At Oncoinvent’s lab. Photo: Oncoinvent.

Inven2 manages agreements for clinical studies on behalf of the Cancer Clinic at Oslo University Hospital that conduct studies for many Norwegian companies that develop cancer treatments. “This is an important contribution to the Norwegian health industry and shows that we are competing internationally,” said Siri Kolle, VP Clinical Trials at Inven2.

OncoInvent is one of the promising Norwegian cancer companies that run clinical studies at the Norwegian Radium Hospital, a part of Oslo University Hospital. They initiated two phase I studies in May and June this year, on ovarian and colorectal cancer with progression to the abdominal cavity.

The disease progression to the abdominal cavity is what often kills the patients and there is no effective treatment today.

­­“The product we have in clinical development is called Radspherin®. Radspherin® is a radiopharmaceutical product. It emits alpha rays that effectively kill cancer cells and are gentle for the patient, since the radiation only reaches a diameter of a couple of cells,” said Hélen Johansen Blanco.

Blanco is Head of Clinical Operations at OncoInvent and is responsible for the company’s clinical studies. She has more than 20 years of experience with clinical studies from both big pharmaceutical companies like AstraZeneca and Celgene, and several biotech companies.

OncoInvent is the third of the four companies that serial entrepreneurs Roy Larsen and Øyvind Bruland have initiated. Algeta was the very first one and was sold to the global biopharmaceutical company Bayer in 2013 for the impressive sum of NOK 18 billion.

Read more about OncoInvent in the fact box at the bottom of this article.

CLOSE PRIVATE-PUBLIC COLLABORATION

The overview from Inven2 shows that eight of the Norwegian companies developing cancer treatments run clinical studies at Oslo University Hospital at the moment.

These are Targovax, PCI Biotech, Nordic Nanovector, Ultimovacs, Vaccibody, OncoInvent, BerGenBio and Exact Therapeutics.

What the companies have in common is that they are based on cancer research from Norway, either from academic institutions like a university or hospital, or they have been spun out of private companies.

“Oslo University Hospital has the expertise and feasibility to perform these types of complex early phase studies and is competitive internationally. This is an important prerequisite for Norwegian start-ups to be able to test their treatments in Norway,” said Siri Kolle, VP Clinical Trials at Inven2.

Being able to conduct clinical trials locally are an important part of the building of a well-functioning ecosystem for the health industry in Norway.

“This also means that Norwegian cancer patients gain access to new and innovative treatments from Norwegian biotech companies long before the treatments reach the market,” said Kolle.

In addition, some of these companies and other Norwegian pre-clinical stage companies buy other services from Oslo University Hospital.

“These services are important for the companies’ research and development, both in pre-clinical and clinical stage. The services include, among other things, pre-clinical studies, production, analysis and reports,” said Kolle.

NORWAY NEEDS TO COMPETE

The fact that OncoInvent can perform studies in Norway is important for the company. However, it is not a default desision. The biotech company is “born global” and the studies they run in Norway need to be on the same level, or better, than the clinical studies they run abroad.

“The aspects being particularly important for us when we choose which locations to place our clinical studies are: the quality of the clinical data, the implementation of the study, that the study is started quickly and that the clinical site can recruit the number of patients they have promised,” said Blanco.

She is very pleased with the two clinical studies that Oncoinvent have ongoing at Oslo University Hospital so far and is happy to place more studies there if this positive experience lasts.

“One of the studies we have on colorectal cancer with progression is at the national centre responsible for treating patients with colorectal cancer that has spread to the abdominal cavity. This is a site with high recruitment of patients from the entire country and they perform the study at a high level. They have included four patients so far and the first dose level is confirmed as being safe for the patients. No patients have dropped out of the study after signing the consent forms,” says Blanco.

The last part is an important point. Blanco tells us that they thought some patients would drop out of the study after giving their consent. This is due to very specific inclusion criteria in all clinical studies, but the patient must first give consent before any testing can be done.

This shows that the site, led by gastro surgeon Stein Larsen, knows the patient group very well, Blanco points out.

“In addition, to have a quick start up the agreement process is essential. The negotiation process with Oslo University Hospital has been relatively quick and simple,” said Blanco.

She still points out that there are some structural challenges when initiating studies in Norway, such as the lengthy application processes at the Norwegian Regulatory Authority and the Regional Ethics Committee, compared to other countries like Singapore and USA. OncoInvent’s experience is that Norway has been the quickest country to start up studies in so far.

“Compared to my experiences from the global studies I have managed, Norway has traditionally been a high cost country and then we expect high quality data, like they deliver in for example Belgium or Germany. However, cost does not always reflect quality,” says Blanco.

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Novartis has selected the Department of Cancer Immunology at Oslo University Hospital to handle all its European trial samples from children with acute lymphoblastic leukaemia (ALL). The department analyses children’s samples as part of the screening process related to possible participation in the global Novartis CASSIOPEIA CAR-T trial.

B-Cell acute lymphoblastic leukaemia is a type of blood cancer that affects children and adolescents. Most patients get better with standard treatment, but 2–3% of them do not respond well to treatment and there is an increased risk that their leukaemia will relapse.

‘The Children´s Oncology Group is a network of hospitals and healthcare professionals in the US that specialises in treating children and adolescents with cancer. This group together with the global pharmaceutical company, Novartis, initiated the international clinical trial, CASSIOPEIA, that evaluates whether these high-risk patients could benefit from CAR-T treatment,’ says Liv Osnes.

Osnes is head of the Department of Cancer Immunology at Oslo University Hospital, and she, the other doctors in the department and the biomedical laboratory technologists contribute directly to CASSIOPEIA.

The department is the only laboratory in Europe that is involved in the trial. They work closely with a laboratory in Seattle in the US that is responsible for analysing the samples for North America.

‘The work we’re doing could be done by many other laboratories, and many others would certainly have liked to have had this assignment. We were suggested as a Novartis site by Paediatric Oncologist at Oslo University Hospital, Jochen Büchner, who has in-depth knowledge of CAR-T treatment,’ says Osnes.

Read the interview with Büchner about CAR-T treatment on the Barnekreftforening (the Norwegian Children’s Cancer Association) website (in Norwegian only.)

Watch the segment about Emily Whitehead, the first child in the world to receive CAR-T treatment on the Norwegian channel, TV2 (in Norwegian only.)

CAR-T, a potential last resort for very ill children

The purpose of the CASSIOPEIA trial is to investigate whether CAR-T may be suitable for children who do not respond adequately to standard treatment.

‘Children who have remaining leukaemia cells after the first courses of treatment and does not have the desired effect from the standard treatment of ALL are called high-risk patients. Unfortunately, these children often relapse, even after a bone marrow transplant, which was the treatment they were previously offered. CAR-T treatment is a new form of treatment, where the child’s own T cells are removed and modified so that when they are reinserted into the body they can recognise and kill cancer cells. Preliminary research indicates that the treatment is effective and has few side effects, and the trial hopes to confirm this,’ says Osnes.

In 2017, Novartis was the first company in the world to get approval for Kymriah, a type of CAR-T treatment for precisely this patient group with ALL.

Oslo University Hospital played a key role in the clinical trials that led up to getting Kymriah approved, and it was the only centre in Europe that enrolled adults and children in its trials. Liv Osnes and her colleagues also worked on these trials, so they have experience of the treatment and advanced analysis required for identifying and following up patients.

‘We analyse the samples we get from the paediatric oncology patients to see if they still have cancer cells in their bodies. This is done for enrolling them in the trial and then at certain intervals during the trial. We analysed the first sample in September 2019. During the trial, we will analyse a total of approximately 500–600 samples. This is a high volume for a lot of relatively demanding analysis,’ says Osnes.

The plan is for CASSIOPEIA to continue until 2027.

Feather in the cap

Erlend Carlson is Clinical Contract Manager at Inven2 and has been responsible for managing the agreement between Oslo University Hospital and Novartis in the USA.

‘This agreement is really a feather in the cap for Oslo University Hospital, Liv Osnes and her colleagues. It’s a long-term agreement and demonstrates that they have the required experience and expertise, and, not least, the infrastructure and state-of-the-art technology in place for dealing with this type of advanced analysis,’ says Carlson.

He believes that the unique expertise Oslo University Hospital has acquired in advanced analysis and CAR-T treatment is noteworthy.

‘The Oslo Myeloma Centre was recently assigned a new CAR-T trial on the treatment of myeloma, i.e. bone marrow cancer by a different pharmaceutical company. The hospital has the ability to contribute professionally to these global trials, and this may be an important niche within clinical trials for Norway,’ says Carlson.

Demanding logistics

‘When Europe was hit by the coronavirus pandemic in March, CASSIOPEIA’s progress was affected, but we have largely adapted now,’ Osnes explains.

‘The original plan was that the children and their families would go to Cassiopeia sites to have samples taken that would be analysed here in Oslo. Because of the coronavirus pandemic, we didn’t want to expose the children and their families to unnecessary travel, so the samples were taken at the nearest suitable hospital instead,’ says Osnes.

This placed extra demands on the staff in Oslo, who had to communicate and coordinate with many more hospitals than expected. Furthermore, the samples could arrive outside of normal working hours or during the weekend, as the pandemic also impacted the logistics and the transport of samples.

Osnes is in the process of training more colleagues in the required analysis of these samples, and she is very pleased that they are able to provide assistance in this important trial.

‘We’re really excited about this trial and its results. ‘We’re confident that it could be very promising for those children with the worst prognoses, so it’s exciting to be part of it,’ says Osnes.

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Inven2 hopes that we can shortly start so-called virtual clinical trials initiated by the industry in Norway. Virtual clinical trials involve the use of digital tools to collect the necessary data for getting a drug approved. Oslo University Hospital and the pharmaceutical company Bristol Myers Squibb (BMS) are very positive to virtual trials.

‘We have all the prerequisites for conducting successful virtual trials, and it could be a major advantage in attracting more clinical trials to Norway,’ says Siri Kolle. She holds the position of VP Clinical Trials at Inven2.

Virtual trials, also called ‘decentralised clinical trials’, involve the use of digital tools and remote follow-up of participants, among other things.

In Sweden, the Swedish Medical Products Agency is currently mapping the processes, etc. that are required for conducting virtual clinical trials safely and effectively in addition to what is already in place.

Jenny Söderberg is the project manager, and she pointed out in a press release that almost 70% of potential clinical trial participants are excluded for geographical reasons.

‘I imagine that the same applies to Norway. This shows the enormous potential that virtual trials have for improved patient participation. Virtual trials could mean better, broader and faster recruitment for a trial, which is the most important thing for the companies and the patients,’ says Kolle.

Siri Kolle is responsible for clinical trials in Inven2. Photo: Inven2 / Moment Studio.

Pharmaceutical industry focuses on new digital solutions in trials

Kolle thinks that the Swedish pilot project is exciting and is keenly following it and other initiatives related to virtual trials. She and her colleagues at Inven2 have already gathered information about the process at Oslo University Hospital based on inquiries from pharmaceutical companies at the start of 2020 about what can currently be done in relation to virtual studies in Norway.

‘It is allready possible to use videos for patient consultations and electronic consent. In addition, we have sent several large pharmaceutical companies the requirement specifications that Oslo University Hospital has for the use of information systems within the hospital, so they are aware of the hospital guidelines on this,’ says Kolle.

Susanne Hedenstedt appreciates this. She is the senior clinical site manager in the Nordic countries at the biopharma company, BMS, where she is also part of an internal, global, virtual clinical trials task force.

‘There is a global explosion taking place within virtual trials. Many pharmaceutical companies are considering the possibility of conducting all or parts of their trials digitally. BMS is planning to start a virtual cancer follow-up trial during 2020, and we hope to have a Norwegian hospital involved in this,’ says Hedenstedt.

Hedenstedt points out that BMS would like to start conducting virtual clinical trials, and she thinks that it could be a game changer for patients and for the development of new treatments, at least for some disorders.

‘Patient recruitment is one of the biggest challenges in clinical trials. It takes ages and delays the entire process of getting a new treatment approved. Furthermore, it happens quite often that some of the patients do not complete the entire trial period, which could be due to their disease or other factors like travel. Travelling back and forth to the hospital carrying out the trial is difficult for very ill patients. With virtual trials, we can involve the patient in a more suitable manner in their own home,’ says Hedenstedt.

The coronavirus pandemic has expedited work on virtual trials at BMS. The global state of emergency has meant that BMS, like many other pharmaceutical companies, has temporarily postponed starting new trials and recruiting patients for ongoing clinical trials.

‘We have taken these proactive measures to protect and ensure the safety of trial participants, our employees and hospital staff who are involved in clinical trials,’ says Hedenstedt.

She added that trials were also postponed to ensure that they were conducted in line with regulatory guidelines so that the scientific quality of the data remains high.

‘The coronavirus pandemic is going to lead to an explosion of virtual trials. It’s very positive that Inven2 wants to contribute to their introduction in Norway,’ says Hedenstedt.

Oslo University Hospital is positive to virtual trials

So what is actually the biggest difference between a standard clinical trial and a virtual, decentralised clinical trial?

The word decentralised spells it out; the main difference is that, as far as possible, the trial follow-up is moved from the hospital setting to the patient’s home. The patient has blood tests done at their GP’s surgery, and then uses various digital solutions to report data during the trial. More high-tech investigations like MRI scans, PET scans and X-rays will still have to be done at the hospital.

In Norway, the term telemedicine is often used about this type of patient follow-up.

Due to beeing a country with large distances, and many people in large parts of the country living far from hospitals or their GP, the use of telemedicine in Norway is more developed and advanced than in many other countries.

‘The Norwegian health service’s extensive experience of telemedicine means that we have all the prerequisites for being a pioneering country in the field of virtual trials,’ says Kolle.

A few more elements need to be put in place before we can progress from employing telemedicine to being able to conduct virtual clinical trials.

‘Electronic consent from patients to participate in a trial is one element, video consultations with a doctor or the trial personnel is another and there is also the extensive collection of patient-reported data. The latter involves the patient reporting on their physical and mental health based on their experience and health data obtained from different ‘wearables’, e.g. a heart monitor or similar that measures blood pressure and other vital functions,’ says Kolle.

These three elements are all currently used in the health service,’ says Peder Utne. He is head of the Department for Research Administration at Oslo University Hospital.

‘Digital tools are increasingly being used in researcher-initiated trials, and there is nothing preventing their use in industry-sponsored trials either. Naturally, data security has to be in place, i.e. that the digital solutions are safe for the participants to use and in line with international guidelines on data protection,’ says Utne.

An example of an ongoing virtual trial in Norway is a coronavirus trial called koronastudien, in which Oslo University Hospital is studying the risk of becoming infected with the coronavirus. Both electronic consent and questionnaires for collecting self-reported data are being used. So far, more than 100,000 people are participating in the trial.

‘We see virtual clinical trials as something very positive. Overall, I think most things are in place for conducting virtual trials. There will be some challenges depending on the design of the individual trial. This may apply to the specific systems that will be used for collecting data, as well as challenges connected with data protection and data security and also how amendments in a virtual trial should be reported to the Regional Committee for Medical and Health Research Ethics (REC), which is responsible for approving the trial,’ says Utne.

He thinks the coronavirus pandemic could be the single event that sparks a major digital boost within the healthcare sector.

‘In many ways, the pharmaceutical industry has been too traditional in its approach to conducting clinical trials, so it’s going to be exciting to see how thing progress from here,’ says Utne.

There is a good description of the differences between a standard clinical trial and a virtual clinical trial in the following research article: ‘Virtual Clinical Trials: Perspectives in Dermatology’.

Coronavirus accelerates the use of digital tools

Illustration photo of the coronavirus. Photo: Shutterstock.

The coronavirus pandemic has led to the extensive adoption of video consultations in Norwegian hospitals. Several of the country’s leading oncologists expressed this view at a webinar that the Dagens Medisin newspaper arranged in March about how the coronavirus pandemic has affected cancer treatment in Norway.

‘The pandemic has forced us all to rethink the way we do things and how we use digital tools. Look at the education sector and how teachers suddenly had to start teaching using video solutions, etc. The same thing happened in the healthcare sector. Healthcare professionals had to adapt overnight to, for example, some patients not wanting to go to hospital for fear of contracting the virus during the transport or in the hospital, and other patients who could not be exposed to such a risk. In some cases, a video consultation with a patient is easier and more effective for the patient as well as the healthcare provider,’ says Kolle.

She thinks that Norway should use the digital momentum that the coronavirus pandemic has created to change its practice in relation to clinical trials and, as far as possible, conduct them digitally in the future.

Since mid-March when the major hospitals were all at a ‘yellow’ level of emergency preparedness, the coronavirus pandemic affected the way ongoing trials were being conducted and particularly the start-up of new clinical trials in Norway. During a global healthcare crisis like we are currently experiencing, digital tools are invaluable for conducting clinical trials as normal despite the state of emergency; this is best for the patients,’ says Kolle.

Hospitals in Norway report they are now resuming trials that had been in progress and also starting new ones. In general, this is not the case globally. Clinical trials have been delayed, particularly in countries like Italy, Spain, the UK and the US that have been badly affected by the coronavirus pandemic.

‘There are many advantages to adopting virtual trials, so we’ve got to make this work. We’ve also got to realise that if we want to attract more clinical trials to Norway in the future, it’s essential that we are part of this development and adopt the use of new tools,’ says Kolle.

In the new action plan for clinical trials that the Ministry of Health and Care Services is currently working on, she has, on behalf of Inven2, emphasised the necessity of focusing on virtual clinical trials.

The coronavirus pandemic has led to changes in the way that clinical trials are conducted and highlighted issues and solutions related to digital clinical trials; see also https://www.dagensmedisin.no/artikler/2020/05/20/har-pandemien-endret-premissene-for-kliniske-studier-i-norge/ (in Norwegian only).

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