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.

Professor Åslaug Helland, MD Ph.D. is the Principal Investigator of the NIPU clinical trial, which has demonstrated that malignant mesothelioma patients live longer when treated with the universal cancer vaccine UV1. Photo: Per Marius Didriksen, Oslo University Hospital

First demonstration of universal cancer vaccine

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New data shows 27% improved survival for malignant mesothelioma patients in the NIPU trial.

Positive results from the NIPU trial announced last night show the combination of a universal cancer vaccine and checkpoint inhibitors in patients with malignant mesothelioma reduces the risk of death by 27%.

“For patients with malignant mesothelioma, few treatment options are available after first-line chemotherapy. The NIPU study showed that patients receiving UV1 vaccination as add-on to nivolumab and ipilimumab experienced an increased objective response rate and a clinically meaningful prolonged survival. These encouraging results provide a foundation for advancing further clinical development with UV1 vaccination in mesothelioma patients,” said Principal Investigator of the NIPU clinical trial, Professor Åslaug Helland, MD Ph.D.

Åslaug Helland, Principal Investigator of the NIPU clinical trial. Photo: Per Marius Didriksen, Oslo University Hospital

The ‘gold standard’

This is the first demonstration of the efficacy and therapeutic impact of a universal cancer vaccine in a Phase II trial. The universal cancer vaccine is the lead product of the Norwegian biotech company Ultimovacs, which is developing novel immunotherapies against cancer. The vaccine is currently being tested in five Phase II trials on different cancer indications.

“We are thrilled to announce the highly advantageous results from the first randomized UV1 Phase II trial, marking a major milestone for Ultimovacs. Overall survival is the ‘gold standard’ in cancer treatment. We believe these data support further development in mesothelioma, and we are looking forward to discussing the results with the regulatory authorities,” said Carlos de Sousa, CEO of Ultimovacs.

Carlos de Sousa, CEO of Ultimovacs. Photo: Ultimovacs

Since malignant mesothelioma is a hard-to-treat cancer, the positive results from the NIPU trial give cause for optimism in the ongoing Ultimovacs’ trials for other cancer indications too, including malignant melanoma, head and neck cancer, ovarian cancer, and non-small cell lung cancer.

In October 2023, the FDA ranted Orphan Drug Designation for UV1 in the treatment of mesothelioma, but there is still a way to go before the drug reaches the market. The treatment has to be assessed in a Phase III trial and undergo regulatory approval before becoming widely available.

Improved survival and response rate

Oslo University Hospital leads the NIPU study with support from Ultimovacs and Bristol-Myers Squibb. It includes 118 patients from Norway, Sweden, Denmark, Spain and Australia. The patients are in second-line treatment, which means they already received chemotherapy without beneficial results and have no other treatment options.

The patients were divided into two randomized groups: 59 patients received the universal cancer vaccine in combination with checkpoint inhibitors, and the other group received only checkpoint inhibitors. Results show that patients who received the universal cancer vaccine had a prolonged survival rate and a significantly better objective response rate. This means the patients lived longer and more patients’ tumours shrunk than in the control arm. In addition, the treatment showed no added side effects.

“We want to extend our gratitude to the patients and their families, as well as the dedicated investigators and all our supporters whose invaluable contributions made this study possible,” Helland commented.

For more information, please read the press release from Ultimovacs or follow the company’s webcast on Mon, Oct 23 2023 at 14:30 (CET).

The post First demonstration of universal cancer vaccine first appeared on Oslo Cancer Cluster.