Anette Weyergang, CEO of Rab Diagnostics. Photo: Sofia Linden / Oslo Cancer Cluster

A tool for targeted chemotherapy

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A new test aims to identify which cancer patients benefit from being treated with antibody drug conjugates.

The Norwegian start-up company Rab Diagnostics is developing a tool to improve targeted chemotherapy. The test will identify which cancer patients can benefit from antibody-drug conjugates (ADCs).

“There is an unmet clinical need for better tools to stratify cancer patients as responders or non-responders to ADC treatment,” says Anette Weyergang, co-founder and CEO of Rab Diagnostics, a spin-out from Oslo Universiy Hospital admitted to Oslo Cancer Cluster Incubator (OCCI).

Finding the right patients

ADCs represent a prominent class of anticancer therapeutics that bring hope to incurable cancers. Since the first ADC was approved in 2000 by the US Food and Drug Administration (FDA), 11 more ADCs have received market approval worldwide, 8 of these since mid-2019. Furthermore, over 100 ADCs are currently being investigated in clinical trials. Thus, these anti-cancer drugs are leading a new era of targeted cancer therapy.

“These drugs are targeted chemotherapy, consisting of an antibody linked to a chemotherapeutic drug. The antibody is designed to find the cancer cell while the chemotherapy shall kill it. In this way, ADCs are constructed to bring the chemotherapy to the cancer cells and leave healthy cells unharmed. However, the full clinical potential of these targeted drugs remains to be realised as there is a substantial difference in treatment efficacy between patients, causing unsatisfactory objective response rates (ORRs) down to only 25%. The problem is, we do not know which patients to treat,” says Weyergang.

Founded on Norwegian research

This is where Rab Diagnostics comes in. The company was founded in August 2023 by three researchers at Oslo University Hospital after studies showed that RabGTPases, a family of proteins, can be used as biomarkers to predict if ADCs will work.

“We have made key achievements showing that our technology is valid for different ADCs and cancer indications, and we have shown that our biomarkers can be evaluated on both protein- and RNA levels, which provides flexibility for our products in the pipeline. They have also verified our technology in three independent clinical cohorts,” says Weyergang.

Some of these achievements were published in Nature Communications in 2021 and set the ground for a patent family. The company has developed a strategy to commercialise its first product and generated a business plan to reach this goal. In July 2024, Rab Diagnostics also received the “Seal of Excellence” from the European Innovation Council.

An emerging market opportunity

In the age of personalised cancer medicine, many patient stratification tools and diagnostics tests are entering the oncology market. However, the competition for biomarkers in the ADC space is still relatively low.

“Our competitors consist of companies developing stand-alone diagnostics and companion diagnostics. None of these offers a solution where RabGTPases are used to predict ADC treatment decisions, thus we have no direct competitors,” says Weyergang.

Rab Diagnostics aims to pioneer a new proprietary class of biomarkers, that will unlock the full potential of the rapidly evolving class of ADCs. The company has already received interest from the oncology milieu and had discussions with industry experts from pharma and healthcare companies who have confirmed interest in the technology.

For several cancer indications

The company’s first product is a diagnostic test for breast cancer patients legible for an ADC called T-DM1. As this product is focused on one ADC in a subset of breast cancer, the commercial opportunity is limited.

“Launching this first product is, however, a strategic move as it serves the important task of getting traction for our other diagnostic tests in the pipeline covering several ADCs and cancer indications with a tremendous commercial opportunity. Utilising RabGTPases as ADC biomarkers offers a new way of thinking when it comes to finding the right patient,” says Weyergang.

Rab Diagnostics’ strategy includes fast commercialisation of its first product to educate the market to use Rab proteins to guide ADC treatment decisions.

The story behind Rab

Rab Diagnostics was initiated as an innovation project at Oslo University Hospital and admitted to the SPARK Norway innovation program, where it was awarded the Vaccibody Innovation Award 2023. SPARK provided mentoring and financial support to engage with pharma representatives and investors and supported the first market analysis. The program also provided entrepreneurial education of high value for further development towards commercialisation.

“The innovation project was then admitted to the Oslo Cancer Cluster Incubator who gave mentoring and guidance to set up the company together with financial support from Radforsk. Oslo Cancer Cluster and its Incubator have continuously supported Rab Diagnostics with advice and have used their network to promote the company and connect them with key stakeholders in the field,” says Weyergang.

 

 

The series The Start-up Spotlight and The Scale-up Spotlight are produced in collaboration between the Norwegian health clusters: Norway Health Tech, Oslo Cancer Cluster, The Norwegian Smart Care Cluster, The Life Science Cluster and Biotech North. The initiative was funded by Viken fylkeskommune. Please contact us, if you wish to have your company to be featured.

The post A tool for targeted chemotherapy first appeared on Oslo Cancer Cluster.

Glenn Gundersen, Exact Sciences, Norway.

Gene profiling test for breast cancer approved

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A gene profiling test that predicts which breast cancer patients benefit from chemotherapy will now be adopted in Norwegian healthcare services.

After more than three years of processes in Nye Metoder (the national system of managed introduction of new methods in the specialist health care service in Norway), a gene profiling test for breast cancer patients was authorised on Monday morning. The test, offered by Oslo Cancer Cluster member Exact Sciences, can identify which breast cancer patients benefit from chemotherapy. The test was however only approved for breast cancer patients who are lymph node positive.

“We are surprised that we didn’t get approval for the largest group of patients, those who are lymph node negative. The Decision Forum considers that this group is already covered by Prosigna, even though Oncotype DX has very good documentation and is both cost-effective and cost-saving. So now Prosigna (which is not predictive for the use of chemotherapy) is given monopoly on a large group of breast cancer patients. This is incomprehensible across several countries. It seems almost like a misunderstanding. Normally competition is desirable,” said Glenn Gundersen, Exact Sciences, Norway.

Personalised treatment

There are about 4 000 new breast cancer cases in Norway every year and the number increases. Most patients receive chemotherapy after surgery, which can cause serious side effects, but not everyone has an added benefit from this treatment.

“This is about personalised treatment. Oncotype DX is a CE-marked gene profile test, consisting of 16 cancer-related genes and 5 reference genes. The genes have been selected because they have a prognostic and predictive value. This means the test can predict the potential benefit of chemotherapy for each patient’s tumour. These properties have been clinically validated in well-reputed large prospective randomised clinical trials.

“This represents an important advance in cancer precision medicine. We can more than halve the number of women receiving chemotherapy today. That means several hundreds, if not thousands, can be spared of chemotherapy side effects. It will have a dramatic impact if it is offered to lymph node negative patients as well,” said Gundersen.

A long process

Exact Sciences first sent the application to the Ordering Forum in June 2021. More than two years later, the Norwegian Institute of Public Health finished the health technology assessment of the product. However, it would take the Decision Forum another 10 months to decide on whether to approve the test for use in Norwegian cancer clinics.

“This is a no-brainer. Oncotype DX fulfils the three priority criteria: benefit and effect, use of resources, and disease severity. The health technology assessment states that between NOK 15 000 and 50 000 is saved for every patient, and for thousands of patients, it quickly adds up. Based on its strong documentation and value for the patient and the health care system, Oncotype DX should have qualified for a faster approval process,” adds Gundersen.

Based on UK data, an external evaluation group appointed by NICE (UK) reported that Oncotype DX could result in 594 fewer women having chemotherapy per 1 000 tested among N1 patients (patients with cancer spread to 1-3 lymph nodes in the axilla). The reduction for other gene profiling tests (Prosigna, EndoPredict) was 40. Oncotype DX is already in use in about 100 countries and has been tested in more than 1,8 million patients.

Privacy issues

With the advent of personalised cancer medicine, more gene profile tests are entering the market. This sparks legal and ethical questions about sharing Norwegian patients’ tumour tissue and health data with foreign commercial partners.

Gundersen explains: “Exact Sciences recognizes the sensitive nature of health data and the duty to guard its confidentiality. We pledge to maintain the highest level of privacy and security for our patients’ trusted information. Exact Sciences leverages advanced security expertise to safeguard sensitive medical data. We adhere to stringent legal frameworks like Data Processing Agreements (DPA) and Business Associate Agreements (BAA). These compacts are shaped by the mandates of the General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA), respectively, ensuring protection through compliance.

“Exact Sciences does not sell health information. We collect and use personal data for the singular purpose of performing laboratory tests as permitted by contract.

“The tumour specimens are sent by medical express courier to our laboratory in California, where a tiny fraction of the sample is used. In 7-10 days, the results are returned to the treating physician’s password-secured web portal and the remaining sample is returned. This means the Norwegian pathology departments don’t need to do any extra work, in fact, it may liberate capacity since they do not need to perform other local gene profiling analyses.”

 

The post Gene profiling test for breast cancer approved first appeared on Oslo Cancer Cluster.

Christian Jonasson, Research Director, and Steinar Thoresen, Medical Director, at NordicRWE are pleased to present the company's pioneering study into lung cancer immunotherapies. Photo: NordicRWE

NordicRWE reveals lung cancer immunotherapy study

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Three leading immunotherapy drugs against lung cancer demonstrated similar overall survival in a recent comparative study from NordicRWE.

The Norwegian start-up company NordicRWE has compared the effectiveness of three immunotherapies in second line treatment of advanced non-small cell lung cancer. The results indicate that the three immunotherapy drugs were equally effective in terms of overall survival.

“Lung cancer has historically been associated with a poor prognosis; however, new targeted therapies have significantly improved outcomes for these patients. Immunotherapies are among the new drugs introduced in Norway in recent years. The selection of the most appropriate drug for this specific indication has sparked considerable debate, particularly regarding efficacy and cost-effectiveness. We aimed to use our national registers and advanced statistical methods to answer these questions. We know that our national registers are of high and unique quality, well-suited to addressing these questions,” commented Steinar Thoresen, Medical Director at NordicRWE.

Using Norwegian health data

NordicRWE obtained extensive data from Norwegian health registries and applied advanced epidemiological methods and statistical analyses to emulate populations included in randomised clinical trials (RCTs).

“To introduce a cancer drug to the market, it is mandatory to provide evidence that the intervention is effective compared to current standard-of-care, but not to drugs being in the same drug class. As a result, head-to-head RCTs comparing the best treatments for the same condition are seldom conducted due to various reasons, such as cost, time and associated risk. This lack of comparative evidence from RCTs leads to an important evidence gap that we see can be replaced with using real-world data and advanced epidemiological research methods,” said Christian Jonasson, Research Director at NordicRWE.

“The study can be seen as a follow-up of the respective clinical trials in the real-world setting. Both patients and oncologists must ensure that the treatment administered is the most effective currently available on the market. To our knowledge, this is one of the first observational research studies that have assessed the comparative effectiveness of immunotherapies on lung cancer survival,” Thoresen added.

RWE in drug development

NordicRWE is actively engaged in real-world evidence, focusing on key areas such as the development of external control arms for clinical trials, comparative effectiveness and safety studies, and evaluating the representativeness of clinical trial populations and outcomes in real-world clinical practice.

“Real-world evidence is increasingly important in drug development and evidence generation for drug therapies. With this study, we hope to showcase the exceptional quality of Norwegian health data and demonstrate NordicRWE’s expertise in conducting rigorous epidemiological research studies. This is important with regards to establishing our solutions and services with both the global pharmaceutical industry and governmental bodies,” said Jonasson.

The current study was made possible due to a grant from The Norwegian Research Council.

The results will be presented as an abstract and oral presentation at the International Conference for Pharmacoepidemiology (ICPE) congress in Berlin on 27 August 2024. The full-length article is currently also under review with a leading journal in the field.

 

For more information, please contact: 

Steinar Thoresen, MD, Ph.D. Medical Director

Phone: +47 907 83 736

Email: st@nordicrwe.com

 

Christian Jonasson, MSc. Pharm. Ph.D. Research Director

Phone: +47 909 36 941

Email: cj@nordicrwe.com

The post NordicRWE reveals lung cancer immunotherapy study first appeared on Oslo Cancer Cluster.

Oslo Science Hub will provide an inviting and inclusive area for everyone on the Radium Hospital Campus and contribute to faster development of new cancer treatments. Illustration: Nordic Office of Architecture

New plans for the Radium Hospital Campus

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Article edit: On Tuesday 20 August 2024, an agreement was signed between Oslo City Council and Oslo Science Hub to sell the lots necessary for the building.

The planned buildings will transform the Oslo Montebello area into an international power centre for cancer research.

The drawings for Oslo Science Hub, the next expansion phase of Oslo Cancer Cluster Innovation Park, have been sent to Oslo City for approval and were recently presented at a meeting during Arendalsuka.

“Our vision is to create a vital and inclusive environment where researchers, entrepreneurs and companies at the Radium Hospital Campus can meet and collaborate to contribute to developing better cancer treatments,” stated Thomas London, CEO of Oslo Science Hub.

Thomas London, CEO of Oslo Science Hub, wants to contribute to developing new cancer treatments and offer a better environment for cancer patients and next of kin at the Radium Hospital. Photo: Sofia Linden

The new building will be 40 000 square metres, accommodate up to 2 000 employees, and offer state-of-the-art laboratories, complementary hospital services, biobank facilities and offices. There will be a mixture of tenants from the public and private sectors in health, oncology and biotechnology. The vision includes creating a “miniature village” with town squares, cafés, restaurants and shops to facilitate interactions between employees, patients and visitors.

A European power centre

“The Radium Hospital Campus is a European power centre for research, clinical treatment and innovation. We have a burning desire to develop the campus into a good place to do pharmaceutical research and development, to attract international key players, which are currently the missing link in the area,” commented Jónas Einarsson, founder of Oslo Cancer Cluster and CEO of Radforsk investment fund.

Oslo Science Hub will be built next to Oslo Cancer Cluster Innovation Park, the Institute for Cancer Research and Oslo University Hospital. Illustration: Nordic Office of Architecture

The Radium Hospital Campus already includes Oslo University Hospital, a Comprehensive Cancer Centre focused on innovation with its newly built clinic and proton centres. The area also encompasses the Institute for Cancer Research, which boasts solid research groups performing world-class research in several oncology areas.

Right next door is Oslo Cancer Cluster Innovation Park housing a mixture of public and private stakeholders, such as the Cancer Registry of Norway, Oslo University Hospital, and the Oslo Cancer Cluster Incubator with different start-ups and established companies.

A fourth building block is currently under construction, which will accommodate a restaurant, a cafeteria, a training centre, the non-profit organisations Active Against Cancer and Youth Cancer, and the international life science company Thermo Fisher Scientific.

Lack of space

“The area needs this type of building. We have been there for 30 years and are missing areas for expansion, special laboratories, and cafés and restaurants,” commented Geir Hetland, Chief Financial Officer of Thermo Fisher Scientific.

Thermo Fisher Scientific Norway was based on the Norwegian invention “Ugelstad-kulene” (later known as Dynabeads). The technology was developed in close collaboration with the Radium Hospital and today it is used in 5 billion diagnostic tests every year. Thermo Fisher Scientific need space to continue the company’s research and development in Norway.

Oslo Science Hub will bring laboratories, office spaces, biobank facilities and more, which will contribute to attracting international key players in research and development. Illustration: Nordic Office of Architecture

“We have spent an unnecessary amount of time through the years handling the lack of space for our companies. We have needs from start-ups, established companies and the hospital. I am happy we have built this ecosystem with all its positive dynamics and see that it is essential for start-ups to collaborate with international companies. So there needs to be further investments both on a national and local level for the health industry to succeed,” commented Ketil Widerberg, general manager of Oslo Cancer Cluster.

More than a hospital

For the patients, next of kin and health workers, these facilities are also sorely needed, since there are currently few places to meet, exercise, enjoy food or venture outdoors.

Sigbjørn Smeland, director of the Norwegian Radium Hospital, commented:

“My predecessor Jan Vincent Johannessen coined the term ‘more than a hospital’. This is clearly an extension of his work and shows that building culture and creating value over time releases good forces. We will offer the patient more than treatment for their cancer disease. This building is incredibly valuable in the totality we offer as a Comprehensive Cancer Centre.”

The new building will offer open and airy spaces for employees, visitors, patients and next of kin to meet and interact. Illustration: Nordic Office of Architecture

Ingrid Stenstadvold Ross, general secretary of the Norwegian Cancer Society, added:

“The most important thing is that the Radium Hospital is a spearhead in cancer care, that patients can get the best treatments available. The health services are also under pressure, meaning it is more important than ever to attract and keep skillful health workers. These facilities will help to do both these things.”

From words to action

Leader of the Oslo City Council Eirik Lae Solberg (The Conservative Party of Norway) made the campaign promise last year to ensure the sale of the real estate needed to build Oslo Science Hub.

“This is not a regular real estate issue. We need to prioritise this. We have a milieu that contributes to saving lives. From Oslo’s point of view, it is fantastic to have this industry. We have to support it if we want to be competitive in the future as a capital city,” Lae Solberg said.

Solveig Vitanza (the Labour Party of Norway), parliamentary representative, and Eirik Lae Solberg (the Conservative Party of Norway), leader of the Oslo City Council, promised their support to the development of the Radium Hospital Campus. Photo: Sofia Linden

Secretary General of the Ministry of Health and Care Services Cathrine Lofthus was also excited to see the plans taking concrete shape:

“I believe we need physical meeting places. We are not good enough at collaborating with the industry, but we hope to be better. This is exactly what we are talking about when we refer to the Roadmap for the Health Industry and Health as an Export Priority.”

Parliamentary representative Solveig Vitanza (Labour Party of Norway) expressed her ambition to go from words to action:

“We must facilitate the whole value chain: testing and piloting, clinical studies, clusters, health technology and data. We are in a very special time, with a recent pandemic and a geopolitical situation, which makes health a higher priority than ever.”

Watch the meeting here (in Norwegian):

Oslo Science Hub facts

  • Planned to be finished: 2030
  • Brutto area: 40 000 sqm
  • Potentially 2000 employees
  • State-of-the-art laboratories, complementary hospital services, biobank and offices
  • Mix of tenants similar to Oslo Cancer Cluster Innovation Park: public and private actors in oncology and biotechnology, especially international pharmaceutical industry
  • Open areas for the public, such as shops, restaurants, cafes and roof terraces

The Radium Hospital Campus facts

  • One of Europe’s largest campuses for cancer research and treatment
  • Consists of the new Radium Hospital, which opens in September 2024, the Institute for Cancer Research and Oslo Cancer Cluster Innovation Park and Incubator (OCCI)
  • Total building mass is 105 000 sqm
  • About 3 500 people work on the campus in different enterprises, while Ullern Upper Secondary School, which is an integrated part of OCCI, has 970 students
  • OCCI expands with 12 000 sqm that will be finished in 2025, which will include Thermo Fisher Scientific with several research departments, Active Against Cancer and some of the companies from OCC Incubator
  • A mix of public and private institutions that collaborate across organisations
  • Ullern Upper Secondary School have a school collaboration with other enterprises on campus, which includes placements and mentorships
  • Oslo Cancer Cluster Incubator with 16 start-up companies
  • A part of Oslo Science City, which is Norway’s first innovation district and an important part of Oslo City’s investment as a business capital

The post New plans for the Radium Hospital Campus first appeared on Oslo Cancer Cluster.