Carlos de Sousa, CEO of Ultimovacs, who has launched a new collaboration study in ovarian cancer with the Nordic Society of Gynaecological Oncology, the European Network of Gynaecological Oncological Trial Groups and AstraZeneca. Photo: Ultimovacs

New clinical study in ovarian cancer

Carlos de Sousa, CEO of Ultimovacs

Our member Ultimovacs has announced a new Phase II clinical trial for ovarian cancer patients.

DOVACC is a new clinical study from Ultimovacs that will investigate the effect of combining the cancer vaccine UV1 with a checkpoint inhibitor and a PARP inhibitor in patients with ovarian cancer.

This is the first time this type of combination treatment is tested in a clinical study. Patients with advanced ovarian cancer, who have relapsed after receiving two rounds of chemotherapy treatment are eligible for the study.

The study will be sponsored by the Nordic Society for Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU). This group is a part of the European Network of Gynaecological Oncological Trial Groups (ENGOT), which is also a part of the study.

“The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs.

The global pharmaceutical company AstraZeneca, will contribute with two different cancer drugs to the study. These include the checkpoint inhibitor durvalumab and the PARP inhibitor Olaparib.

Ultimovacs is evaluating the company’s universal cancer vaccine UV1 and has also received NOK 10 million from Innovation Norway.

“A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options,” commented Carlos de Sousa, CEO of Ultimovacs.

“The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer,” added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT.

DOVACC is a randomised study, which will include 184 patients. The study is divided into three control arms, or patient groups. The first group includes 46 patients who will receive PARP inhibitor. The second group includes 46 patients who will receive both the PARP inhibitor and the checkpoint inhibitor. The third group includes 92 patients who will receive UV1 and both AstraZeneca drugs.

The multi-centre study will be held at more than 30 hospitals in about 10 countries in Europe.

The first patient will be recruited during the first half of 2021 and results are expected in 2023.

Ultimovacs currently have a broad clinical development programme, with over 500 patients enrolled in Phase II trials.

Read more in the press release from Ultimovacs

 

Oslo Cancer Cluster's member wheel provides a glimpse of our organisation's more than 90 members. Click on "Members" in the menu above to access the full overview and our members' websites.

Top news 2020 from Oslo Cancer Cluster’s members

Despite the challenges with the corona pandemic, several of our members have distinguished themselves with good news and positive updates throughout the year.

The corona pandemic made 2020 a challenging year for many companies, but the health industry showed a remarkable ability to adapt to the new circumstances. For companies running clinical trials, two major challenges have been restricted access to hospitals, which forced a temporary stop to clinical trials in March, and disruptions to the global supply chain.

Healthcare companies have worked tirelessly despite these obstacles. For that reason, we wish to highlight ten of our Norwegian members (in alphabetical order) who caught our attention this year.

Adjutec Pharma

Pål Rongved, Adjutec Pharma.

Pål Rongved, founder of Adjutec Pharma. Photo: UiO/Terje Heiestad

Adjutec Pharma is a Norwegian start-up with a technology called ZinChel against antibiotic multi-resistance, a condition that can become life threatening, especially for cancer patients. This summer, Adjutec Pharma secured exclusive rights to the patents for the ZinChel technology and will raise more money to accelerate development of the drugs in collaboration with researchers at University of Oslo. Adjutec Pharma also received several grants, including NOK 16 million in innovation support from the Norwegian Research Council. The company will now raise 20 million dollars in investments to reach phase II clinical trials, including public and private funding.

BerGenBio

Richard Godfrey, CEO BerGenBio

Richard Godfrey, CEO of BerGenBio. Photo: BerGenBio

The Bergen-based Norwegian clinical-stage biopharmaceutical company that develops AXL kinase inhibitors (a form of cancer immunotherapy) has had a remarkable year. In April, the company was selected as the first to be included in the ACCORD trial, which will test the company’s cancer therapy as a treatment for hospitalised Covid-19 patients. In May, the company raised NOK 500 million in an oversubscribed private placement. The company has also consistently reported positive results from the ongoing phase II trial testing a combination treatment of the AXL kinase inhibitor Bencemtinib and immunotherapy Keytruda on non-small cell lung cancer (NSCLC) patients.

Visit BerGenBio’s official website to learn more

Exact Therapeutics

Rafiq Hasan, CEO, EXACT Therapeutics

Rafiq Hasan, CEO of Exact Therapeutics. Photo: Exact Therapeutics

Exact Therapeutics is a clinical-stage Norwegian biotech company developing a technology platform for more targeted cancer treatments, called Acoustic Cluster Therapy. This year, the company changed its name from Phoenix Solutions to Exact Therapeutics and appointed Rafiq Hasan as new CEO. Shortly after, the company was listed on Merkur Market (Oslo Stock Exchange) and its value skyrocketed to nearly NOK 1 billion during the first day of trading. In September, Exact Therapeutics restarted its phase I ACTIVATE study, enrolling the first patient at the Royal Marsden Hospital in London. The study is assessing the safety, tolerability and preliminary efficacy of Acoustic Cluster Therapy in combination with chemotherapy in patients with metastatic colorectal and pancreatic cancer.

Visit Exact Therapeutic’s official website to learn more

Kongsberg Beam Technology

Per Håvard Kleven, founder of Kongsberg Beam Technology

Per Håvard Kleven, founder of Kongsberg Beam Technology. Photo: Oslo Cancer Cluster

Kongsberg Beam Technology has developed a technology that increases the accuracy of proton therapy, a treatment that is more precise than traditional radiotherapy against cancer. This year, the Norwegian Research Council awarded a grant of NOK 23 million in support of the development of this technology. The company has partnered with Semcon to develop the control and monitoring systems, a full-scale prototype for testing, as well as a digital twin of a patient or organ. The experienced CEO Kerstin Jakobsson has also joined Kongsberg Beam Technology during 2020.

Ledidi

Einar Martin Aandahl, founder of Ledidi. Photo: Oslo Cancer Cluster

The Norwegian start-up Ledidi offers a cloud-based software solution that makes sharing of health data easier for researchers. This year, the software was approved for all clinical trials on Covid-19 at Oslo University Hospital. This both simplifies the workflow for medical researchers and makes it possible to share data more securely between clinical institutions and countries. It can also perform complicated statistical analyses on large data sets in a short time frame, which makes it ideal for clinical studies on cancer.

Visit Ledidi’s official website to learn more

NEC OncoImmunity

Dr. Richard Stratford and Dr. Trevor Clancy, founders of OncoImmunity

Richard Stratford and Trevor Clancy, founders of OncoImmunity. Photo: Oslo Cancer Cluster

The Norwegian bioinformatics company NEC OncoImmunity AS offers innovative software based on machine learning. The artificial intelligence (AI) platform the company has developed can identify neoantigens, which are key to unlocking the immune system and combating cancer. NEC OncoImmunity made headlines this year by adapting the company’s AI platform towards the development of blueprints for a corona vaccine. In October, NEC OncoImmunity also teamed up with Oslo University Hospital to develop a diagnostic tool for Covid-19 using AI.

Visit NEC OncoImmunity’s official website to learn more

OncoInvent

OncoInvent

Photo: OncoInvent

OncoInvent is a Norwegian pharmaceutical company developing new innovative radiopharmaceutical products to treat cancer patients. The company was established ten years ago by serial entrepreneurs Roy Larsen and Øyvind Bruland. This year, OncoInvent initiated its first clinical studies: two phase I trials in May and June on ovarian and colorectal cancer with progression to the abdominal cavity. The studies are performed at Oslo University Hospital, which means that Norwegian cancer patients gain access to new and innovative treatments long before the treatments reach the market.

Visit OncoInvent’s official website to learn more

Photocure

Dan Schneider, CEO of Photocure.

Dan Schneider, CEO of Photocure. Photo: Photocure

Photocure is a bladder cancer company with a unique light technology, which was developed in Norway, to better detect cancer cells. In January, Photocure’s groundbreaking technology was highlighted in the LA Fox 11 news programme. The biggest news of the year was when Photocure regained worldwide rights to the product Hexvix. Photocure also secured a European patent for Cevira, a photodynamic drug device against cervical cancer. Photocure then appointed Susanne Strauss as Vice President and General Manager of Europe. Moreover, a global phase III trial of Cevira was initiated by the company’s partner Asieris.

Visit Photocure’s official website to learn more

Ultimovacs

Carlos de Sousa, CEO of Ultimovacs. Photo: Ultimovacs

Ultimovacs is a pharmaceutical company developing novel immunotherapies against cancer. The lead product is a universal vaccine called UV1 that has the potential to be used against most cancer types. This year, Ultimovacs appointed Carlos de Sousa as new CEO of the company. In June, the company recruited the first patients in two new phase II studies called INITIUM and NIPU, which will recruit up to 400 patients with melanoma and mesothelioma respectively. A third phase II clinical trial is in the planning with an unknown large pharmaceutical partner. The purpose of these studies is to confirm the results from the company’s completed phase I trials, which have shown promising survival data for several years now. Last week, Ultimovacs announced five-year survival data for melanoma patients who received UV1 in combination with ipilimumab – 50% of the patients were still alive.

Visit Ultimovacs’ official website to learn more

Vaccibody

Agnete B. Fredriksen, founder of Vaccibody. Photo: Vaccybody

Vaccibody is a Norwegian clinical-stage biopharmaceutical company discovering and developing novel immunotherapies. When the corona pandemic struck, the company quickly expanded its technology platform to include infectious diseases; both a strategy and preclinical results of a vaccine was released last week. In October, Vaccibody signed the largest biotech agreement ever in Norway with Genentech (Roche). The agreement is worth up to 715 million dollars in near term and milestones, in addition to low double-digit tiered royalties on sales of commercialized products. Vaccibody was shortly after listed on Merkur Market (Oslo Stock Exchange). Last but not least, co-founder and owner Agnete B. Fredriksen received the Research Council of Norway’s prestigious Innovation Award in November.

Visit Vaccibody’s official website to learn more

 

Oslo Cancer Cluster has more than 90 members, including Norwegian and international companies, research and financial institutions, university hospitals and organizations – all working in the cancer field. They represent the entire oncology value chain, doing everything from exploratory research to selling therapeutics and diagnostics to global markets.

Please visit our member overview page and click on the logos to access the website of each member.

 

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Øystein Soug, CEO of Targovax, was pleased to announce the new results from the clinical study during a webcast this week. Photo: Targovax

Positive results from Targovax’s skin cancer study

Our member Targovax announced an update from the company’s clinical study on melanoma patients this week.

The clinical study offers Targovax’s medicine ONCOS-102 in combination with the checkpoint inhibitor Keytruda to skin cancer patients with serious disease progression. The patients were all at Stage III and Stage IV at the beginning of the trial and had been through the standard of care. They had no other treatment options after failing anti-PD-1 treatment.

What is anti-PD1 treatment?

PD-1 is a protein that is found on T cells (a type of white blood cell that is part of the immune system) that helps keep the body’s immune responses under control. When PD-1 binds to another protein called PD-L1, which can be found on normal cells and in higher amounts on some cancer cells, it keeps the T cells from destroying cells, including cancer. Some anti-cancer drugs called immune checkpoint inhibitors are used to block PD-1. This releases the brakes on the immune system and increases the ability of T cells to kill cancer cells.

Checkpoint inhibitors have revolutionized the treatment of cancer in the last ten years, but they do not work on all cancer patients. Some patients do not have the right types of T cells for the treatment to work. The oncolytic virus called ONCOS-102 developed by Targovax is a combination product, which tricks the immune system to produce these T cells that can help destroy cancer cells.

3d illustration of a cancer cell and lymphocytes

Illustration of cancer cells under attack from lymphocytes (white blood cells), part of the immune system.

 

Partial or complete responses

According to the newly released data from Targovax, 7 of the 20 patients in the clinical study had partial or complete responses after receiving the combination treatment of the immune checkpoint inhibitor Keytruda and the oncolytic virus ONCOS-102. The patients had overall more than a 30 per cent reduction of their tumours. One patient had a complete response, while the overall response rate was 35 per cent.

Systemic effects

Two patients had a response in non-injected lesions. This means that a response was observed in melanoma lesions that had not been injected with the oncolytic virus. This is what is known as a systemic effect and has not been seen with oncolytic viruses before. Two non-injected lesions had completely disappeared on the patients in the study group.

“These impressive efficacy data in anti-PD1 refractory melanoma are the most important clinical results for Targovax to date,” Øystein Soug, Chief Executive Officer of Targovax, commented.

“The data clearly confirm our hypothesis that ONCOS-102 can benefit cancer patients resistant to checkpoint inhibition by triggering local and systemic immune activation,” Soug continued. “They also provide evidence of clinical efficacy and establishes ONCOS-102 as one of the most promising combination partners to checkpoint inhibitors. We will now carefully analyze the immunological data and are planning for a confirmatory melanoma trial for the ONCOS-102 and checkpoint inhibitor combination.”

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The Norwegian clinical stage biopharmaceutical company BerGenBio develops AXL inhibitors against cancer, which are now being tested to treat Covid-19 patients. Photo: Nils Olav Mevatne/BerGenBio

Cancer drugs being tested to treat Covid-19

Bergenbio image of researchers in the lab

Our member BerGenBio is currently testing the company’s cancer medicine as a potential treatment for Covid-19.

Another one of our members has emerged this year as an active contributor in the fight against the corona pandemic. BerGenBio, a Norwegian clinical-stage biopharmaceutical company, is running a clinical trial to assess the safety of the company’s cancer drug to treat Covid-19 patients.

BerGenBio develops novel selective AXL kinase inhibitors, an advanced type of cancer treatment. In cancer, AXL suppresses the body’s immune response to tumours. In many different cancer indications, AXL can be the reason that treatments fail.

BerGenBio’s primary drug candidate is called Bemcentinib and is currently being investigated in several ongoing cancer clinical trials, against both lung cancer and leukaemia.

This year, BerGenBio announced the company will also test the drug as a treatment for hospitalised Covid-19 patients. The phase II study, which will recruit a total of 120 patients hospitalised with Covid-19 at different sites in India and South Africa, recruited its first patient in India this week.

“We are pleased to expand the BGBC020 study to patients in India, where incidences of COVID-19 remain high, following the commencement of dosing in South Africa in October,” Richard Godfrey, Chief Executive Officer of BerGenBio, commented. “There are still no approved therapies for patients hospitalised as a result of COVID-19 infection and we are keen to continue exploring the profile of bemcentinib as a potential treatment.”

Promising solutions from health industry

BerGenBio is one of our many members that have joined the effort against corona this year with their science, technology and knowledge.

Another example is the Norwegian biotechnology company Vaccibody, who have used the company’s cancer vaccine technology to expand their activities to do research into infectious diseases.

Similarly, our member NEC OncoImmunity has adapted the company’s artificial technology platform for improving cancer immunotherapies to design vaccine blueprints against the coronavirus.

Moreover, our member the Norwegian start-up company Ledidi has contributed with a data-sharing software that will be used to increase research collaboration in Oslo University Hospital’s clinical trials on Covid-19.

Several of the larger pharmaceutical companies in our membership base are also in the race to deliver effective vaccines against the coronavirus in 2021.

The corona pandemic has left many sectors of society across the world struggling, but the health industry has proved that it holds promising solutions to a global challenge. Medical innovations and the enthusiasm of researchers continue to shine a positive light at the end of this tunnel.

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Prime Minister Erna Solberg visited PCI Biotech to learn about the PCI technology from researcher Anette Weyergang. Photo: Oslo Cancer Cluster Innovation Park

PDT/PCI application grant 2021

Erna Solberg visits PCI Biotech

Radforsk annually distribute funding to photodynamic therapy and photochemical internalization (PDT/PCI) related research. Application deadline will for 2021 be January 15. Please note that one project will be chosen to receive a larger project grant on 1,25 MNOK per year for 3 years, in this application round.

 

Radforsk has one main call for applications for funding for research projects relating to PDT or PCI each year:

  • The maximum amount that can be applied for per project is NOK 300,000, and the total amount to be awarded for all projects is NOK 1,250,000
  • Funding for a larger project will be announced every other year, 2019, 2021 etc:
    The chosen project will be awarded a total amount of NOK 3,750,000,  NOK 1,250,000 every year for three years without sending new applications
  • All Oslo University Hospital employees can apply for funding
  • The deadline for the call for applications will be 15 January 2021
  • Please see application details here: Guidelines for resources to PDT/PCI related research (English) and Retningslinjer ved tildeling av forskningsmidler (Norwegian)

 

Applications, containing a description of the project, may be sent to:
Bente Prestegård: bp@radforsk.no

If you have received a grant for PDT/PCI projects previously, you must provide a project report with your new application.

 

Background:

The objective for Radforsk is to advance cancer research and contribute to better and more effective diagnoses, treatment, care, and prevention of cancer. Research funding is one of several instruments Radforsk has and uses to reach these goals.

Radforsk’s board of directors has decided that funding will be announced for research projects in the areas photodynamic therapy (PDT) or photochemical internalisation (PCI). This decision is due to a prior agreement involving Photocure from when Radforsk was technology transfer office for the Norwegian Radium Hospital.

Professor Pål Rongved introduced the ZinChel technology that fights antimicrobial resistance at Oslo Life Science Week 2017. Photo: UiO/Terje Heiestad

Norwegian invention to fight antibiotic resistance

Professor Pål Rongved introduced the ZinChel technology that fights microbial resistance at Oslo Life Science Week 2017. Photo: UiO/Terje Heiestad

A new Norwegian technology may help stop the increase of antibiotic multi-resistance.

Antibiotic resistance is growing, and the world is running out of treatment options. In 2020, approximately 700 000 people will die from antibiotic-resistant infections. By 2050, as many as 10 million deaths are forecast.

Increasing numbers of cancer patients also develop resistance to multiple antibiotics, which potentially leads to life-threatening conditions. The World Health Organization (WHO) writes that: “Without effective antibiotics, the success of major surgery and cancer chemotherapy would be compromised.”

A Norwegian solution for global challenge

New Norwegian technology from the start-up Adjutec Pharma may help to stop increasing antibiotic resistance. The technology, known as ZinChel, was first developed in collaboration between the University of Tromsø (UiT) and the research group SYNFAS at the University of Oslo (UiO).

ZinChel has shown promising effects against a group of multi-resistant bacteria, which are increasingly widespread in many regions of the world, including Europe.

The bacteria, known as gram-negative, are equipped with a type of enzyme called “metallo-beta-lactamase”, which renders modern carbapenem antibiotics useless. These bacteria are on the World Health Organization’s list of the 12 most dangerous bacteria in the world, causing severe and often deadly infections.

Pål Rongved is a Professor at the University of Oslo with a PhD in chemistry. He is one of the inventors behind ZinChel and the founder and CEO of the start-up company Adjutec Pharma AS.

Adjutec Pharma AS has a strong momentum to develop the technology further together with our Norwegian partners and private investors. If we do this correctly, the results of this project can provide patients with vital treatment in the future and contribute to the establishment of a health industry that provides new jobs. We have an ethical and moral responsibility to bring the technology to market and patients as quickly as possible. There is no time to lose and we are on track”.

Creating value for patients and industry

The technology is not yet available to treat patients, because it is still in pre-clinical development. This means that it will need to be further tested on animals and humans to assess its safety and efficacy.

Adjutec Pharma has recently secured exclusive rights to the patents for the ZinChel technology and will raise more money to accelerate development of the drugs in collaboration with researchers at University of Oslo.

Adjutec Pharma has received $3 million in grants, including support from the Norwegian Research Council and Novo Nordisk. The company will raise $20 million in investments to reach Phase II clinical trials, including public and private funding.

Adjutec Pharma receives start-up services from Oslo Cancer Cluster (OCC) Incubator, who are partly financed by SIVA, a governmental enterprise facilitating a national infrastructure for innovation.

Bjørn Klem, general manager of Oslo Cancer Cluster Incubator, has provided important help in the establishment of Adjutec Pharma. Photo: Stig Jarnes

Bjørn Klem, general manager of OCC Incubator, said:

“OCC Incubator provided help and advice to the founders when establishing Adjutec Pharma, including finding competent people for the board. The OCC Incubator has negotiated the licensing agreement with the University of Oslo, which gives the company exclusive rights to commercialise the inventors’ patents. We also help the company with the development of a business strategy and financing through public funding programmes and private investors.”

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Photo: Vaccibody

Largest biotech agreement ever made in Norway

The team of Vaccibody celebrating their recent successes.

Our member Vaccibody signs multi-million-dollar agreement one week before the company is expected on the stock exchange.

The Norwegian cancer company Vaccibody has entered a worldwide license and collaboration agreement with GenentechRoche, to develop personalized cancer vaccines.

The agreement is worth up to 715 million dollars (approximately NOK 6,7 billion) in near term and milestones, in addition to low double-digit tiered royalties on sales of commercialized products. This makes it the largest agreement ever made in the Norwegian biotechnology sector. It is also the eighth largest biotechnology agreement made in Europe this year.

Michael Engsig, CEO of Vaccibody, said:

“We are very excited to have entered into this transformative agreement that marks the start of a new era for Vaccibody.”

“Genentech is widely recognized as one of the foremost leaders in leveraging the immune system to develop therapies for cancer and is a scientific pioneer within the neoantigen cancer vaccine space. They are therefore the partner of choice for the further development and commercialization of our innovative next-generation cancer vaccine platform for generating individualized therapies.”

This news comes about a week before Vaccibody is expected to be listed on Merkur Market, a part of the Oslo Stock Exchange.

A skyrocketing story

Vaccibody is dedicated to developing and discovering novel cancer treatments in the immunotherapy area. This is a type of treatment that boosts the body’s own immune system to recognise and destroy cancer cells.

The company was founded 13 years ago by Agnete Fredriksen, together with her mentors Professor Bjarne Bogen and his colleague Professor Inger Sandlie – two leading researchers in the Norwegian cancer innovation environment. Fredriksen is now President and Chief Scientific Officer of Vaccibody.

Over the last year, the company’s value has more than doubled several times and the company was valued at NOK 15,3 billion when markets closed on 1 October 2020.

Anders Tuv, Investment Director, Radforsk, and Chairman of the Board, Vaccibody. Photo: Radforsk

Anders Tuv, Investment Director, Radforsk, and Chairman of the Board, Vaccibody. Photo: Radforsk

Anders Tuv, Investment Director of Radforsk and Chairman of the Board of Directors for Vaccibody, has a solid track record of helping biotech companies develop in the oncology sphere. Tuv said:

“The deal with Genentech is a very significant endorsement of Vaccibody and a validation of the Vaccibody vaccine platform. Genentech, as one of the foremost leaders in leveraging the immune system to develop therapies for cancer, is the partner of choice to develop and commercialize individualized cancer vaccines. The deal will enable Vaccibody to accelerate and broaden the Company’s vaccine pipeline which we believe will unlock Vaccibody’s huge potential for patients and shareholders.

“This is a deal that generates substantial interest globally, and will put eyes on Norway as well.”

New strategy and focus

Vaccibody also presented a new strategy with expanded focus into research and development. The company wants to accelerate the development of existing drug candidates and detect new treatment options, based on the company’s technology.

The company’s technology platform will be extended to the discovery of other therapeutic areas and therapeutic methods, besides the present focus on cancer and infectious disease.

Promising cancer therapies

Vaccibody presently has two promising drug candidates. The first is a cancer vaccine against the human papilloma virus (HPV), which is currently being tested in a phase II trial on cervical cancer, in collaboration with Roche.

The second is an innovative personalized cancer vaccine, which has just been licenced to Genentech, and is specially designed for each individual cancer patient, independent of their cancer type.

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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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