Photo: Christopher Olssøn/Oslo Cancer Cluster

News from our members

There have been several exciting developments from our members over the last week. Here are three condensed news from the Norwegian biopharma sphere that we wish to highlight.

Promising combination treatment

Our member Targovax, a Norwegian immuno-oncology company, has announced some encouraging data from one of their clinical studies.

The study is directed towards patients with mesothelioma, a type of cancer that develops in the thin layer of tissue that covers many of the internal organs, for example the lining of the lungs or chest wall.

The patients are given a combination treatment consisting of Targovax’s own oncolytic virus called “ONCOS-102” and the standard of care: chemotherapy.

The preliminary data show a numerical advantage in progression-free survival for the patients that have received ONCOS-102. There has also been a robust immune activation in the experimental group. It has also been shown that the combination treatment is well tolerated by the patients.

Targovax are now in ongoing discussions with a pharmaceutical company about a prospective partnership in order to launch a checkpoint inhibitor combination study.

View the entire press release from Targovax

US patent for Norwegian cancer technology

Our member PCI Biotech, a Norwegian biopharmaceutical company, has secured a US patent for one of their cancer treatment technologies.

The treatment is called “fimaVACC” and is based on a type of light technology invented here in Norway at the Norwegian Radium Hospital.

The technology helps to transport cancer medicine more effectively to the targeted cancer cells. In this case, the technology enhances the effect of other cancer vaccines.

The US patent is for the use of fimaVACC together with cytokines, a small protein that is involved in cell signalling that regulates the immune responses.

The combination treatment has shown to be effective when enhancing the immune responses in cancer patients to fight off cancer.

Per Walday, CEO of PCI Biotech, said: “There are many vaccines under development utilising cytokines to elicit immune responses. The US patent granted today is important for PCI Biotech’s development strategy, as it supplements our ability to generate an internal future vaccine pipeline, in addition to bringing value for the fimaVACC technology in partnering efforts.”

View the entire press release from PCI Biotech

New results from clinical study

Our member BerGenBio, a Norwegian biopharmaceutical company, has given an update on one of their phase II clinical trials.

The phase II trial aims to determine the clinical efficacy of one of the drugs BerGenBio has developed, namely “bemcentinib”.

Bemcentinib is an AXL inhibitor, a novel type of cancer therapeutic agent.

BerGenBio can now show that the first stage clinical efficacy endpoint has been met.

The clinical trial is evaluating a combination treatment, consisting of bemcentinib and the immunotherapy drug Keytruda.

The patients who have been treated in this trial all have non-small cell lung cancer (NSCLC) and have previously failed checkpoint inhibitor therapy.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: “Reversing resistance to immune checkpoint inhibitors in patients who have relapsed on immunotherapy is a highly desirable alternative to the second-line chemotherapy standard-of-care. We are very excited with these early results in this challenging setting and look forward to expanding the study to confirm these findings and reporting comprehensive translational insight.”

View the entire press release from BerGenBio

 

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The speakers Dr. Sara Mastaglio and Dr. Sara Ghorashian came to Oslo to share their research in T cell immunotherapy with the Norwegian research environment. Photo: Christian Tandberg

A café to advance T cell research

Two of the speakers discussing with each other and laughing..

We want to accelerate cancer research in T cell immunotherapy!

In order to promote research collaboration, spread knowledge and exchange ideas, Oslo Cancer Cluster arranged a seminar together with Nature Research this week. The topic was T Cell Immunotherapy: Advances, Challenges and Future Directions.

What is T cell immunotherapy?

T cell immunotherapy is a rapidly growing area of research in cancer treatment. The research focuses on finding new ways to trigger the immune system to kill cancer cells.

The treatment method involves collecting T cells (a type of immune system cell) from a patient’s blood sample. The T cells are then modified in the laboratory so they will bind to cancer cells and destroy them.

One way to do this is called CAR T therapy. This involves adding a gene for a special receptor that binds to a specific protein (also called an antigen) on the patient’s cancer cells. The special receptor is called a chimeric antigen receptor (CAR). These cells are grown in large numbers in the laboratory and then infused in the patient to create an immune response.

Read more about CAR T cell therapies in this article from The National Cancer Institute

Image of researchers attending Nature Café on T cell immunotherapy in Oslo.

Many researchers attended the Nature Café for the opportunity to learn more about recent advances in T cell immunotherapy. Photo: Christian Tandberg

Why is cell therapy important?

Research into T cell immunotherapy is important, because it has the potential to treat and cure cancer. T cell immunotherapy can help cancer patients live longer and potentially has fewer side effects than traditional treatment methods, such as chemotherapy, radiation therapy and surgery.

However, more research is needed to make T cell immunotherapy work on all kinds of cancer. For example, some patients with haematologic cancer, cancers that develop in the blood-forming tissue, relapse into disease after treatment. Moreover, T cell immunotherapy does not work on all patients with solid cancer tumours yet.

Researchers wish to know why some cancers are resistant to T cell immunotherapy and why some patients acquire resistance to the treatment over time. Some patients also experience toxic side effects to T cell immunotherapy. Moreover, researchers are continually searching for possible new antigens (proteins) to target.

There are still many unanswered questions and that is why we need to accelerate the research.

Two researchers in the audience asking questions.

Members of the audience were eager to find out more about this rapidly growing area of research. Photo: Christian Tandberg

Why did we arrange this event?

The Norwegian research environment in cancer immunotherapy is world-class. But Norway is a small country and researchers need access to international partners and expertise to develop their findings.

The purpose of the event was to highlight recent findings in T cell immunotherapy. There was also the opportunity to discuss ongoing challenges and opportunities in the development of these types of treatments.

Among the guests were several prominent Norwegian cancer researchers, the pharma industry, hospital clinicians, biotech start-ups, and more. During the seminar, many of the participants in the audience asked follow-up questions and the café breaks were buzzing with conversations between researchers.

Three researchers in the audience discussing with each other.

The event was an opportunity to discuss with and learn from prominent researchers in the cell therapy field. Photo: Christian Tandberg

Watch the video below to see a few of the participants’ reactions:

Meet the speakers

The moderator for the event was Saheli Sadanand, Associate Editor, Research Manuscripts at Nature Medicine. Photo: Christian Tandberg

The moderator for the event was Saheli Sadanand, Associate Editor, Research Manuscripts at Nature Medicine. Photo: Christian Tandberg

 

The first speaker was Sara Ghorashian from the University College London

The first speaker was Sara Ghorashian from the University College London. Dr. Ghorashian is a consultant Paediatric Haematologist at Great Ormond Street Hospital for Children in London, and the co-investigator or lead UK investigator for six different CAR T cell clinical trials. She talked about her research to improve outcomes of CAR T cell therapy in patients with acute lymphoblastic leukemia. This is a type of cancer in the blood. Photo: Christian Tandberg

 

Attilio Bondanza, who is a physician-scientist and the CAR T cell program leader at Novartis Institutes of Biomedical Research in Basel, Switzerland.

The second speaker was Attilio Bondanza, who is a physician-scientist and the CAR T cell program leader at Novartis Institutes of Biomedical Research in Basel, Switzerland. Before joining Novartis, Dr. Bondanza was a professor at the San Raffeale University Hospital, where he led the Innovative Immunotherapies Unit. Dr. Bondanza talked about his work to model CAR T cell efficacy and CAR T cell-induced toxicities pre-clinically. Photo: Christian Tandberg

 

Sara Mastaglio, who is a physician scientist specialising in haematology at San Raffaele Scientific Institute, in Milan

The third speaker was Sara Mastaglio, who is a physician scientist specialising in haematology at San Raffaele Scientific Institute, in Milan. She has been actively involved in the development and clinical application of CAR T cell therapies. Dr. Mastaglio discussed her research on genome-edited T cells for the treatment of haematological malignancies. Photo: Christian Tandberg

 

Aude Chapuis, who is an assistant member of the Fred Hutchinson Cancer Research Center in Seattle

The last speaker was Aude Chapuis, who is an assistant member of the Fred Hutchinson Cancer Research Center in Seattle. In addition to running a lab, she sees patients as an attending physician at the Fred Hutch Bone Marrow Transplant Program at the Seattle Cancer Care Alliance. Dr. Chapuis discussed mechanisms of response and resistance to instruct next generations of T cell receptor gene therapy. Photo: Christian Tandberg

 

Want to find out more?

In February 2020, the journal Nature Research will publish an article with a more detailed overview of the speakers, their presentations and the research. We will provide a link here when it is available!

If you enjoyed this event, please subscribe to our newsletter to receive invitations to our upcoming events and a digest of our latest news.

 

We want to thank our sponsors for helping us make this event happen.

Sponsor logos: Novartis Oncology, ThermoFisher Scientific and Celgene

Sune Justesen and Stephan Thorgrimsen from Immunitrack are pleased to receive the Eurostars funding to continue to develop the company's prediction tools. Photo: Immunitrack

New tool to improve cancer vaccines receives funding

Sune Justesen and Stephan Thorgrimsen from Immunitrack

Oslo Cancer Cluster member Immunitrack has been awarded a grant from Eurostars to develop their prediction tool for cancer vaccines.

Immunitrack is a biotech company that develops software, which predicts immune responses and assesses new cancer vaccines.

Developing a new vaccine can be a lengthy and expensive process, with a high risk of failure. One key to success is being able to predict how the patient’s immune system will react, so drug developers can bring forth therapies that mobilize the immune system to fight the disease. Immunitrack’s tools can help developers predict the impact of a new drug on the patient’s immune system, before entering clinical trials.

Eurostars supports international innovative projects and is co-funded by Eureka member countries and the European Union Horizon 2020 framework programme. The funding will be used by Immunitrack over a 24-month period for the ImmuScreen Project, to develop a new prediction tool. It will both improve how cancer vaccines work and how to track patients’ immune responses.

“This Eurostar project will give additional momentum to the ongoing development of a best in class neo-epitope prediction tool, PrDx TM, by Immunitrack,” says Sune Justesen, CSO at Immunitrack.

Immunitrack will receive a total of approximately €750 000 from Eurostars, together with the Centre for Cancer Immune Therapy (CCIT), based in Herley, Denmark. CCIT aims to bridge the gap between research discovery and clinical implementation of treatments in the field of cancer immunotherapy.

“The collaboration with the Danish Cancer Center for Immune Therapy, is certainly an important step in validating and implementing PrDx, in the immune therapy treatment of cancer patients,” says Sune Justesen, CSO at Immunitrack.

Immunitrack will handle the software development, while CCIT performs the in vitro validation. The clinical validation will be carried out in melanoma patients. The results will help to characterize immune responses and help to understand why some tumours are immune to novel cancer vaccines.

 

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The High Throughput Screening Lab at SINTEF. Photo: Thor Nielsen / SINTEF

SINTEF to develop methods in immuno-oncology

The Cell Lab at SINTEF. Photo: Thor Nielsen / SINTEF

SINTEF and Catapult Life Science are looking for new partners to develop methodology for cancer immunotherapy.

“We want to develop methods within immunotherapy, because this is currently the most successful strategy for improving cancer treatments and one of the main directions in modern medicine,” says Einar Sulheim, Research Scientist at SINTEF.

The Norwegian research organization SINTEF is an Oslo Cancer Cluster member with extensive knowledge in characterisation, analysis, drug discovery and development of conventional drugs.

The new project on methodology for cancer immunotherapy recently started in April 2019 and is a collaboration with Catapult Life Science, a new Oslo Cancer Cluster member. The aim is to help academic groups and companies develop their immunotherapy drug candidates and ideas.

Help cancer patients

Ultimately, the main aim is of course that the project will benefit cancer patients. Immunotherapy has shown to both increase life expectancy and create long term survivors in patient groups with very poor prognosis.

“We hope that this project can help streamline the development and production of immunotherapeutic drugs and help cancer patients by helping drug candidates through the stages before clinical trials.” Einar Sulheim, Research Scientist at SINTEF

 

Develop methodology

The project is a SINTEF initiative spending NOK 12,5 million from 2019 to 2023. SINTEF wants to develop methodology and adapt technology in high throughput screening to help develop products for cancer immunotherapy. This will include in vitro high throughput screening of drug effect in both primary cells and cell lines, animal models, pathology, and production of therapeutic cells and antibodies.

 

High throughput screening is the use of robotic liquid handling systems (automatic pipettes) to perform experiments. This makes it possible not only to handle small volumes and sample sizes with precision, but also to run wide screens with thousands of wells where drug combinations and concentrations can be tested in a variety of cells.

 

The Cell Lab at SINTEF. Photo: Thor Nielsen / SINTEF

The Cell Lab at SINTEF. Photo: Thor Nielsen / SINTEF

 

Bridging the gap

Catapult Life Science is a centre established to bridge the gap between the lab and the industry by providing infrastructure, equipment and expertise for product development and industrialisation in Norway. Their aim is to stimulate growth in the Norwegian economy by enabling a profitable health industry.

“In this project, our role will be to assess the industrial relevance of the new technologies developed, for instance by evaluating analytical methods used for various phases of drug development.” Astrid Hilde Myrset, CEO Catapult Life Science

A new product could for example be produced for testing in clinical studies according to regulatory requirements at Catapult, once the centre achieves its manufacturing license next year.

“If a new method is intended for use in quality control of a new regulatory drug, Catapult’s role can be to validate the method according to the regulatory requirements” Myrset adds. 

SINTEF and Catapult Life Science are now looking for partners.

Looking for new partners

Einar Sulheim sums up the ideal partners for this project:

“We are interested in partners developing cancer immunotherapies that see challenges in their experimental setups in terms of magnitude, standardization or facilities. Through this project, SINTEF can contribute with internal funding to develop methods that suit their purpose.”

 

Interested in this project?

Nobel Laureate Dr James Allison and oncologist Dr Padmanee Sharma will become Strategic Advisors for our member, the Oslo-based biotech company Lytix Biopharma. Photo: Shutterstock

Nobel Prize winner joins Lytix Biopharma

Dr James Allison, Dr Padmanee Sharma

The Nobel Laureate Dr James Allison and oncologist Dr Padmanee Sharma will become strategic advisors for our member Lytix BioPharma.

Oslo Cancer Cluster’s member Lytix BioPharma announced this week that the cancer researchers and married couple Dr James Allison (PhD) and Dr Padmanee Sharma (MD) will join their Scientific Advisory Board.

Dr James Allison was, together with Dr Tasuku Honjo, awarded the 2018 Nobel Prize in Medicine last December. The renowned cancer researchers received the award for their ground-breaking work in immunology. It has become the basis for different immunotherapies, an area within cancer therapy that aims to activate the patient’s immune system to fight cancer.

Dr Sharma is a distinguished oncologist, who has focused her work on understanding different resistant mechanisms in the immune system. These resistant mechanisms sometimes hinder immunotherapies from working on every cancer tumour and every cancer patient.

Lytix Biopharma is a biotech company, located in the Oslo Cancer Cluster Incubator, that develops novel cancer immunotherapies. They are making an “oncolyctic peptide” – a drug with the potential to personalize every immunotherapy to fit each patient.

  • Please visit Lytix BioPharma’s official website for more information about their product

Edwin Clumper, CEO of Lytix BioPharma, expressed how thrilled he was to welcome Dr Allison and Dr Sharma:

“We are honoured that they have offered their support to further the development of our oncolytic peptides with the aim to tackle tumour heterogeneity – an unresolved challenge in cancer treatment.”

 

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Photo: Thomas Brun / NTB

Ultimovacs enters the Oslo Stock Exchange

Ultimovacs enter Oslo Stock Exchange

Oslo Cancer Cluster member Ultimovacs, a Norwegian cancer vaccine company, has raised NOK 370 million and entered the Oslo Stock Exchange on Monday 3 June 2019.

There was a stir of interest among both national and international investors when Ultimovacs announced they will enter the Oslo Stock Exchange. Several interested parties have now become shareholders in the company, totalling approximately 1 500 shareholders.

“It is good for the Norwegian health industry and for Ultimovacs when national and international investors show the company this kind of trust. In today’s uncertain market, it is especially nice with such a large interest, from both international investors and small savers. I look forward to following the company further,” says Jonas Einarsson, Chairman of the Board in Ultimovacs and Managing Director in Radforsk.

The funds that Ultimovacs has raised will go to financing the development of their universal cancer vaccine, UV1. A large clinical study will document the effect of the vaccine. UV1 will be combined with other immunotherapies in patients with malignant melanoma (a type of skin cancer) at around 30 hospitals in Norway, Europe, USA and Australia.

Ultimovacs has already run two successful clinical trials of the vaccine on patients with lung cancer, prostate cancer and malignant melanoma.

“The cancer vaccine has shown promise in the studies we have conducted at the Norwegian Radium Hospital. Based on the results, we have established a development programme to document that our vaccine has effect on cancer patients. I am very happy that we now have entered the Oslo Stock Exchange. It means that the practical conditions are in place to put our development programme into action,” said Øyvind Kongstun Arnesen, Chief Executive Officer in Ultimovacs.

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From the left: Hakan Köksal, PhD student, and Pierre Dillard, scientist, are splitting cells in the lab at Oslo Cancer Cluster Incubator. They are two of the scientists behind the new Norwegian study described in this article.

The first Norwegian CAR

Dr. Pierre Dillard and Hakan Köksal are part of the team behind the new study on CD37CAR T-cell therapy for treatment of B-cell lymphoma.

Made in Oslo by a team of researchers from Oslo University Hospital, the first ever Norwegian CAR T cell is now a fact. A potential treatment based on this result depends on a clinical study.

A new Norwegian study shows a genetically modified cell-line with great potential as treatment for patients that are not responding to established CAR T cell therapies. This form of immuno-therapy for cancer patients has recently been approved in many countries, including Norway.

“We hope that the Norwegian authorities will be interested in transforming this research into benefits for Norwegian patients.” Hakan Köksal

 

 

What is a CAR?

Before we go into the research, let us clarify an essential question. What is a CAR? Chimeric antigen receptor (CAR) T cells are T cells that have been genetically engineered to produce an artificialreceptorwhich binds a protein on cancer cells.

How does this work? T cells naturally recognize threats to the body using their T cell receptors, but cancer cells can lock onto those receptors and deactivate them. The new CAR T cell therapies are in fact genetic manipulations used to lure a T cell to make it kill cancer cells. This is what a CAR is doing, indeed CARs replace the natural T-cell receptors in any T cells and give them the power to recognize the defined target – the cancer cell.

CAR-T cell therapy is used as cancer therapy for patients with B-cell malignancies that do not respond to other treatments.

 A severe consequence of using CAR T cell therapy is that it effectively wipes out all the B cells in the patient’s body — not only the cancerous leukemia cells or the lymphoma, but the healthy B cells as well. Since B-cells are an important part of the immune system, it goes without saying that the treatment comes with risks.

Micrograph of actin cytoskeleton of T-cells. The cell is about 10µm in diameter. Photo: Pierre Dillard

Micrograph of actin cytoskeleton of T-cells. The cell is about 10µm in diameter. Photo: Pierre Dillard

T cells: T lymphocytes (T cells) have the capacity to kill cancer cells. These T cells are a subtype of white blood cells and play a central role in cell-mediated immunity.

 

Made in Norway  

Now let us move on to the new research. This particular construct was designed from an antibody that was isolated in the 1980’s at the Radium Hospital in Oslo.

The CAR construct was designed, manufactured and validated in two laboratories in the Radium Hospital campus. One is the laboratory of Immunomonitoring and Translational Research of the Department of Cellular Therapy, OUH, located at the Oslo Cancer Cluster Incubator. This laboratory is led by Else Marit Inderberg and Sébastien Wälchli. The other is the laboratory of the Lymphoma biology group of the Department of Cancer Immunology, Institute for Cancer Research, OUH. This laboratory is led by June Helen Myklebust and Erlend B. Smeland.

“Even the mouse was Norwegian.” Hakan Köksal

The pre-clinical work that made the Norwegian CAR was completed in March 2019.

In the research paper “Preclinical development of CD37CAR T-cell therapy for treatment of B-cell lymphoma”, published in the journal Blood Advances, the research team tests an artificially produced construct calledCD37CAR and finds that it is especially promising for patients suffering from multiple types of B-cell lymphoma. This may be treated successfully with novel cell-based therapy.

It now needs to be approved by the authorities and gain financial support to be further tested in a clinical study in order to benefit Norwegian patients.

 

The first CAR-therapy

CAR-based therapy gained full attention when the common B-cell marker CD19 was targeted and made the basis for the CAR T cell therapy known as Kymriah (tisagenlecleucel) from Novartis.

It quickly became known as the first gene therapy allowed in the US when it was approved by the US Food and Drug Administration (FDA) just last year, in 2018, to treat certain children and young adults with B-cell acute lymphoblastic leukemia. Shortly after, the European Commission also approved this CAR T cell therapy for young European patients. The Norwegian Medicines Agency soon followed and approved the treatment in Norway.

“CD19CAR was the first CAR construct ever developed, but nowadays more and more limitations to this treatment have emerged. The development of new CAR strategies targeting different antigens has become a growing need.” Dr. Pierre Dillard

 

Not effective for all

Although the CD19CAR T cell therapy has shown impressive clinical responses in B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma, not all patients respond to this CAR T treatment.

In fact, patients can become resistant to CD19CAR. Such relapse has been observed in roughly 30% of the studies of this treatment. Thus, alternative B-cell targets need to be discovered and evaluated. CD37 is one of them.

“You could target any antigen to get a new CAR, but it is always a matter of safety and specificity.” Hakan Köksal said.

Dr. Pierre Dillard and Hakan Köksal are part of the team behind the new study on CD37CAR T-cell therapy for treatment of B-cell lymphoma.

Dr. Pierre Dillard and Hakan Köksal are part of the team behind the new study on CD37CAR T-cell therapy for treatment of B-cell lymphoma.

 

The Norwegian plan B

The novel Norwegian CAR T is the perfect option B to the CD19CAR.

 “The more ammunition we have against the tumours, the more likely we are to get better response rates in the patients.” Hakan Köksal

The CD37CAR T cells tested in mouse models in this Norwegian study, show great potential as treatment for patients that are not responding to the established CD19CAR-treatment.

“More and more labs are studying the possibility of using CAR therapy as combination, i.e. CAR treatments targeting different antigens. Such a strategy will significantly lower the probability of patients relapsing.” Dr. Pierre Dillard said.

The CD37CAR still needs to be tested clinically. The scientists at OUS underline the importance of keeping the developed CD37CAR in Norway and having it tested in a clinical trial.

It is a point to keep it here and potentially save patients here. We would like to see the first CD37CAR clinical study here in Norway.” Hakan Köksal

 

More from the Translational Research Lab of the Department of Cellular Therapy, OUH: 

 

Encouraging news from BerGenBio

Woman in lab studying test tube samples.

A second group of patients have been added to an ongoing phase II clinical study of a drug combination to treat lung cancer.

 

The ongoing trial is a collaborative effort between two members of Oslo Cancer Cluster: Norwegian biopharmaceutical company BerGenBio and US-based pharmaceutical company Merck (known as MSD in Europe). It involves an kinase inhibitor called bemcentinib, developed by BerGenBio, in combination with an immunotherapy drug called Keytruda (also known as pembrolizumab) from MSD.

 

“Throughout 2018, we reported encouraging updates from our ongoing proof-of-concept phase II clinical trial assessing bemcentinib in combination with Keytruda in advanced lung cancer patients post chemotherapy.”
Richard Godfrey, Chief Executive Officer, BerGenBio

 

The second group will involve patients that have been treated with immunotherapy before, but that have experienced a progression of the disease. There are various treatments available for patients with non-small cell lung cancer, but patients often acquire resistance to treatment. New treatments that can overcome these resistance mechanisms are therefore urgently needed.

 

“I am pleased that we are now extending the ongoing trial to test our hypothesis also in patients showing disease progression on checkpoint inhibitors.”
Richard Godfrey, Chief Executive Officer, BerGenBio

 

The aim is to evaluate the anti-tumour activity of this new drug combination. Preliminary results from the second patient group of the study are expected later this year. BerGenBio is in parallel also developing diagnostic tools to see which patients are most likely to benefit from their drug.

 

The decision to extend the trial was based on new positive results from pre-clinical studies, which were presented at the American Association of Cancer Research (AACR) earlier this week. The results open for the possibility to use bemcentinib both as a monotherapy and in combination with other cancer treatments on a broad spectrum of cancers.

 

 

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Dr. Jon Amund Kyte is the new Head at the Department of Experimental Cancer Treatment at OUH.

Attracting clinical trials to Norway

Dr. Jon Amund Kyte at Oslo University Hospital (OUH) and Oslo Cancer Cluster share the common goal of bringing more clinical trials to Norway.

 

Jon Amund Kyte is the new Head at the Department of Experimental Cancer Treatment at OUH. He also runs three separate clinical trials and is the leader of a research group at the Department of Cancer Immunology, where he develops novel CAR T cell therapy and conducts translational studies.

Kyte aims to increase the number of and improve the quality of clinical trials in Norway. He says this will contribute to more patients gaining access to novel cancer treatments and to improving the efficacy of cancer therapies.

“The only way to improve cancer treatment is to have clinical trials,” said Kyte.

Oslo Cancer Cluster also wants to bring more clinical trials to Norway to develop innovative cancer medicines. The ambition is to enable faster patient recruitment from across the Nordic region, so that many more can benefit from new treatments, such as immunotherapy.

 

CAR T cells are produced by isolating specific cells of the immune system (T cells) from a cancer patient and modifying them so that they become more effective at recognizing and killing cancer cells.

 

Promising advances

Immunotherapy represents a new type of cancer treatment, which activates the patient’s immune-system to fight off the cancer cells. It gives doctors the opportunity to help patients that previously had limited treatment options. Most types of immunotherapy also cause less side effects than traditional cancer treatments.

“The important point is that immunotherapy can have a long-term effect,” said Kyte.

“Most patients that experience a recurrence or progression of the disease cannot be cured. The traditional treatments only have a limited, short-term effect on them. But immunotherapy may have a long-term effect on the patient – and, in some cases, even cure the disease.”

 

Two big challenges

Immunotherapy may sound like a miracle drug, but researchers still have a long way to go to perfect the treatment for all cancer patients. Kyte highlights two of the biggest barriers that remain.

“One challenge is to develop immunotherapy so that it works efficiently on all types of cancer. The other challenge is to learn how to choose personalised treatment plans: to identify an individual’s biomarkers and find out which treatment will be effective for that specific patient.”

A biomarker is a biological molecule in the patient’s body and these may be used to see how well a patient will respond to a certain treatment. Kyte said that to develop immunotherapy, there needs to be more clinical trials. It is the only way for researchers to find out how to activate an immune response in the patient’s body.

“A big potential for development lies in trying different possible combinations of cancer treatments. In my clinical trials, for example, we combine immunotherapy with immunogenic chemotherapy or radiation therapy,” Kyte explained.

 

Jon Amund Kyte presenting the Clinical Trial Unit.

The Clinical Trial Unit are experts in assisting companies and researchers to conduct clinical trials in Norway.

 

Welcome, companies

OUH has a long history of conducting clinical trials and is an appealing option for both researchers, doctors and companies that wish to initiate their own trials. Kyte welcomes more companies to conduct clinical trials at OUH:

“The more clinical trials that are conducted here by companies, the stronger our clinical research environment becomes and our ability to run our own studies is also strengthened.”

The Clinical Trial Unit in Kyte’s department offers its services to companies that want to run a clinical trial at OUH. They have extensive background knowledge of how the hospital is organised and which approvals are needed to conduct a clinical trial in Norway. They can step in as project coordinator for companies that need help to get their clinical trials up and running.

“We are highly experienced in applying for approvals in Norway. When you run a clinical trial, there are regulations from the Norwegian Medicines Agency and the ethical committee and other governmental agencies. A clinical trial also involves many different parts of the hospital – the departments of pathology and radiology, the laboratories, the infusion unit, the hospital wards and out-patient clinic and the administrative offices that oversee different agreements, data management and biobanking.”

 

Nordic clinical trials

All these administrative obstacles may appear discouraging, but there are many convincing reasons to conduct a clinical trial in Norway.

“The Oslo University Hospital is a good place to run a clinical trial, because in terms of the number of cancer patients, it is one of the largest hospitals in Europe. Norwegian healthcare is also extremely well-organised. Patients are rarely lost to follow-up, because there are no private healthcare alternatives and patients rarely move out of the country,” Kyte explained.

The Clinical Trial Unit is also taking part in the development Nordic Nect, a collaboration to recruit patients from the entire Nordic region to clinical trials. The plan is to have one hospital where the clinical study is conducted and to involve patients from Sweden, Denmark, Finland and Norway. There will then be a population of 25 million people from which to recruit patients, which opens the possibility for larger clinical trials.

“This is a good thing for the companies that want to run clinical trials in Norway. It is also good for the researchers. But most of all, it is good for the patients – who have the opportunity to take part in more novel cancer treatments,” said Kyte.

 

 

 

 

Promising start for expansion group of Targovax clinical trial

Doctor examining the birthmark of a female patient

Targovax, one of the members of Oslo Cancer Cluster, has begun an expansion patient group in the clinical trial of a drug to treat skin cancer.

The company Targovax is developing immune activators to target solid tumours that are difficult to treat. The drug in question, called ONCOS-102, is aimed at patients with malignant melanoma (skin cancer) who have either been through chemotherapy, biological therapy or surgery and experienced a recurrence or progression of the cancer.

 

How does it work?

The immune activators work by activating the patient’s own immune system to attack the cancer cells. The drug that is now being tested is a genetically modified oncolytic adenovirus, a type of virus that has been designed to infect in the cancer cells and then replicate.

 

Initial positive results

Targovax, a member of the Oslo Cancer Cluster, are developing a treatment for skin cancer.

In September 2018, the first six patients had been treated with 3 injections of the drug and all of them showed a strong activation of their immune systems – one patient even had a complete response. The results suggested that the patients could benefit from more injections of the drug.

“The results seen to date with only three injections of ONCOS-102 are promising, and we are confident that by increasing to twelve injections we will release the full potential of ONCOS-102 to reactivate these patients to respond to Keytruda treatment,” said Magnus Jäderberg, CMO of Targovax.

 

Expansion patient group

On 11 February 2019, the first patient in the expansion group of the phase I trial was injected with ONCOS-102. The patient will be treated in combination with pembrolizumab, also known as Keytruda, an immunotherapy drug that works as an immune checkpoint inhibitor. This means that the drug involves antibodies, which “unlock” the protective mechanisms of the cancer cells so the immune system then can destroy them.

 

For more information, read the full press release from Targovax.