News from external sources

Erna Solberg visits PCI Biotech

PDT/PCI application grant 2021

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

 

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 microbial resistance at Oslo Life Science Week 2017. Photo: UiO/Terje Heiestad

Norwegian invention to fight antibiotic resistance

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 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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The team of Vaccibody celebrating their recent successes.

Largest biotech agreement ever made in Norway

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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OncoInvent

Clinical studies – important for Norwegian companies

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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