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.

 

The pupils Kalina Topalova Casadiego, Ida Hustad Andresen,Andreas Bernhus and Dina Düring had the opportunity to experiment with fruit flies at the Institute for Cancer Research in Oslo.

Operation fruit flies

Three students experimenting with fruit flies in a lab.

Fruit flies are not only annoying little insects that appear when bananas are overripe. They are also popular research tools for cancer researchers.

The four pupils Kalina Topalova Casadiego, Ida Hustad Andresen, Andreas Bernhus and Dina Düring got to experience how cancer researchers look at fruit flies during their work placement in January.

“Let’s turn on the gas, and then I’ll put some fruit flies on the pad under your microscope.” Speaking is cancer researcher Lene Malrød who, together with her colleague Nina Marie Pedersen, is responsible for four pupils from Ullern Secondary School on work placements.

“Gosh! They’re moving,” proclaims one of the pupils.

But not for long. Soon, all the fruit flies are anaesthetised and, eventually, dead; then the pupils are tasked with surgically removing the ovaries of the female flies. It is easier said than done, even with the help of microscopes to enhance the tiny flies. Especially when the operating tools are two tweezers.

Fruit flies are kept in two test tubes

The fruit flies are kept in test tubes.

 

An exciting placement

It is the third day of the pupils’ work placement at the Institute for Cancer Research, located next to the school. For four days at the end of January, they have learnt about cancer research and which methods researchers use in their daily work.

“The work placement is not like we imagined,” says Kalina and Ida.

“There’s a lot more manual work than I would have thought, and then you realise how important research is through what we do,” says Ida.

She is the only one who is specialising in biology in combination with with other science subjects, and she finds this very useful when working in the lab together with researchers. The other three have had to catch up on the reading, but they all agree that it is very exciting.

“Yesterday, we learnt a lot about CRISPR, which is a new method for cutting and splicing genes. Media gives you the impression that this is a highly precise tool, but the researchers here say that a lot can go wrong, and that it’s not at all as precise as you might think,” says Ida.

A student looks at fruit flies under a microscope

The students look at the fruit flies under a microscope.

 

From Western Blot to flies

A total of twelve pupils were picked out for this work placement. They have been chosen based on motivation and grades, and they all have a wish to study something related to medicine or science after they finish upper secondary school.

The twelve students are divided into three groups with completely different activities and get to learn a number of different research methods. The group consisting of Ida, Kalina, Andreas, and Dina, for instance, is the only group which will have a go in the fly lab.

“Am I really supposed to remove the ovaries? I don’t see how,” one of the pupils say, equally discouraged and excited.

Andreas, on the other hand, is in complete control. First, he has separated the males and the females with a paint brush. He has then used the tweezers to remove the heads from the females, punctured the bottom to remove the intestines, and finally found the ovaries in the abdomen.

Lene gathers all the different body parts for the pupils to look at through a different microscope. These fruit flies are in fact genetically manipulated to glow in the dark – they are fluorescent.

If you are wondering why researchers use fruit flies as part of their research, you can read more about it in this article from Forskning.no (the article is written in Norwegian).

“It is so much fun to be here, and we are really lucky to get this opportunity,” says Dina on her way from the fly lab to another lab to carry out another experiment.

 

The pupils on the work placement have uploaded many nice photos and videos on Ullern Secondary School’s Instagram account – visit their account to see more from the placement.