Number of applications for clinical trials in Norway 2013-2023. Source: The Directorate for Clinical Products.

Advancing Cancer Research in Norway: Eli Lilly’s SUNRAY-01 Study

/in , , , /by

Eli Lilly selected Norway as the site for its groundbreaking study project, SUNRAY-01, despite the recent year’s decline in applications for clinical cancer trials.

This study examines the efficacy of the drug candidate LY3537982 on advanced non-small cell lung cancer (NSCLC) with a specific genetic alteration. and represents a significant advancement in health research and treatment for patients with KRAS G12C mutations, potentially reshaping the treatment landscape for this specific patient group.

The KRAS G12C mutation is a specific alteration in the KRAS gene, often associated with certain cancers such as non-small cell lung cancer. This mutation plays a significant role in promoting the growth and spread of cancer cells. Researchers are exploring methods to block or inhibit the effects of this mutation.

Decline in trails

Recently, Norway has experienced a notable decline in the number of applications for cancer clinical trials, dropping from 158 in 2022 to 98 in 2023. Lars Petter Strand, Senior Medical Director for the Nordics at Eli Lilly, voiced concern, noting,

Lars Petter Strand. Photo Eli Lilly

“We observe that the number of cancer clinical trials in Norway has significantly decreased.” He highlighted the global trend of increasing clinical trials in countries like the USA and China, contrasting with the reductions in most European countries.

Norway’s participation in Eli Lilly’s SUNRAY-01 study indicates a positive shift. Lars Petter Strand attributed the decision to several favourable trends in Norway’s healthcare system, including initiatives like CONNECT, IMPRESS, InPRED, and NorTrials, which have enhanced infrastructure and processes, making Norway an appealing destination for clinical trials.

Positive outlook for patients

Bjørn Henning Grønberg, Head of Department for Translational Cancer Research at St. Olav Hospital, one of the 7 hospitals selected for this study, emphasized the importance of such studies, stating, “It is always welcome to offer study participation to our patients.” The proportion of lung cancer patients with KRAS mutations eligible for targeted treatment through this study exceeds those eligible for other targeted treatments.

One of the most exciting and significant aspects of this study is its focus on finding targeted treatments for KRAS mutations, which currently aren’t as effective as other options available.

Patients with this mutation respond to immunotherapy, unlike those with EGFR and ALK positives, making it an interesting combination to explore. However, in the past, this has been challenging, as the combination of KRAS inhibitors with immunotherapy was too toxic, says Grønberg.

Challenges and opportunities

Despite these positive developments, Norway encounters challenges in maintaining its attractiveness for clinical trials. Strand emphasized the importance of addressing barriers such as delayed introduction of new treatments, lengthy approval processes, and capacity constraints in diagnostic tools at hospitals.

The roadmap for the health sector, a strategic document guiding sector development, underscores the significance of clinical trials in health research. While the government has set ambitious goals for increasing clinical trials, collaboration across sectors and collective efforts are essential to address challenges hindering this vital part of medical research.

A roadmap for the health industry

Oslo Cancer Cluster General Manager Ketil Widerberg emphasizes that this new study aligns well with the Norwegian government’s aspirations for a national health industry and ongoing efforts at Oslo Cancer Cluster to foster innovation and collaboration within the cancer research field. It represents a crucial step towards advancing cancer care and supporting Norway’s health industry growth.

Widerberg stresses the importance of patients accessing the latest treatment, doctors and researchers gaining insights into the latest technology, and the development of the Norwegian health industry, as Norwegian centres of expertise gain international visibility.

Crucial collaborations

To attract more clinical trials to Norway, stakeholders must collaborate effectively, as Lars Petter Strand highlights. It requires creating sufficient resources in hospitals, facilitating efficient communication between the pharmaceutical industry and healthcare institutions, and streamlining startup processes. Improved communication between the pharmaceutical industry and hospitals is essential, as demonstrated by Eli Lilly’s collaboration with NorTrials during site recruitment for this study.

Collaboration between industry players, research institutions, and government bodies is crucial for advancing cancer research. Initiatives like NorTrials facilitate this collaboration, ensuring nationwide access to cutting-edge treatments, says Strand

The post Advancing Cancer Research in Norway: Eli Lilly’s SUNRAY-01 Study first appeared on Oslo Cancer Cluster.

Photo: Christopher Olssøn/Oslo Cancer Cluster

News from our members

/in , , , , , , /by

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

 

Sign up to our monthly newsletter

Torbjørn Furuseth, Chief Financial Officer, Targovax, is delighted to announce that the company's second part of the clinical trial for skin cancer patients will be held at Oslo University Hospital.

New clinical trial at Oslo University Hospital

/in , , , , , , /by

Torbjörn Furuseth, Targovax

Our member Targovax has announced a new clinical trial for skin cancer patients at Oslo University Hospital.

The second part of a clinical trial for patients with refractory advanced melanoma (a type of skin cancer) will take place at Oslo University Hospital.

“We are excited that we can offer this treatment alternative to patients in our home country, and hopefully it will help us to recruit more patients faster,” said Torbjørn Furuseth, Chief Financial Officer, Targovax.

Targovax is a Norwegian biotech company that develops oncolytic viruses called ONCOS-102 to destroy cancer cells. The treatment is targeted towards solid tumours that are especially hard to treat. The ultimate goal is to activate the patient’s immune system to fight cancer.

Promising results

“The trial is until now conducted at three top hospitals in the US, where competition for patients to clinical trials is high. Oslo University Hospital is also a great cancer center, and currently there are no trials offered to this patient population,” said Furuseth.

Three out of nine patients responded to the treatment during the first part of the clinical trial. This included one complete response and two partial responses.

Dr. Magnus Jäderberg, CMO of Targovax, said: “It is promising to see this level of clinical responses after only three ONCOS-102 injections, including a complete response, which is rare in this heavily pre-treated patient population.”

A forceful combination

The treatment involves a combination of an oncolytic virus and an anti-PD1 checkpoint inhibitor.

The oncolytic virus is a modified virus that has been developed to selectively attack and kill cancer cells. You can read more about the oncolytic viruses on Targovax’s official website.

The anti-PD1 checkpoint inhibitor disrupts the interaction between proteins on the surface of cancer cells. This stops the cancer from evading the immune system.

“Earlier this year, we decided to expand the trial to test a more intensified schedule of ONCOS-102, and it will be interesting to see whether this regimen can generate more and deeper clinical responses,” said Dr. Alexander Shoushtari, Principal Investigator, Memorial Sloan Kettering Cancer Centre, New York.

The second part of the clinical trial is currently enrolling new patients.

 

Sign up to OCC newsletter

A new drug combination from Vaccibody and Roche may help to treat patients with cervical cancer.

New collaboration aims to treat cervical cancer

/in , , , , , , , , /by

Hands cradling female reproductive system

The companies Vaccibody and Roche have started a new collaboration to investigate a drug combination to treat patients with advanced cervical cancer.

Both companies are members of Oslo Cancer Cluster and are involved in the development of novel cancer treatments.

Martin Bonde, CEO of Vaccibody, said: “We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with advanced cervical cancer.”

Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide.

Vaccibody is a vaccine company that aims to develop and discover new immunotherapies to treat difficult forms of cancer. They have developed a therapeutic DNA vaccine that treats cancers caused by HPV (the human papillomavirus).

Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer.

Immunotherapy is a type of cancer treatment that aims to switch on a patient’s immune system to kill cancer cells.

Roche is a healthcare company that has developed an immune-checkpoint inhibitor. Now Vaccibody wants to test their vaccine in combination with the immune-checkpoint inhibitor designed by Roche.

An immune checkpoint inhibitor is a type of drug that blocks certain proteins made by some types of cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells better.

Agnete Fredriksen, President and CSO of Vaccibody, said that the combination of the two drugs build on the positive results seen when their vaccine has been used on patients with cervical cancer. Therefore they now expect to see positive results when they combine the vaccine with an immune checkpoint inhibitor.

During the second half of 2019, Vaccibody expects to begin the phase II study, which will involve 50 patients. It will assess the safety of the drug, its ability to invoke a response in the immune system, how the patients tolerate it and how efficient the drug is. The group for this new drug combination involves patients with advanced cervical cancer.

 

Raised NOK 230 million

Vaccibody also raised NOK 230 million (EUR 23.6 Million) in a private placement the same week. The sum was indeed placed all within one day, according to Agnete Fredriksen.

The proceeds from the share sales will be used to conduct the phase II clinical study of the drug combination from Vaccibody and Roche. The money will also go to the preparation of expansion patient groups in Vaccibody’s clinical trials and to generate corporate purposes.

 

For more information, read the press release from Vaccibody.