancer. The study will investigate the use of Hexvix/Cysview in the outpatient / surveillance setting and is designed to fulfill the FDA post marketing commitments. Results from the Phase 3 study are expected to be available in 2017.

The study is a prospective, multicenter Phase 3 study comparing the detection and potential positive impact on patient management of bladder cancer in the outpatient setting with Hexvix/Cysview using Blue Light enabled flexible cystoscopy versus white light flexible cystoscopy. Eighteen top rated cancer hospitals in the USA will participate in the study, which is planned to enroll approximately 360 patients with non-muscle invasive bladder cancer.

There are approximately 1.2 million flexible cystoscopy procedures conducted on a yearly basis in the United States. The use of Blue Light Flexible Cystoscopy with Hexvix/Cysview in the outpatient / surveillance setting could allow Urologists to detect recurrences at an earlier stage, which is of great clinical benefit. Furthermore, as has been demonstrated with the current use of Hexvix/Cysview during bladder cancer resection with blue light rigid cystoscopes, the addition of Hexvix/Cysview in the surveillance of bladder cancer patients may lead to better and earlier patient management decisions resulting in improved clinical outcomes and health economic savings.

Dr. Raj Pruthi, Professor and Chair, Department of Urology, University of North Carolina, Chapel Hill said: “The positive benefits of Hexvix/Cysview are well documented in numerous trials for patients undergoing bladder cancer resections during cystoscopy examination in the operating room. We are looking forward to conducting the study with Blue Light Flexible Cystoscopy with Hexvix/Cysview to confirm the benefits of this technology also in the outpatient setting. Early detection of more lesions is expected to result in better treatment decisions as well as more appropriate referrals and follow-up regimens, which in turn will reduce the burden on patients and the health care system.”

Kjetil Hestdal, President & CEO said: “This is an important milestone for Photocure as we seek to expand the use of Hexvix/Cysview into the bladder cancer surveillance market. Enabling Blue Light flexible cystoscopy with Hexvix/Cysview in the surveillance setting will allow patients with non-muscle invasive bladder cancer access to optimal treatment earlier, resulting in improved long-term benefits for these patients. While this trial is ongoing in the USA, we will be obtaining additional clinical and health economic data in EU from the use of Hexvix/Cysview in the same setting in order to optimize best clinical practices and patient outcomes.”

For more information about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT02560584

 

 

About Photocure ASA

Photocure ASA, 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 in disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions that 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 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®/Cysview® is approved in Europe, Canada and the USA.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

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

 

 

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 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.

 

Oncology Super Session in Stockholm

Oslo Cancer Cluster is hosting a Super Session at the Nordic Life Science Days in Stockholm. International thought leaders will discuss current game changing innovations and their impact on the industry in the years ahead.

Oncology is at the forefront of realizing the promises of precision medicine. Huge and complex datasets are exploited for novel drug development as well as for informed and real-time care decisions. Emerging Cancer immunotherapies represent a paradigm shift for cancer treatment triggering 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.

 

Moderator: Mr. Richard Godfrey, CEO, BergenBio, Norway

Session Outline:

 

Min Topic Speaker
5 Introduction by moderator ·        Dr. Richard Godfrey, CEO BerGenBio

 

10 Topic 1 –global company – perspectives from industry leader – Precision Medicine ·        Dr. Vaios Karanikas, Senior Biomarker and Experimental Medicine Leader, Tumor Immunology, Roche Pharmaceutical Research and Early Development, Innovation Center Zurich
10 Topic 2 – Digital Health company – Big Data / artificial intelligence -> impact on cancer R&D and care ·        Dr. Anthony Bak, Principal Data Scientist, Ayasdi
10 Topic 3 – global company – perspectives from industry leader – Immuno-Oncology ·        Dr. Tim Fisher, Global Lead, Immuno-Oncology / Oncology, Search & Evaluation, Bristol-Myers Squibb
25 Panel Discussion ·        All speakers, joined by Dr. Erik Lund, Director, Worldwide Licensing at MSD (Merck & Co., Inc.)

 

Target Audience: Start-ups, Biotechs, Pharma, investors, academic innovators, TTOs

 

Great media interest in immunotherapy against cancer

On June 11 Oslo Cancer Cluster and  Norwegian Cancer Society arranged a breakfast meeting on immunotherapy against cancer. Norwegian media showed huge interest in the topic. Below we have collected some of the coverage – and we know more is coming.

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 part of project that has successfully landed EU Horizon 2020 funding

Oslo Cancer Cluster member Vaccibody AS wil take part in SAPHIR, a 4 year collaborative research project that has succesfully raised 78 million NOK from the EU Horizon 2020 program. SAPHIR brings together interdisciplinary expertise from 14 academic institutions, 5 small and medium-sized enterprises  and 2 pharmaceutical companies. The project aims to improve animal production and health through development of improved vaccination strategies. 

Vaccibody is dedicated to the development of novel immunotherapies and vaccines for prevention and treatment of cancer and infectious diseases for human and veterinary purposes. For SAPHIR, Vaccibody will provide vaccines against Porcine Reproductive and Respiratory Syndrome Virus for evaluation in pigs. Upon successful completion of the SAPHIR project, Vaccibody will have increased expertise and network within the veterinary vaccine and administration field.

Tom Pike, Chairman and Acting CEO of Vaccibody, commented: “This is another example of how Vaccibody intends to broaden the use of our platform technology in collaboration with acknowledged partners. We recently attended the kick-off meeting in Paris and we are proud to be a part of this international consortium with expertise within veterinary vaccine development. The support from EU for collaborative initiatives like SAPHIR will allow Vaccibody to expand its experience of the technology within the veterinary field while the company remains fully focused on the clinical development of it’s lead drug candidate, VB10.16 for treatment of HPV16 induced precancer and cancer.”

 

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).

 

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).

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.

 

 

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

View videos from Cancer Crosslinks 2015

At this years Cancer Crosslinks we made short video interviews with presenters Professor Paul Baas, Professor Nicholas Navin, Professor Bjørn Tore Gjertsen and Professor Kimmo Porkka on their research and views on cancer treatments in the future. You may watch them below.

We would like to thank the presenters for taking the time to share their knowledge and our sponsors Bristol-Myers Squibb and Roche for making it possible to produce these videos.

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

 

Winners of Immuno-Oncology Call are: BerGenBio, Targovax and Ultimovacs

By deadline November 15, Oslo Cancer Cluster had received 9 applications for collaborative innovation projects addressing our Immuno-Oncology call on MNOK 1, 2.  From these,  three winners have been chosen, and those are: BerGen Bio, Targovax and Ultimovacs. Each company will receive MNOK 0,4 from Innovation Norway.

 

BergenBio will use the funding to prove that Axl kinase inhibition may provoke anti-tumour immune response
BerGenBio receives funding for the project Enhanced tumor immune activation by clinical Axl‐targeting agents, with partners from the University of Bergen, Oslo University Hospital and University of Texas. The goal of this project is to demonstrate that Axl receptor inhibition potentiates anti-­‐tumor immune responses against poorly immunogenic cancers and to develop improved clinical immunotherapeutic strategies based on Axl targeting.

– BerGenBio are very pleased to be one of the three companies to win an I-O innovation project. The award will allow the company to demonstrate that Axl kinase inhibition can play a key role in provoking anti-tumour immune response, and thus may be a valuable immunotherapy target. BerGenBio is a leader in the field of Axl kinase biology and the Company’s clinical candidate, BGB324, is the first selective Axl kinase inhibitor to be tested in the clinic, says Richard Godfrey, CEO BerGen Bio.
Targovax awarded an immuno-oncology innovation prize
The Immuno-Oncology prize from Oslo Cancer Cluster will contribute to the funding of Targovax´s development of new cancer vaccines, with focus on the new peptide vaccine TG03 for treatment of RAS mutated malignant melanoma.

– Targovax is proud to receive this prize and wants to thank Oslo Cancer Cluster for the grant.  This is a great acknowledgement and support of Targovax’s work to develop the new cancer vaccines in pipeline towards clinical testing, says Hanne Mette Kristensen, CEO Targovax.

 

Ultimovacs will use the funding to develop novel cancer therapy
Ultimovacs receives funding for the prjoect Re-targeting T-cells against cancer – development of T-cell receptors directed against telomerase, with partner Oslo University Hospital. The overall goal of the project is to develop novel cancer therapy by reprogramming immune cells to target the universal tumour antigen telomerase.

– Ultimovacs are very happy and proud to be one of the winners of this funding granted by Oslo Cancer Cluster and Innovation Norway. The funding gives us the opportunity to expand our technological platform. This project has the potential to combine vaccine technology and cell therapy in the treatment of patients with advanced cancer. The research is an example of the strength of collaboration between industry and academia, says Øyvind Arnesen, CEO Ultimovacs.

 

Strength within Immuno-Oncology in Norway proven
Jutta Heix, International Advisor in Oslo Cancer Cluster and project coordinator of the Norwegian Immuno-Oncology Consortium, is very pleased with this years call.

– We are very pleased about the significant interest and very positive feedback from our members for this funding opportunity. The number and quality of the applications and the breadth of the topics confirms the particular strength in the cancer immunotherapy area in Norway. Based on the feedback from last year’s winners we know that the funding despite the relatively small amount, truly makes a difference and helps to advance the immuno-oncology portfolio within the cluster. Therefore we continuously work to increase the funding available for our members, says Jutta Heix, International Advisor in Oslo Cancer Cluster.

 

 

Call in Immuno-Oncology: 9 applications received

By deadline November 15, Oslo Cancer Cluster received 9 applications for collaborative innovation projects addressing our Immuno-Oncology call on MNOK 1, 2. The applications are now being evaluated and the winners will be announced on Oslo Cancer Cluster`s Christmas Meeting, December 1st.

– We are very pleased about the significant interest and very positive feedback from our members for this funding opportunity. The number and quality of the applications and the breadth of the topics confirms the particular strength in the cancer immunotherapy area in Norway. Based on the feedback from last year’s winners we know that the funding despite the relatively small amount, truly makes a difference and helps to advance the immuno-oncology portfolio within the cluster. Therefore we continuously work to increase the funding available for our members, says Jutta Heix, International Advisor in Oslo Cancer Cluster.

Evaluation process

A selection committee with representatives from Oslo Cancer Cluster Incubator, Innovation Norway, with academic, clinical and financing experts as advisors will review the applications. Projects are selected based on their novelty, commercial potential and feasibility. It is important that the funding must make a significant difference for the applicant. This can be in the sense that the project will not be materialized without the funding or that the project will be better (e.g. broader in scope or deeper in its investigation. In addition all applications are reviewed by Innovation Norway to see if they qualify for other funding schemes

 

Questions?

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

 

 

 

 

 

 

 

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.

The Minister of Education pre launched the long-term plan for research and education with Lytix Biopharma

Yesterday Minister Røe Isaksen and the Minister of Health Bent Høie visited Lytix Biopharma at the Department of Cell therapy at the Cancer Research Institute/Oslo University Hospital. The background is that the Government will present a long-term plan for research and higher education on October 8. This white paper will outline how the government will prioritize the use of research resources in the coming years.

Health, nutrition and outstanding research are some of the priority areas, and the long-term plan will also follow up on Health&Care21. Both Ministers pointed out that Lytix Biopharma is a good example of several aspects of the plan.

CEO Unni Hjelmaas in Lytix Biopharma appreciate the contact with both ministries.

Right focus from the Government
– It is an honor for Lytix Biopharma to be part of this and at the same time be acknowledged for many of the objectives set in the long term plan for research and higher education as well as the Health&Care21, says Hjelmaas. We are ensured that the Government has the right focus after the insight we got into the long term plan today. We now look forward to seeing this be moved from words to action.

The General Manager of the Pharma Industry Association in Norway Karita Bekkemellem was also present. She was very enthusiastic after the meeting. – This is a recognition that the pharma industry is an important contributor to good patient treatment. It is positive that the Government now focus on an active public and academic partnership with the pharma industry. We look forward to contribute, she continues.

Long-term research and higher education
The Government announced in May that it will present a long-term plan for research and higher education in autumn 2014. The objective is a strategic, coordinated and predictable research and higher education policy that lays the foundation for Norway to meet the challenges and opportunities ahead of us.

The long-term plan is a tool to target efforts on areas where Norway has strategic advantages, and to meet future needs for knowledge in key areas. At the same time the long-term plan allow for crossing borders and for innovative research that can give us new insight in the long term.

 

Lytix Biopharma
Lytix Biopharma’s technology is based on nature’s own defense mechanism. The membranes of bacteria and cancer cells are destroyed. Our technology has the potential to meet two substantial medical challenges; treatment of infections regardless of resistance and cancer therapy that activates the patient`s own immune system. Lytix Biopharma’s strategy is to develop its drug candidates to Proof of Concept, and then bring in partners for the final stages of product development and commercialization. See www.lytixbiopharma.com.

Lytix Biopharma awarded Nordic Stars 2014

Oslo Cancer Cluster member Lytix Biopharma is one of three biotech companies selected as Nordic Stars 2014. The prize is given to companies that the organizers of the Nordic Life Science Days sees as extra promising.

The Nordic Stars Awards have been established to shed some extra light on those companies Nordic Life Science Days see really showcase how innovative Nordic companies can be.

– This is a great honour, says Unni Hjelmaas, CEO at Lytix Biopharma. – We appreciate that we are noticed in an active Nordic market with many promising companies. To receive such an award makes us aware that others are watching us and gives us an extra motivation to prove that it is possible for innovative Nordic companies to succeed.

– With this price and the attention given to us we have a good basis for dialogue with potential partners. We are very grateful that professionals outside our company believe in what we do, said Knut Eidissen, Chairman of the Board of Lytix Biopharma

 

Lytix Biopharma:
Lytix Biopharma’s technology is based on nature’s own defense mechanism. The membranes of bacteria and cancer cells are destroyed. Our technology has the potential to meet two substantial medical challenges; treatment of infections regardless of resistance and cancer therapy that activates the patient`s own immune system. Lytix Biopharma’s strategy is to develop its drug candidates to Proof of Concept, and then bring in partners for the final stages of product development and commercialization. See www.lytixbiopharma.com.

Nordic Life Science Days:
Nordic Life Science Days is the Nordic region’s largest partnering conference for the global life science industry. The conference attracts leading decision-makers in the life science sector, including the bioengineering, pharmaceuticals and Med Tech segments, along with investors, research institutions, politicians and authorities. This year’s Nordic Life Science Days event is taking place in partnership with Oslo Cancer Cluster and Toulouse Cancer-Bio-Santé Cluster.

This year they have:
840+ registered delegates
570+ companies/organizations
26 countries represented
7000+ meeting requests in partneringONE
1400+ accepted meetings
480+ licensing opportunities

Strong Scandinavian Cancer Immunotherapy Mission

A very strong Scandinavian immunotherapy delegation is in the US September 15 – 19 to meet peers from some of the most prominent institutions “over there”. Medicon Valley Alliance is arranging this unique opportunity and have kindly invited members of Oslo Cancer Cluster to join.

As of now 22 delegates from Scandinavia will visit some of the world’s leading universities, research groups, clinical centers and big pharmaceutical companies working within the immunotherapy field. This partnering mission will thus enable the delegates to learn more about the latest research and business trends within immunotherapy in the US while expanding their network – all in just one week.

Strong Norwegian players in the field of immuno-oncology; Inven2, Targovax, Ultimovacs, Nextera and PCI Biotech are joining the delegation from Oslo Cancer Cluster`s side. Immuno-oncology is one of the hottest research topics globally now, and the Scandinavian players are considered to be strong in this area.

Download program

CANCER IMMUNOTHERAPY PARTNERING MISSION 2014

Cancer Immunotherapy Partnering Mission
Washington DC – Baltimore – NYC – Boston

September 15 – 19, 2014

Delegates will visit:

  • The David H. Koch Institute for integrative cancer research @ MIT
  • Merck Research Laboratories
  • MASSBIO event: Cancer Immunotherapy – Investment and Partnering trends
  • Dana-Farber cancer institute
  • Novartis institute for Biomedical Research
  • NYU Langone Medical center/Perlmutter Cancer Center
  • Cancer Research Institute
  • Mount Siani Health System in NYC
  • Bristol-Myers Squibb
  • University of Pennsylvania, Perelman School of Medicine
  • John Hopkins Hospital, the Sidney Kimmel Comprehensive Cancer Center
  • National Institute of Health, National Cancer Institute

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.”

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

Ketil Widerberg on Pharma TV

In April 2014, Pharma TV interviewed Ketil Widerberg, General Manager of Oslo Cancer Cluster. Watch the interview and learn more about how Oslo Cancer Cluster works to develop new diagnostics and medication.

Watch the interview here.

In the interview Ketil Widerberg also explains to Fintan Walton from Pharma TV how Oslo Cancer Cluster`s core expertise in the field of Immuno-Oncology makes the cluster well positioned to contribute in this field and how several research projects and ongoing clinical trials will contribute to an exciting pipeline of novel cancer immunotherapies.

 

 

ECCP Oncology Track Program

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.

 

Innovation Norway: Technology Incubator in Asia

Are you aiming for Asian markets? Innovation Norway presents the Tech Incubator Program – TINC

TINC in Silicon Valley has created great opportunities for Norwegian tech entrepreneurs and has been fundamental in Innovation Norway’s efforts towards global entrepreneurs.
These days the concept is extended to Asian markets with Singapore as the epicenter. Please find more information on TINC Asia here:  www.innovasjonnorge.no/TINCasia.

Innovation Norway’s competence programs for global entrepreneurs in Norway and abroad are collectively presented as Global Entrepreneurship Programs. Find more information www.innovasjonnorge.no/GE.

Please do not hesitate to ask questions to Ingvild von Krogh Strand, Program Manager: Ingvild.von.krogh.strand@innovationnorway.no

 

Targovax AS is registered on the NOTC-list

Targovax AS is registered on the NOTC-list from June 16th, 2014, with ticker code TRVX. The company has issued 9 429 404 shares, each at par value NOK 0.10.

All shares are registered in VPS with ISIN code NO 001 0689326. Based on the most recent capital increase, June 4th, 2014, where the shares were signed up for NOK 21.50, the company has a post money price of NOK 202 732 186. The company has entered an agreement wiht NOTC AS and will be able to use the reporting system from June 16th, 2014.

Immunotherapy against pancreatic cancer
Targovax is a cancer biotech-company started in October 2010 to develop targeted immunotherapy in the form of therapeutic cancer vaccines. Lead candidate 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.

Please find more info on the web page www.targovax.com

FACTS:

Targovax
Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccines based on pioneering research into RAS mutations in 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 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 1-8 weeks after surgery. 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.

 

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.

 

Pharmaconutrition products for cancer patients

Smartfish is a Norwegian company developing synergistic omega 3 based pharmaconutrition products. Smartfih is now studying the effect of their phamaconutrition on the immune system, and would like to get in contact with Norwegian collaborators.

Smartfish joined the Oslo Cancer Cluster in 2014 and currently have two products on the market that have been clinically developed for the use of cancer patients; Nutrifriend 1100 and Nutrifriend 600. Their patented technology is basis for the product range of orally applied liquid emulsions ecpecially suitable for cancer patients.

Looking for collaborators
“Our core expertise as a company is to develop immune-modulating medical nutrition. Currently we have collaborations with both UCLA in the US and Karolinska in Sweden on a new type of medical nutrition we are developing containing curcumine. Recent findings suggests an effect on the natural killer cells (NK-cells) of the immunesystem, which are important in combating cancer,” says Janne Sande Mathisen, Co-Founder and R&D, Smartfish.

Smartfish is now looking for Norwegian collaborators within immuno-oncology/immunetherapy. Interested parties may contact Sande Mathisen directly:
E-mail: janne@smartfish.no or Mobile: + 47 93 20 87 02.

 

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.

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.

 

 

 

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.