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.

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.

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.

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.

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.

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.

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.