Reports from the third quarter from our members have been published. Photo: Unsplash

What’s new in Q3?

Two persons working in front a two laptops.

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

BerGenBio logo

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 logo

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 logo

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 logo

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 logo

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.

 

Jeg vil gjerne legge lista høyt og foreslå en felles database for data fra kliniske studier, hvor både firmaer og myndigheter har tilgang til helsedata umiddelbart etter at hver pasient har fått sin behandling, skriver Ketil Widerberg.

Hvordan gjør vi våre mest intime data til gull?

Ketil Widerberg, general manager, OCC

The following opinion piece was written by Ketil Widerberg, General Manager at Oslo Cancer Cluster, and published in Aftenposten on 1 May 2019. It is a response to an opinion piece written by Nikolai Astrup, the Norwegian Minister of Digitalization, which was published on 22 April 2019. The texts are only available in Norwegian, but a short summary in English is available at the bottom of this page.

 

Helsedata er en voksende gullåre, men vi kan ikke grave i den uten videre.

 

I Aftenposten 17. april svarer digitaliseringsminister Nikolai Astrup (H) på en appell om våre verdifulle data.

Astrup påpeker at data ikke kan sammenlignes med olje, for det er ikke staten, men hver og en av oss, som eier våre egne personopplysninger.

Det gjelder i høyeste grad de mest intime av våre data: helsedata.

 

En gullåre av data

Helsedata er en voksende gullåre, men vi kan ikke grave i den uten videre.

Hadde vi ikke først bygd opp beskyttelse av norske data og kompetanse, ville ikke prosjekter som DoMore blitt til.

Forskerne i DoMore bruker avansert bildeanalyse for å gi mer presise kreftprognoser. Samtidig ville ikke prosjektet eksistert uten internasjonale data og kompetanse.

For næringen som jeg jobber i, helsenæringen, er spørsmålet hvordan vi skal unngå å falle i digitaliseringsfellen. Der har mediebransjen landet.

Facebook og Google får all verdens data gratis gjennom samtykke og tar dermed livsgrunnlaget fra tradisjonelle aktører.

 

Trenger god strategi for kunstig intelligens

For norsk helsenæring blir de to strategiene som digitaliseringsministeren snart lanserer, digitalisering i offentlig sektor og kunstig intelligens, svært viktige. I en strategi for offentlige data oppfordrer jeg derfor til at fremskritt innen presisjonsmedisin tas med.

Da Kreftregisteret ble etablert på 50-tallet, forsto ingen den fulle nytteverdien av et slikt register. I dag tiltrekkes forskere og bedrifter fra hele verden for å få bruke data derfra.

Det viser hvorfor vi også i dag bør samle inn mer helsedata enn vi kan dra nytte av umiddelbart.

Hvordan finner vi balansen mellom god bruk av helsedata for å skape næring og rå utnyttelse av store firmaer? Her trenger vi en god strategi også for kunstig intelligens, som tar inn over seg denne balansegangen i helsedata.

Kunstig intelligens gjør presisjonsmedisin mulig på et helt annet nivå enn vi er på i dag, med mye høyere presisjon i behandlingen.

 

Ressurs for pasienter

For fremtidens presisjonsbehandling er helsedata ressursen vi må samle på. Vi må samle inn helsedata som gjør behandlingen bedre for neste pasient. Og vi trenger en struktur av dataene der både firmaer og myndigheter har tilgang til dem.

Jeg vil gjerne legge lista høyt og foreslå en felles database for data fra kliniske studier, hvor både firmaer og myndigheter har tilgang til helsedata umiddelbart etter at hver pasient har fått sin behandling.

Dette kan bidra til raskere tilgang til ny behandling og bedre oppfølging av pasienter med sykdommer som kreft.

Data former kreftbehandling og skaper nye tilbud til pasienter. Hvordan sikrer vi verdien av dataene? Skal vi gi dem bort for å bygge forskning og industri, skal vi ta så mye penger som vi kan for dem, eller skal vi prøve å finne på noe midt imellom?

I arbeidet med de nye strategiene bør våre mest intime data bli diskutert – med sikte på å skape verdi og næring av dem.

 

 

Short summary in English:

The question Astrup raised in his opinion piece concerned how data sharing can be improved across the public sector in Norway.

Widerberg responds by highlighting how we can make use of our health data to create added value and a successful health industry, without allowing large multinational corporations exploit the data freely.

Artificial intelligence makes precision medicine possible on a much higher level than today. We need to collect health data in order to improve treatments for future patients.

Widerberg therefore proposes a database where health data from all clinical trials is made available to both private and public bodies. This would contribute to making better treatments available sooner and provide better follow-up to patients suffering from diseases, such as cancer.

 

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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.

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

New collaboration aims to treat cervical cancer

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.