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What’s new in Q3?

Positive results from clinical trials, revenue growth and new clinical collaborations … Read some of the third quarter developments from our members below.

BerGenBio

  • BerGenBio showed results from their clinical trial for patients with non-small cell lung cancer, who have previously been treated with chemotherapy. The results showed they met primary and secondary endpoints.
  • The company presented interim safety data from a Phase Ib/II trial. They are testing their drug bemcentinib in combination with pembrolizumab on melanoma patients. The data shows the combination is well tolerated by patients.
  • The U.S. Food and Drug Administration (FDA) has granted bemcentinib Fast Track Designation. This means they will do an expedited review of the investigational drug. The designation is for the treatment of elderly patients with acute myeloid leukemia (AML), who have relapsed.

Read more in the press release from BerGenBio

Nordic Nanovector

  • Nordic Nanovector raised approximately NOK 243 million in private placement of new shares. This will provide further funds to continue the clinical development of their drug Betalutin, manufacturing and other commercial activities.
  • The company presented new results from a clinical trial, testing their drug Betalutin on patients with non-Hodgkins lymphoma (a type of blood cancer). The median duration of response was 13.6 months for all responders and 32.0 months for complete responders.
  • The company reported 3 out of 3 patient responses in the first patient cohort in one of their clinical trials. The patients were given Betalutin in combination with rituximab to treat 3rd-line relapsed or refractory follicular lymphoma (also a type of blood cancer).

Read more in the press release from Nordic Nanovector

Photocure

  • Photocure reported a revenue growth of 42% in local currency for the US market.
  • The revenues in the Nordics declined 7% to NOK 9.9 million (NOK 10.6 million) in the third quarter.
  • The company entered into a licensing agreement with Asieris Meditech Co. to commercialize the product Cevira to the global market. Cevira is a non-invasive photodynamic therapy for HPV-related (cervical) diseases.

Read more in the press release from Photocure

 

Targovax

  • Targovax presented new data from the first part of the clinical trial of their oncolytic virus. The trial has shown clinical responses in three out of nine patients. This treatment targets patients with refractory advanced melanoma (skin cancer).
  • The company announced an expansion of the clinical trial of the oncolytic virus ONCOS-102 in combination with the checkpoint inhibitor Imfinzi. This trial is open for patients with advanced peritoneal malignancies (a rare cancer that develops in the tissue that lines the abdomen).
  • The company publicised that Oslo University Hospital will become a site for the clinical trial of their oncolytic virus ONCOS-102.

Read more in the press release from Targovax

 

Ultimovacs

  • Ultimovacs presented long-term results from the clinical study of their therapeutic cancer vaccine UV1. The patients have non-small cell lung cancer and the trial has shown a 4-year overall survival rate of 39% (7 of 18 patients are still alive).
  • New data from their prostate cancer trial showed a 5-year overall survival rate of 50% (11 of 22 patients are still alive).
  • A phase II clinical trial for patients with malignant melanoma (skin cancer) is projected to start in the first quarter of 2020.

Read more in the press release from Ultimovacs

 

More third quarter reports from our other members are or will be made available on their respective websites.

 

The students in the picture are Jacques Li, a doctor and entrepreneur from France; Diana Murguia Barrios, an economist and political scientist from Spain; Jason Yip, a chemistry engineer from England; and Sam Chong, a lawyer and economist from Malaysia and Australia.

Should Norway implement a clinical trial league table?

We asked four MBA students from Cambridge University to evaluate how patient recruitment practices in Norway can be improved.

The number of clinical trials in Norway has been declining over the last few years. There are many reasons behind this trend, but until now there have been few concrete solutions. With the number of cancer patients on the rise, there is a growing need for access to better treatments.

Oslo Cancer Cluster asked four students from Judge Business School at Cambridge University to research how the number of clinical trials in Norway can be improved. The students were Jacques Li, a doctor and entrepreneur from France; Diana Murguia Barrios, an economist and political scientist from Spain; Jason Yip, a chemistry engineer from England; and Sam Chong, a lawyer and economist from Malaysia and Australia.

“The number of clinical trials in Norway is less than half of the number in Denmark.”

The group focused on one of three factors that influence the number of clinical trials in Norway, namely: the patient recruitment practices. After a comparative analysis with other European countries, they came up with two main recommendations on how Norway can improve patient recruitment.

 

Image och doctors and nurses walking in corridor

How do we motivate hospitals and doctors to recruit more patients to clinical trials?

 

One: Motivating hospitals

The group compared patient recruitment in Norway to France, United Kingdom and USA. Norway was the only country where hospitals don’t have any non-financial incentives to recruit patients to clinical trials. If a hospital’s reputation could be improved in a concrete way by having clinical trials, patient recruitment could also be improved.

The group proposed to create a league table for all hospitals, with cancer trial participation as one of the metrics. This would create competition between hospitals, encourage collaboration between smaller hospitals and larger ones, and make information about clinical trials accessible to patients.

If hospitals were ranked against each other based on clinical trial output, they would more actively recruit into trials due to the reputational incentive.” 

The group also uncovered a misalignment between the funding source and the implementers of the clinical trials. Funding is passed from the Norwegian Health Ministry to the regional health authorities, instead of directly to the hospitals who conduct the trials. The group recommended that the hospitals need direct financial incentives to conduct the trials.

“Regional health authorities in Norway need to ensure that funding provided to them for research is passed down to the hospitals conducting clinical trials.” 

 

How do we raise awareness among patients and doctors about clinical trial participation?

 

Two: Raising awareness

A second discovery in the report was the lack of awareness about clinical trials among both patients and doctors. Patients in Norway lack access to relevant information that would empower them to opt into clinical trials. There was similarly a lack of exposure to clinical trials among early career doctors and a lack of initiatives to collaborate on clinical trials among advanced career doctors.

“Raising awareness among stakeholders is key to improve clinical trial recruitment.” 

The students suggested working in partnership with patient organisations to raise awareness among patients. They recommended a national awareness campaign to inform where patients can find up-to-date information about clinical trials. All hospitals could keep lists of their ongoing clinical trials available on their websites.

If patients knew the benefits of clinical research, they would select a hospital that is ranked highly.” 

The group also provided recommendations to raise awareness among doctors to work on clinical trials. Rotational programs and supplementary courses on research methods and clinical trials may spark interest among medical students to pursue work in clinical trials. Seminars and workshops can help to both raise awareness and inspire collaborative efforts among doctors in their advanced careers.

 

Oslo Cancer Cluster wishes to extend a big thank you to everyone who agreed to be interviewed for this research project:

  • Ali Areffard, Medical team, Bristol Myers Squibb
  • Øyvind Arnesen, Chairman of the Board, Oslo Cancer Cluster
  • Siri Kolle, Vice President Clinical, Inven2
  • Jónas Einarsson, former Chairman of the Board of Oslo Cancer Cluster and one of the founders of Oslo Cancer Cluster Innovation Park
  • Maiken Engelstad, Deputy Director, Ministry of Health and Care Services
  • Katrine Bryne, Senior Advisor, Legemiddelindustrien (LMI)
  • Kristin Bjordal, Business Manager for Research Support and Research Manager in Oslo Hospital Service (OSS) and Chairman of the Board of NorCrin
  • Ida Kommandtvoll, Advisor, Department of Strategy and Analysis, The Norwegian Cancer Society
  • Knut Martin Torgersen and medical team, Merck
  • Steinar Aamdal, the founder of The Clinical Trial Department, Oslo University Hospital

 

View and download the following PDF of the Cambridge report to learn more.
Note: This is a short version of the report, the fuller version also includes an Appendix containing detailed information about all the underlying data and interview material. Please get in touch with Communications Adviser Sofia Lindén if you are interested in reading the full Appendix.

Download [1.27 MB]

 

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Doctor examining the birthmark of a female patient

Promising start for expansion group of Targovax clinical trial

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.

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.