Meet our new members

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Oslo Cancer Cluster proudly presents the new members that have joined our organisation during the first quarter of 2019.

 

The new members represent a valuable addition to our non-profit member organisation, which encompasses the whole oncology value chain. By being a part of Oslo Cancer Cluster, our members are connected to a global network with many relevant key players in the cancer research field. Our members contribute to this unique ecosystem and ensure the development of innovative cancer treatments to improve patients’ lives.

 

HalioDx

HalioDx is an immuno-oncology diagnostic company providing immune-based services, which guide cancer care and contribute to precision medicine. HalioDx executes biomarker studies and develop diagnostic devices, in accordance with regulations and in partnership with biopharmaceutical companies. By being a member of Oslo Cancer Cluster, HalioDx can collaborate with academia and industry to deliver clinical research and diagnostic tools that help find the right therapy for the right patient.

“Immuno-oncology and precision medicine are two main focuses of interest for Oslo Cancer Cluster and this is the reason why HalioDx decided to become a part of Oslo Cancer Cluster.” 

“We are convinced that this collaboration will be of mutual benefit and we hope that HalioDx’s comprehensive clinical research platform will represent a great tool for the academic and pharma members who would like to better understand drugs mechanisms of action and identify the right patients for the right therapy.”
Aurélie Fugon, Associate Director, HalioDx

 

 

 

MultiplexDX

MultiplexDX is a biotech corporation with the aim to eliminate misdiagnosis of cancer disease. The company’s idea is to create 100% reliable, quantitative, affordable and personalised diagnostic tests. By combining tissue visualisation and sequencing technologies, they can accurately quantify 7 or more cancer markers, generating a specific “barcode”. This unique barcode can then specify the type of cancer and suggests which personalised treatment and medicines to be used, and how long the therapy should last.

“We believe that Oslo Cancer Cluster is the best cancer cluster in the world representing the entire oncology value chain that we want to be part of.” Pavol Cekan, CEO, MultiplexDX

“We plan to create strategic partnerships with Oslo Cancer Cluster members to bring our breast cancer diagnostic test, Multiplex9+, to the market as soon as possible. In assistance with Oslo Cancer Cluster and its members, we want the breast cancer patients to benefit from our 100% accurate, reliable and diagnostic test at the earliest convenience.” 

 

Sanofi (Norway)

Sanofi is a global pharmaceutical company and one of their main areas of treatment concerns oncology. Every year, they invest 15% of their revenue into research and development. They do phase I, II and III clinical trials to get new medicines approved for treatment. They want to remain innovative, because they believe that the research they perform today will contribute to preventing and treating diseases in the future.

“Sanofi has a long legacy with R&D in oncology. In the years to come oncology and hematology will be one of the biggest therapeutic areas at Sanofi.

“By becoming a member of Oslo Cancer Cluster we believe that we are able to contribute to unlocking tomorrow’s science by supporting the latest advances in treating cancer in Norway and beyond.” Britt Moe, General Manager, Sanofi (Norway)

“This is especially interesting since in the treatment of cancer, new mechanisms of actions and developments, such as immune-oncology therapies, are very much in the focus.” 


Thommessen

Established in 1856, Thommessen is a leading commercial law firm with offices in Oslo, Bergen, Stavanger and London. The firm provides advice to Norwegian and international companies as well as organisations in the public and private sectors, ranging from start-ups, via small and medium size companies to large multi-national corporations. Thommessen covers all business related fields of law.

“We believe that early identification of potential legal issues before they arise is important.” Mirella Gullaksen, Head of Projects and Business Development, Thommessen

“Investing in early phase biotech/oncology companies should be about the relevant team, technology and product breakthrough. All other risks relating to the company, and investments should be reduced to a minimum”. 

 

  • This post is the first in a series of articles, which will introduce the new members of our organisation every three months.
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  • To find out who else is involved in Oslo Cancer Cluster, view the full list of members.

 

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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

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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.

 

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

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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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The panel discussion at our breakfast meeting 27 March 2019. From the left: Jan Frich, Anette Grøvan, Odd Terje Brustugun, Heidi Brorson, Tove Nakken and Markus Moe.

Giving patients a stronger voice

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How can the voices of cancer patients be heard when evaluating new methods of treatment?

A breakfast seminar was held yesterday in the series called The Cancer Treatments of the Future. Over 150 people attended at Litteraturhuset in Oslo, among them were relevant key players from the healthcare sector, governmental agencies, patient organisations and the public. The aim was to identify new opportunities to improve patient involvement when evaluating new methods of treatment.

The seminar was jointly arranged by Oslo Cancer Cluster, Legemiddelindustrin (LMI) and The Norwegian Cancer Society. The sponsors of the event were Astra Zeneca, Janssen and MSD.

 

Anne Grethe Erlandsen

Anne Grethe Erlandsen, the State Secretary of the Norwegian Ministry of Health and Care Services.

Anne Grethe Erlandsen, the State Secretary of the Norwegian Ministry of Health and Care Services, first talked about creating a healthcare service with the patient as the starting point. She said that it is important to involve the patient in the decision-making processes to bring in new perspectives, ask questions and challenge the healthcare service.

“The patient is the most radical agent of change in the healthcare sector.”
Anne Grethe Erlandsen

 

Ellen Nilsen

Ellen Nilsen, Special Adviser at Nye Metoder.

Next, Ellen Nilsen, Special Adviser at Nye Metoder, which is the national system for managed introduction of new health technologies within the specialist health service in Norway. Nilsen gave a presentation of Nye Metoder and its processes.

 “Anyone, including patients, their relatives or patient organisations, can submit a proposal for a new method of treatment.” Ellen Nilsen

The proposal is then managed by the regional health authorities in The Commissioning Forum, which commissions a full Health Technology Assessment (HTA) from The Norwegian Medicines Agency. Anyone can submit input to The Commissioning Forum by e-mail or in a form on the website.

Decisions are then made by the regional health authorities in The Decision Forum, based upon the HTA. Patient organisations are also represented in a reference group that meets every six months. The patient representatives are only observers, but have the right to make verbal contributions.

  • Learn more about Nye Metoder by reading this presentation in English from their official website.

 

Health Technology Assessment (HTA) is the evaluation of a new method of treatment, often in comparison to existing treatments. The treatments are assessed according to a set of criteria: the severity of the disease, the utility of the treatment and its cost effectiveness.

 

Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency.

Then, Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency, presented how they are developing a pilot project to involve patients in their HTAs. They have sporadically received input from patients and patient organisations in the past, but they wish to implement a better system for it now.

“Satisfied patients are important to us. Everyone should have a voice, regardless of their diagnosis or disease.” Anette Grøvan

They believe the patients can contribute with their experiences of living with the disease, the quality of existing treatments and their expectations on new treatments.

 

 

A panel discussion, moderated by Markus Moe, the Editor-in-Chief of Dagens Medisin, was then held with the following participants:

  • Tove Nakken, Head of brukerutvalget* at Oslo University Hospital and Deputy Head in Lymfekreftforeningen (The Norwegian Lymphoma Society)
  • Heidi Brorson, member of brukerutvalget* at the South-Eastern Norway Regional Health Authority and Special Adviser in the Norwegian Cancer Society
  • Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency
  • Jan Frich, Chief Medical Officer at the South-Eastern Norway Regional Health Authority and Senior Adviser in the Commissioning Forum
  • Odd Terje Brustugun, oncologist at Drammen Hospital

*”brukerutvalget” is a selected group of patient representatives that exists in each regional health authority

 

The topic of the panel discussion was how to improve patient involvement when evaluating and approving new methods of treatment.

 

Nakken first highlighted the lengthy processes in Norway: “Patients want to take part of the treatments that have been approved in our neighbouring countries. But the bureaucracy in Norway takes too long.”

Brustugun agreed that there is a gap between the treatments available in Norway and abroad, and that this is affecting an ever-growing patient population: “The patient’s perspective is important, because there is a large group of patients that can potentially become long-term survivors if given the new treatments.”

Frich said the overall cost of pharmaceuticals in Norway has actually increased over the years, mostly due to new and expensive cancer therapies. He explained they are legally obliged by Stortinget to evaluate new methods according to a specific set of criteria. The reason that a treatment isn’t approved may be that the effect of it has not been documented well enough.

Brorson called for greater transparency in the decision-making processes: “If there was more openness about the decision-making, the patients would have a greater understanding for it and become better informed.”

Grøvan added: “We are not finished developing the system for patient involvement and there are a lot of considerations to make sure that it becomes structured and fair.”

 

The engaging panel discussion inspired the audience to make their own comments and reflections.

 

The fruitful discussion led to many constructive ideas on how to improve patient involvement. Hopefully, these kinds of collaborative discussions can inform politicians to take the necessary steps forward to improve cancer patients’ lives.

Oslo Cancer Cluster wants to thank the speakers, the sponsors, the organisers and everyone who attended! This discussion will continue at Arendalsuken 2019, at our event August 15. We hope to see you there!

 

  • Here is a summary of the event, written in Norwegian, from LMI’s official website.