A peak into our member OncoInvent's laboratories, where the company is developing novel cancer treatments. Photo: OncoInvent

Clinical studies – important for Norwegian companies

OncoInvent

Together with our member Inven2, we wish to highlight the importance of facilitating clinical studies in Norway – in order to build a strong health industry and provide cancer patients with access to new, innovative treatments.

Read the original version of this article in Norwegian on Inven2’s website.

Inven2 handles agreements for clinical studies on behalf of the Cancer Clinic at Oslo University Hospital for most 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 these 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 is gentle for the patient, since the radiation only reaches a couple of cells in diameter,” said Hélen Johansen Blanco.

Blanco is Head of Clinical Operations at OncoInvent and, as such, she 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 below FACTS at the bottom of this article.

Helen Blanco, OncoInvent

Hélen Blanco, Head of Clinical Operations, OncoInvent. Photo: OncoInvent.

 

Close private-public collaboration

The overview from Inven2 shows eight Norwegian companies that are developing cancer treatments and have clinical studies at Oslo University Hospital at the moment. These are Targovax, PCI Biotech, Nordic Nanovector, Ultimovacs, Vaccibody, OncoInvent, BerGenBio and Exact Therapeutics. These companies are also members of Oslo Cancer Cluster.

What the companies have in common is that they are based on cancer research in 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.

Local trials are a part of building 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.

Kolle thinks that giving Norwegian companies the opportunity to test treatments locally should be a significant part of the Action Plan for Clinical Studies, which will be presented by the Norwegian Ministry of Health and Care Services before the end of the year.

In addition, some of these companies and other Norwegian pre-clinical stage companies, buy 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.

Siri Kolle, VP Clinical Trials, Inven2

Siri Kolle, VP Clinical Trials at Inven2. Photo: Inven2/Moment Studio.

 

A professional organisation

Jon Amund Kyte is the Head of the Department for Experimental Cancer Treatment at Oslo University Hospital.

“During the course of 20 years, this has developed into a professional department that can perform high-quality clinical studies on behalf of both Norwegian biotech companies and the global pharmaceutical industry. We have quick start-up and good patient recruitment. Moreover, we emphasise patient security, documentation, and data quality. These elements are essential to perform clinical studies,” said Kyte.

The department consists of three units:

  • The Clinical Cancer Research Unit at the Norwegian Radium Hospital, which is specialized in Phase I/II studies.
  • The unit for clinical study nurses, who support the running of the academic departments. In other words, they support the doctors from the different cancer groups who lead the studies, who are also called main investigators or investigators.
  • The “Clinical Trial Office”, which involves a project coordinator that performs all the administrative work for a clinical study, on behalf of the companies that require support and the investigators. This includes applications to the regional ethics committee, all internal agreements with the different hospital departments, agreements with Inven2, applications to the research council (Forskningsutvalget) at the hospital, etc.

“When we receive a request from a company who want to run a study, we contact an investigator in the relevant cancer group, to see if they can do the study. Then, the company goes to our Clinical Trial Office,” said Kyte.

Kyte said that they want to offer the companies a one-stop-shop. The system they have rigged around clinical studies is comprehensive.

“This rig saves both time and money for the company, which doesn’t need to call many different people at the hospital. At the same time, the responsible doctors, the investigators who will lead the study, are relieved from the administrative burden. It is then easier for the doctors to participate,” said Kyte.

Kyte said they are mindful of keeping their promises to the companies. They will rather decline a study if they can’t deliver all the company’s needs or they can’t recruit enough patients.

“We also offer more services to the small companies that are less experienced with clinical studies and that have less resources than the global companies,” said Kyte.

oncologist jon amund kyte

Jon Amund Kyte is the Head of the Department for Experimental Cancer Treatment at Oslo University Hospital. Photo: Sofia Linden

Norway needs to compete

The fact that OncoInvent can perform studies in Norway is important for the company. But it is not a matter of course. 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 following aspects are particularly important for us when we choose which locations to place our clinical studies: the quality of the clinical data, the implementation of the study, that the study is started quickly and that the clinical centre 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 centre with high recruitment of patients from the entire country and that performs the study at a high level. They have included four patients so far and the first dose level is confirmed 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 because there are 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 centre, led by gastro surgeon Stein Larsen, knows the patient group very well, Blanco points out.

“In addition, to have a quick start up the contractual work 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 with running studies in Norway, such as the lengthy application processes at the Norwegian State Medicinal Agency and the Regional Ethics Committee, compared to other countries, such as 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 that I have been responsible for, Norway has traditionally been relatively high in terms of cost and then we expect high quality data, like they deliver in for example Belgium or Germany. However, cost is not always in proportion to quality,” says Blanco.

image of drug radspherin(r) from oncoinvent

Radspherin® is a radiopharmaceutical product. It emits alpha rays that effectively kill cancer cells and is gentle for the patients, since the radiation only reaches a diameter of a couple of cells. Photo: OncoInvent.

Good at quick recruitment

Vaccibody and OncoInvent are proof that the Department for Experimental Cancer Treatments can start studies quickly.

OncoInvent publicised in May and June 2020 that the two phase I studies had begun with their first patient and Vaccibody advertised in July 2020 that its international phase II study of the DNA-based HPV vaccine in combination with a check point inhibitor from Roche also had begun.

In an opinion piece in the Norwegian medical newspaper Dagens Medisin, Kristina Lindemann, Staff Specialist at the Department of Gynaecologic Cancer and Head of Research Group for Gynaecological Oncology, wrote:

“We think it is great that Oslo University Hospital (OUS) was the first site and began with the first patient in this international study for patients with advanced cervical cancer.”

The reason they are quick at recruiting patients is because the Department for Experimental Cancer Treatments runs all applications and approval processes in parallel.

“We have checked and prepared the staff who will perform the study in advance, so that everything is in place when the company begins the study,” said Kyte.

The department gives their employees in-depth training, besides what has already been covered in the course “Good Clinical Practice” and have internal routines to secure good data quality.

When the clinical studies at Oslo University Hospital were stopped because of the corona pandemic in March, they were quickly up and running again because of the good internal routines.

“We never promise more than we can keep. If we can’t deliver a study, we may lose all future studies from that company or in that cancer type, and we don’t want to risk that. Our good reputation is all we have,” said Kyte.

Big potential for studies

Even if many things work well at the Clinical Trials Unit that Kyte heads up, Kyte wishes that clinical studies were a part of a more streamlined system at Norwegian hospitals.

“Clinical studies should be an integrated part of ordinary patient treatment, with dedicated specialists who have time set aside to work with clinical studies. Now, we need to obtain the price and capacity from each department of the hospital for the services we need for the studies. This process is both time-consuming and risky. If one department says no, then we must decline the study and if we are one investigator short, then the study cannot be run,” Kyte explains.

Kyte thinks that the streamlining of the processes should be assigned through documentation from the Ministry of Health and Care Services to the hospitals. This means that when the button “clinical studies” is pushed, it is just as binding for the hospital to complete as any other patient treatment.

“We run about 70 clinical studies at our hospital, this includes both industry studies and academic studies, but we have a much larger potential than this. We are a part of a ‘Comprehensive Cancer Center’ and have access to many cancer patients and competent cancer researchers at the hospital. We are very motivated to drive the interaction between research, business development and patients, that clinical studies represent,” said Kyte.

FACT

OncoInvent

  • OncoInvent was established ten years ago by serial entrepreneurs Roy Larsen and Øyvind Bruland. They are also behind cancer companies Algeta, Nordic Nanovector and newly established Nucligen. Tina Bønsdorff, Head of Research in OncoInvent, and Thóra Jónasdottir, board member in OncoInvent, also helped to establish the company in 2010.
  • Radspherin® is the main product from OncoInvent and is a radiopharmaceutical. This means it is a radioactive pharmaceutical that can kill cancer cells. Radspherin® consists of calcium carbonate particles marked with the radioactive isotope Radium-224, which is an alpha-emitting particle.
  • OncoInvent is in clinical development, with two phase I studies in Norway for the treatment of cancer metastasis in the abdominal cavity, from ovarian and colorectal cancer.
  • The radiation that Radspherin® emits is short and can therefore kill the cancer cells in the abdominal cavity more effectively without harming other parts of the body.
  • OncoInvent has their own production facilities for Radspherin® at their headquarters in Nydalen in Oslo, which is unusual for a small biotech company.
  • The company consists of almost 30 employees as of the end of this year.

Read more at OncoInvent’s official website

 

The Department for Experimental Cancer Treatment and Research Support

  • The main duty of the department is to contribute to more and better patient-focused research by facilitating for and implementing clinical studies.
  • It is led by Jon Amund Kyte.
  • It is a part of the Department for Cancer Treatment at Oslo University Hospital.
  • It consists of about 56 people connected with the department.
  • It runs about 70 clinical studies today, both from industry and academia.
  • It has studies in medical treatments, gene therapy, cancer vaccines, palliative treatments, radiation therapy, surgery and diagnostic procedures.
  • Read more about the work in the department in this interview with Jon Amund Kyte from Pharma Boardroom.

 

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Einar Martin Aandahl teamed up with engineers to develop the software tool PRJCTS, which simplifies research collaboration and data sharing. Photo: Oslo Cancer Cluster

Accelerating cancer research with data sharing

A new Norwegian technology enables cancer researchers to share data across research groups, institutions and country borders in order to faster reach new discoveries.

This is the story about a group of Norwegian researchers who got tired of the difficulties when collaborating across different hospitals. They decided to develop their own digital platform where research data can simply and safely be uploaded, shared and analysed across the globe.

Oslo University Hospital has now signed on to use the solution, called PRJCTS, to conduct nationwide clinical research on patients with the coronavirus.

The unique thing about the Norwegian start-up Ledidi is that the team consists of both doctors and engineers. Einar Martin Aandahl, CEO of Ledidi, is a surgeon with many years of research experience from Norway and the USA.

“We have done research for over 25 years, including in molecular biology, oncology and cancer surgery,” Aandahl explains. “We saw how difficult it was to collaborate on data and therefore we developed the software tool we needed.”

Today, researchers often work in several computer programs and must regularly import or export data. This is both time-consuming and leads to problems concerning data security. Moreover, statistical tools are slow and require previous training.

“We have brought together all the computer programmes that the researchers need into one software solution with a simple user interface,” Aandahl said. “The bridge between medicine and technology has made this possible.”

Aandahl thinks PRJCTS will simplify workflow and improve data security. The data will be kept in a cloud solution, which means it is always accessible from wherever researchers are located.

“This program has the potential to revolutionize how clinical research is conducted,” Aandahl said.

Since the majority of clinical cancer research today is done via multicentre international studies, it requires that different institutions can work together and share data securely. Moreover, cancer researchers often depend on large data sets and there is no limit to the scale of the project when using a cloud-based solution.

“The analysis tool is perfect for cancer research. It can perform many complicated analyses in a very short time frame,” Aandahl explained. ”The user interface is designed to help researchers see the larger patterns in the data.”

With the advent of personalized medicine, it is important for cancer researchers to easily identify subgroups in large data sets to tailor treatments for individual cancer patients.

Several prominent investors from the Norwegian finance milieu have already backed Ledidi. For example, Radforsk, the evergreen investment fund dedicated to oncology, recently pledged their support for the company.

“They have developed a product that will be extremely useful for researchers, clinicians and companies. We are happy to support them!” said Jónas Einarsson, CEO of Radforsk.

The agreement with Oslo University Hospital on covid-19 studies means a lot for Ledidi, who are proud that PRJCTS was approved of the hospital’s thorough regulations on data security and data privacy. Now, other clinical research environments have expressed interest in acquiring PRJCTS and Aandahl hopes it will help many more researchers worldwide.

“Our goal is that researchers can collect, analyse and share data faster, so that research can be accelerated and new treatments can be identified quicker,” Aandahl said.

Gert W. Munthe, Chairman of the Board, and Øystein Rekdal, PhD, CEO of Lytix Biopharma. Photo: Håvar Haug

Lytix Biopharma signs licensing agreement

Our member Lytix Biopharma has entered into a milestone agreement with Verrica Pharmaceuticals to license the company’s lead drug candidate against skin cancer.

The Norwegian start-up Lytix Biopharma from Tromsø has reached a new milestone. The company has licensed its lead drug candidate LTX-315 against skin cancer to the dermatology therapeutics company Verrica Pharmaceuticals. Verrica Pharmaceuticals will develop and commercialize LTX-315 for dermatologic oncology indications.

The drug is a first-in-class oncolytic peptide-based immunotherapy. Immunotherapy is a type of cancer treatment that mobilises the patient’s own immune system to fight cancer. Peptides are short chains of between two and fifty amino acids that can have many different sources or functions. Peptides hold great potential for both cancer therapy and diagnostics, through the development of anticancer peptides, use of peptides for drug delivery, and cancer targeting.

Clinical studies have shown that the drug LTX-315 from Lytix Biopharma has the ability to kill human cancer cells and induce a specific anti-cancer immune response when injected locally into tumours.

“We are pleased to enter into this collaboration with Verrica, which has significant expertise within the field of dermatology” said Øystein Rekdal, CEO of Lytix Biopharma. “Our lead drug candidate, LTX-315, has shown very promising efficacy and safety signals in cancer patients during Phase I/II studies and we are excited that this partnership with Verrica will expand the applications for LTX-315”

The agreement entitles Lytix Biopharma to up-front payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of more than $110M, as well as tiered royalty payments in the double-digit teens once Verrica successfully commercializes LTX-315 in dermatologic oncology indications.

Lytix Biopharma and Oslo Cancer Cluster

Lytix Biopharma has been a part of the innovation environment in Oslo Cancer Cluster Innovation Park since the building opened in 2015, utilising both offices and laboratory for research and development.

Oslo Cancer Cluster Incubator has offered the company its services in both private and shared laboratory spaces. In addition, Lytix Biopharma has been active in the animal laboratories at The Norwegian Radium Hospital (a part of Oslo University Hospital), which is located right next to the Incubator.

The researchers in Lytix Biopharma have gained their PhDs in the Incubator, in collaboration with its innovation environment. One of the company’s former researchers is now the laboratory manager in the Incubator.

“This shows how the innovation environments enrich one another in a positive sense, by sharing access to different services and thanks to the power of our geographic location,” said Bjørn Klem, general manager of Oslo Cancer Cluster Incubator.

Lytix Biopharma recently moved out of the Incubator after finishing their main project earlier this year and remains a member of Oslo Cancer Cluster.

Oslo Cancer Cluster Incubator is financed by SIVA, the Norwegian national infrastructure for innovation, consisting of incubators, business gardens, catapult centres, innovation enterprises, innovation centres and industrial real estate.

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New member: Hemispherian

Image of Oslo Cancer Cluster Innovation Park

In this article series, we will introduce the new members of our oncology cluster.

Our newest member Hemispherian is developing a better treatment option for patients with aggressive brain cancer.

Glioblastoma multiforme is one of the most aggressive types of cancer that begins within the brain. Current treatment options are limited to surgery, radiotherapy and chemotherapy, the median overall survival after diagnosis is only 15 months and is highly dependent on the success of the surgery.

A Norwegian company called Hemispherian is advancing a new method to treat glioblastoma multiforme. The molecules the company is developing are called GLIX1 and GLIX5. They target a mechanism that is unique to cancer cells and does not affect normal healthy cells. The molecules are highly toxic to cancer cells and have minimal side effects.

We talked to Adam Robertson, Chief Scientific Officer in Hemispherian, to find out more about the company and the research.

How is Hemispherian involved in health and cancer?

“We are advancing first-in-class therapeutics for the indication with the greatest unmet need in oncology — glioblastoma multiforme. Patients diagnosed with glioblastoma multiforme have dismal outcomes. Overall survival is measured in months with quality of life deteriorating rapidly. It is Hemispherian’s mission to provide superior treatment options.” Adam Robertson, Chief Scientific Officer, Hemispherian.

Why did Hemispherian become a member of Oslo Cancer Cluster?

“As a company focusing on developing cancer treatments Oslo Cancer Cluster is a natural fit for us. We are interested in Oslo Cancer Cluster’s extensive experience in the field and hope to benefit from advice and to make valuable contacts through Oslo Cancer Cluster’s network.” Adam Robertson, Chief Scientific Officer, Hemispherian.

Researcher Anette Weyergang shows the PCI technology to Norwegian Prime Minister Erna Solberg.

Grants awarded for PDT/PCI research

Erna Solberg visits PCI Biotech

Radforsk has granted seven research projects a total amount of MNOK 1,25 to further develop exciting research projects within photodynamic treatment and photochemical internalization.

Radforsk is an evergreen investor focusing on companies that develop cancer treatments.

“Radforsk has ploughed NOK 200 million of its profit back into cancer research at Oslo University Hospital. Of these, NOK 25 million, have gone to research in PDT/PCI. This year we grant seven projects a total of NOK 1,25 million,” says Jónas Einarsson, CEO of Radforsk.

Radforsk had received a total of seven applications by the deadline on 1 March. All projects were allocated funding.

The applications have been assessed by external experts.

The researchers who have received funding for PDT/PCI research in 2020 are:

  • Anette Weyergang is granted NOK 300 000 to the project: “Photochemical Internalization: Development of a novel tumor-specific protein toxin to defeat aggressive and resistant cancers”
  • Beáta Grallert is granted NOK 100 000 for the project: “Cancer-specific bioluminescence-PDT”
  • Judith Jing Wen Wong is granted NOK 100 000 to the project “Light-enhanced targeting of immunosuppressive tumor cells”
  • Kirsten Sandvig and Tore Geir Iversen are granted NOK 200.000 to the project “Drug-loaded Photosensitizer-Chitoscan Nanoparticles for cominatorial Chemo- and Photodynamic cancer therapy”
  • Mouldy Sioud is granted NOK 200.00 to the project “Antibody- and peptide-targeted photodynamic therapy to kill cancer cells”
  • Qian Peng and Henry Hirschberg are granted NOK 50 500 to the project “Improved therapy of brain tumors by PDT induced anti-tumor immune responses”
  • Qian Peng is granted 300 000 to the project “Photopheresis of patients with Crohn’s disease using 5-aminolevulinic acid”

Read about the projects that were funded in 2019 here.

FACTS

PDT/PCI

Cancer research in the field of photodynamic therapy and photochemical internalisation studies the use of light in direct cancer treatment in combination with drugs, or to deliver drugs that can treat cancer to cells or organs.

Radforsk

Since its formation in 1986, Radforsk has generated NOK 600 million in fund assets and channelled NOK 200 million to cancer research, based on a loan of NOK 1 million in equity back in 1986.

During this period, NOK 200 million have found its way back to the researchers whose ideas Radforsk has helped to commercialise.

NOK 25 million have gone to research in photodynamic therapy (PDT) and photochemical internalisation (PCI). In total, NOK 40 million will be awarded to this research.

Rafiq Hasan has been appointed CEO of EXACT Therapeutics, a Norwegian company with a new technology that can enhance the effect of chemotherapy.

Combating cancer with ultrasound

CEO Rafiq Hasan, EXACT Therapeutics

Our member EXACT Therapeutics gains pharma veteran Rafiq Hasan as CEO, reveals company name change and reports strong progress in first clinical trial.

Our member EXACT Therapeutics, formerly known as Phoenix Solutions, is a Norwegian biotech company developing an innovative platform technology that enables precision therapeutic targeting using ultrasound, with an initial focus in oncology.

The method is called Acoustic Cluster Therapy (ACT®) and has potential utility across multiple therapeutic areas. In oncology, the effect of chemotherapy is amplified through biomechanical effects induced by ultrasound insonation of microbubbles transiently trapped in the microvasculature.

In other words, ACT® is a method to enhance the delivery of chemotherapy with greater precision exactly to the target site of action. Patients receive an intravenous injection of ACT® comprising microbubbles and microdroplets, which are activated at the location of the tumour using conventional diagnostic ultrasound. This creates large bubbles that apply transient and controlled pressure to the vascular wall enabling greater extravasation of the co-administered chemotherapeutic. In essence, this means that more chemotherapy is “pumped” into the tumour. The potential is that chemotherapy can achieve greater therapeutic efficacy using standard of care chemotherapy, resulting in better clinical outcomes for patients living with cancer.

Watch the video below to learn more about the technology in detail.

Pharma veteran appointed CEO

EXACT Therapeutics recently appointed Rafiq Hasan as CEO to lead the company on its journey to commercialise ACT. Rafiq Hasan is a seasoned veteran of the pharma business and has held several top positions in Bayer and Novartis.

Dr Hasan commented: “There has been tremendous progress in the last 8 years within the field of microbubbles and sonoporation, driven forward by ACT® and EXACT Therapeutics. Through its targeted delivery, ACT® has the potential to enhance therapeutic efficacy of a multitude of products across numerous therapeutic areas. This exciting science with the potential to have a transformative impact on medicine and patients, and I could not pass up this opportunity to lead EXACT Therapeutics into its next phase. I am impressed with the preclinical data where ACT® shows efficacy across a range of drugs and disease models, whilst the clinical development is already underway with the Royal Marsden Hospital/the Institute of Cancer Research.”

Clinical trial ongoing

EXACT Therapeutics is now reporting strong progress in an ongoing clinical trial, which started at the Royal Marsden Hospital in September 2019. The clinical trial is investigating ACT® in combination with standard of care chemotherapy for treating colorectal and pancreatic cancers.

Watch the video from BBC News of the first patient to test the new treatment.

Visit the original homepage to learn more about EXACT Therapeutics.

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Per Håvard Kleven is the founder of Kongsberg Beam Technology, a company that develops technology for proton therapy centres, which will benefit cancer patients.

Improving proton therapy for cancer patients

Per Håvard Kleven, founder of Kongsberg Beam Technology

Kongsberg Beam Technology has entered an agreement with the Research Council of Norway to develop precision technology for proton therapy centres.

The grant will secure the company a total of NOK 23 million in support to develop a technology that improves the accuracy of proton therapy in combating cancer.

Many cancer patients receive radiotherapy treatment to destroy the cancer cells. The big negative side-effect is that healthy cells around the tumour are also damaged.

Proton therapy is more precise, which means that there is less damage to healthy tissue and organs surrounding the cancer. This reduces the unwanted side effects and improves the quality of life for the patient.

Kongsberg Beam Technology has developed a technology that increases the accuracy of proton therapy, even when the patient or their organs may be moving, for example while their lungs are breathing.

The technology creates a digital twin, a virtual copy of the patient. The digital twin gives a dynamic and predictive real-time image while the tumour is treated with proton therapy. This makes the treatment even more exact than before.

The system is called MAMA-K, which is short for Multi-Array Multi-Axis Cancer Combat Machine. The machine treats the tumour with several proton beams at the same time and is especially adapted for organs in motion. The system can be plugged into both current and new proton machines.

“The MAMA-K system will be clinically beneficial and yield significantly improved treatment effects to patients compared to state-of-the-art systems and procedures,” said Karsten Rydén-Eilertsen, Ph.D. Head of Section, Department of Medical Physics at Oslo University Hospital.

Oslo Cancer Cluster Incubator has assisted Kongsberg Beam Technology with business development advice and help in pursuing funding opportunities.

“The support from Oslo Cancer Cluster Incubator has been vital in reaching where we are today,” says Per Håvard Kleven, the founder of Kongsberg Beam Technology.

Semcon is another important collaboration partner, who is responsible for the technical and digital development of the project.

The first phase of the project will last until 2022. This has begun with securing the proof-of-concept, which means that Kongsberg Beam Technology has demonstrated that the concept has a verified practical potential. Now, a prototype is in development, which will be used to test the system. During phase 2 of the project, the system will be tested and verified until 2024 to prove that it works.

Norway currently does not have any proton therapy centres, but two are already in the planning stages. One will be in Oslo, at the Norwegian Radium Hospital, and one in Bergen, at Haukeland University Hospital. The first Norwegian cancer patients will be treated with proton therapy in 2024.

The MAMA-K system that Kongsberg Beam Technology are developing will be tested at The Norwegian Radium Hospital, a part of Oslo University Hospital.

Other collaboration partners are the University of Oslo and Onsagers.

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Ønsker virtuelle studier til Norge

This article was originally published on our member Inven2’s website and written by Elisabeth Kirkeng Andersen in Norwegian. Oslo Cancer Cluster supports this member’s initiative of introducing virtual clinical studies to Norway.

Inven2 håper at vi snart kan starte såkalte virtuelle kliniske studier på oppdrag fra industri i Norge. Virtuelle kliniske studier innebærer utstrakt bruk av digitale verktøy for å samle inn dataene som er nødvendig for at et legemiddel kan godkjennes. Oslo universitetssykehus og legemiddelfirmaet Bristol Myers Squibb (BMS) er veldig positive.

–Vi har alle forutsetninger for å lykkes med virtuelle studier og det kan være et stort fortrinn for å tiltrekke flere kliniske studier til Norge, sier Siri Kolle. Hun er ansvarlig for kliniske studier i Inven2.

Virtuelle studier kalles også «Decentralised Clinical Trials», og går blant annet ut på å ta i bruk digitale verktøy og avstandsoppfølging av studiedeltakere.

Det svenske Läkemedelsverket er i gang med en kartlegging i Sverige for å finne ut hva som kreves for å  gjennomføre virtuelle kliniske studier på en sikker og effektiv måte, og hva som allerede er på plass.

Jenny Söderberg er prosjektleder for dette og påpeker i en pressemelding at nær 70% av potensielle deltagere til kliniske studier er utelukket på grunn av geografiske hensyn.

–Jeg vil tro det samme gjelder for Norge. Dette viser hvilket enormt potensiale for bedre pasientbehandling som ligger i virtuelle studier. Ikke minst kan virtuelle studier bety bedre, bredere og raskere rekruttering til en studie, noe som er det viktigste får både firmaene og pasientene, sier Kolle.

Siri Kolle, ansvarlig for kliniske studier i Inven2.

Legemiddelindustrien på ballen

Kolle synes det svenske pilotprosjektet er spennende, og følger spent med på det og andre initiativ rundt virtuelle studier. Hun og kollegaene i Inven2 har allerede gjennomført en forundersøkelse ved Oslo universitetssykehus, basert på at de i starten av 2020 fikk flere henvendelser fra legemiddelfirmaer om hva som er mulig å gjøre innen virtuelle studier i Norge i dag.

–Både videoløsninger for pasientkonsultasjon og elektronisk samtykke kan enkelt tas i bruk allerede. I tillegg har vi sendt flere store legemiddelfirmaer kravspesifikasjonene som Oslo universitetssykehus har, på bruk av informasjonssystemer, så de er informert om retningslinjene sykehuset har på dette, sier Kolle.

Det setter Susanne Hedenstedt stor pris på. Susanne er senior prosjektleder for kliniske studier i Norden i biopharma selskapet BMS, hvor hun også er med i en intern, global, arbeidsgruppe innen virtuelle kliniske studier.

–Virtuelle studier bobler i verden. Det er mange legemiddelfirmaer som ser på muligheten for å gjennomføre hele eller deler av studiene sine digitalt. BMS planlegger å starte opp en virtuell oppfølgingsstudie innen kreft i løpet av 2020, og vi håper å få med et norsk sykehus i den studien, sier Hedenstedt.

Hedenstedt er tydelig på at BMS ønsker å gå i gang med virtuelle kliniske studier, og tror dette kan være en «gamechanger» for pasientene og for utvikling av nye behandlinger, i alle fall innen noen sykdommer.

– Pasientrekruttering er en av de største utfordringene i kliniske studier. Det tar lang tid og forsinker hele prosessen med eventuelt å få godkjent en ny behandling. I tillegg skjer det ofte at en del av pasientene ikke fullfører hele studieperioden. Det kan være på grunn av sykdommen eller andre faktorer, som reisevei. Det er tøft for svært syke pasienter å reise tur-retur til et sykehus hvor studiene gjennomføres. Gjennom virtuelle studier kan vi involvere pasienten på en mer hensiktsmessig måte i deres eget hjem, sier Hedenstedt.

Koronapandemien har satt fortgang i arbeidet med virtuelle studier i BMS. Den globale unntaktstilstanden har ført til at BMS, som ett av mange legemiddelfirmaer, har satt en midlertidig pause for oppstart av nye studier og rekruttering av pasienter til kliniske studier.

– Vi har tatt disse proaktive grepene for å beskytte og ta vare på sikkerheten til både studiedeltakere, våre ansatte og de ansatte på sykehusene som jobber med kliniske studier, sier Hedenstedt.

Hun påpeker at pausen også er satt for å sikre at studiene gjennomføres i tråd med regulatoriske retningslinjer og at dataene holder høy vitenskapelig kvalitet.

–Koronapandemien kommer til å føre til en eksplosjon av virtuelle studier. Det er veldig positivt at Inven2 ønsker å bidra til å innføre dette i Norge, sier Hedenstedt.

Oslo universitetssykehus er positivt innstilt

Så hva er egentlig den største forskjellen på en vanlig klinisk studie og en virtuell, desentralisert klinisk studie?

Begrepet desentralisert er beskrivende, fordi hovedforskjellen er at studieoppfølgingen flyttes så mye som mulig fra et sykehus hjem til den enkelte pasienten. Han eller hun bruker sitt lokale legekontor for blodprøver, og ulike digitale løsninger for å rapportere inn data i studien. Mer avanserte undersøkelser som MR, PET-skan og røntgen må fremdeles gjennomføres på sykehus.

I Norge har begrepet telemedisin gjerne blitt brukt om denne typen oppfølging av pasienter

Telemedisin er et område Norge er langt framme på internasjonalt, på grunn av vår spredte befolkning som i store deler av landet bor langt unna sykehus eller fastlegekontor.

–Det norske helsevesen sin lange erfaring med telemedisin innebærer at vi har alle forutsetninger for å være et foregangsland innen virtuelle studier, sier Kolle.

Noen flere elementer må på plass for å gå fra telemedisin til virtuell gjennomføring av kliniske studier.

–Elektronisk samtykke fra pasientene til å delta i en studie er et element, videokonsultasjoner med lege eller studiepersonell er et annet, og i tillegg kommer utstrakt innsamling av pasientrapporterte data. I dette ligger det at pasienten selv rapporterer om egen fysisk og psykisk helse basert på egen erfaring og helsedata hentet fra ulike former for «wearables», det vil si en pulsklokke eller lignende som måler blodtrykk og andre vitale funksjoner, sier Kolle.

Alle disse tre elementene er i bruk i helsevesenet i dag, sier Peder Utne. Utne leder avdeling for administrativ forskningsstøtte ved Oslo universitetssykehus.

–Digitale verktøy brukes i stor grad i forskerinitierte studier, og det er ingenting i veien for å ta det i bruk i industrisponsede studier. Det som må være på plass er selvfølgelige datasikkerhet, det vil si at de digitale løsningene er trygge i bruk for deltagerne og i tråd med internasjonale retningslinjer for personvern, sier Utne.

Et eksempel på en pågående, virtuell studie i Norge, er koronastudien der Oslo universitetssykehus kartlegger risiko for å bli smittet av koronaviruset. Her bruker de både elektronisk samtykke og spørreskjema for å innhente egenrapporterte data. Så langt har studien over 100.000 deltagere.

–Vi er veldig positive til virtuelle kliniske studier. På et generelt grunnlag mener jeg det meste er på plass for å gjennomføre dette. Det vil være noen utfordringer som er avhengig av den enkelte studiens design. Dette kan gjelde de spesifikke systemene som skal tas i bruk for å hente inn data, samt utfordringer knyttet til personvern og datasikkerhet, samt hvordan endringer i en virtuell studie skal rapporteres til Regional Etisk Komite´(REK), som er ansvarlig for å godkjenne studien, sier Utne.

Han mener at koronapandemien kan være enkelthendelsen som sparker i gang et stort digitalt løft innen helsektoren som en helhet.

–Det er nok på mange måter sånn at legemiddelindustrien har vært for tradisjonell når det gjelder gjennomføringen av kliniske studier, så det blir spennende å se hva som kommer nå, sier Utne.

Les en god beskrivelse av forskjellene på en vanlig kliniske studie og en virtuell kliniske studie i denne forskningsartikkelen «Virtual clinical trials: Perspectives in Dermatology».

Korona med digitalt dytt

Koronapandemien har ført til at videkonsultasjoner har blitt tatt i bruk som aldri før ved norske sykehus. Det fortalte flere av landets fremste kreftleger på et webinar Dagens Medisin arrangerte i mars, om hvordan koronapandemien har påvirket kreftbehandlingen i Norge.

–Pandemien har tvunget oss alle til å tenke nytt og ta i bruk digitale verktøy på en annen måte en før. Se på skolesektoren hvordan lærerne fra én dag til en annen måtte ta i bruk videoverktøy for å undervise. Det samme har skjedd med de ansatte i helsesektoren, som fra en dag til en annen måtte forholde seg til pasienter som ikke ønsket å møte opp på sykehuset i frykt for å bli smittet der eller på reisen, eller pasienter som ikke burde utsette seg for risikoen. I noen tilfeller er videokonsultasjon med pasienter enklere og mer effektivt, for både pasient og behandler, sier Kolle.

Hun mener Norge bør utnytte det digitale momentumet koronapandemien har medført, til å endre praksis innen kliniske studier og utføre så mye som mulig digitalt framover.

–Koronapandemien påvirket fra midten av mars av gjennomføringen av pågående studier og særlig oppstart av nye kliniske studier i Norge, siden de store sykehusene alle var i gul beredskap. I en slik global krisesituasjon er digitale verktøy gull verdt for å gjennomføre kliniske studier som normalt på tross av unntakstilstanden, det er det beste for pasientene, sier Kolle.

Nå melder sykehusene i Norge at de er i gang igjen med både pågående studier og oppstarten av nye. Det er ikke tilfellet i verden generelt, særlig land som har blitt sterkt rammet av koronapandemien som Italia, Spania, Storbritannia og USA, melder om store forsinkelser.

–Oppsiden med å ta i bruk virtuelle studier er så mange, så dette må vi få til. I tillegg må vi ta inn over oss at ønsker vi flere kliniske studier til Norge i fremtiden, er vi helt avhengige av å være med på utviklingen og ta i bruk nye verktøy, sier Kolle.

Hun har på vegne av Inven2 spilt inn nødvendigheten av å satse på virtuelle kliniske studier til den nye handlingsplanen for kliniske studier som Helse- og omsorgsdepartementet arbeider med nå.

New member: Adjutec Pharma

Image of Oslo Cancer Cluster Innovation Park

In this article series, we will introduce the new members of our oncology cluster.

Antibiotic resistance is one of the treats for cancer patients’ survival. Meet our new member Adjutec Pharma, a company with new technology against multi-drug resistant bacteria.

Multi-drug resistant bacteria are spreading across the globe and cannot easily be treated with antibiotics. Cancer patients are an especially vulnerable group, because their immune systems may be extra susceptible to different bacteria and virus while undergoing treatment.

In Norway, new technology has been developed to combat multi-drug resistant bacteria. We asked the founder of the company Adjutec Pharma, Professor Pål Rongved, to tell us more about this new tecknologi.

Who is Adjutec Pharma and how are you involved in health and cancer?

Antibiotic resistance can render modern medicine useless, if new technology is not found. The biotech start-up AdjuTec Pharma AS was established in 2019 by the main grounder, Professor Pål Rongved, UiO, to develop their cutting edge technology (ZinChel). Their compounds have proved very effective as low-toxic adjuvants in combination with last resort antibiotics against a wide range of multidrug-resistant Gram-negative bacteria. These are increasingly spreading across the globe. These bacteria are at the top of the WHO’s list of 12 ‘priority pathogens’, representing the most dangerous bacteria in the world.

Why did Adjutec Pharma become a member of Oslo Cancer Cluster?

“About 20 % of the cancer patients are dying from infectious diseases, making the technology highly relevant for the cancer clinic. The OCC Incubator is a unique partner for networking and a number of services that aids exchange of expertise, comprises a spectrum of companies, institutions and organizations. This gives a valuable opportunity to contribute to aiding the cancer patients with their secondary infections, and further stimulates research collaborations,” said Rongved.

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Richard Godfrey, CEO, BerGenBio - a Norwegian biotech company that has developed a cancer treatment that is now being trialled on COVID-19 patients.

Norwegian cancer drug in COVID 19-programme

Richard Godfrey, CEO BerGenBio

British health authorities are testing six medicines against the coronavirus and bemcentinib from the Norwegian biotech BerGenBio is the first treatment to be tested.

Bemcentinib is an AXL inhibitor that our member BerGenBio has developed to treat cancer, by boosting the patient’s immune system. Now, bemcentinib will be evaluated by the British government as a treatment option for COVID-19 patients.

On Tuesday, the British government launched the ACCORD programme (Accelerating COVID-19 Research & Development platform). It is an accelerated research and development programme for the treatment of COVID-19.

So far, no medicine has been found to treat COVID-19, but the work group behind ACCORD has selected six promising candidates, of which the drug bemcentinib from BerGenBio is the first to be trialled.

The study will include 120 patients, of which 60 are COVID-19 patients currently in hospital and the other 60 are a control group who receive standard treatment. The first data from the clinical testing may be available already in the next few months. If the results are positive, the clinical trial will continue to a larger second stage (phase 3).

The study is financed by the Department of Health and Social Care and UK Research and Innovation.

Bemcentinib is already in clinical trials as a cancer treatment and early testing has shown that the treatment has antiviral effects.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are delighted to be part of this initiative which is a ground-breaking partnership between government, academia and industry.  We are hopeful that bemcentinib can play a significant role in the global effort to find suitable treatment options for COVID-19 patients, which has had such serious implications for so many people and thereby ease pressures on hospital intensive care units, and ultimately treat thousands of patients. We are poised to commence dosing in the coming days and will provide results as soon as is practically possible.”

Read the press release from BerGenBio

Letter from CEO Richard Godfrey on COVID-19 Clinical Trial

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