Bio-Me receives 2 million Euro in public funding

Bio-Me receives 2 million Euro in public funding to develop microbiome biomarker test identifying responders to cancer immunotherapy

OSLO, Norway, April 21st 2020 – Bio-Me today announced it has received a total of 2 million Euro in grants and public support from The Research Council of Norway to develop a companion diagnostic test for immune checkpoint inhibitor (ICI) cancer treatments. It is well known that the gut microbiome influences the efficacy of ICI treatments. Bio-Me will use its breakthrough PMP™ – Precision Microbiome Profiling technology – to develop a microbiome-based test that can identify responders to ICI. Test development involves key Norwegian and International partners and a close collaboration between leading clinical experts and academic researchers in the field. The project will run to the end of 2023 and diagnostic test is set to be available shortly after that and is anticipated to significantly improve patient outcomes.

Nowhere is the challenge of improving patient outcomes more apparent than in the promising recent development of immune checkpoint inhibitors (ICI) for cancer therapy. This new class of drug is highly effective for patients who respond as it strengthens the individual’s own immune response to fight the cancer. When the treatment works optimally it avoids the dramatic side-effects associated with traditional radio and chemotherapies. The challenge so far has been that treatment response and side-effects vary significantly, with only 20-30% of patients responding optimally to treatment. With the establishment of the microbiome as a determining factor in ICI treatment outcome, the search is now on for microbiome-based patient stratification tests and therapeutics that can improve the response rate to ICI treatment.

Principal clinician Dr. Odd Terje Brustugun of the Vestre Viken Hospital Trust said: “We believe that the gut microbiome can profoundly impact the efficacy of modern cancer immunotherapy, and this nationwide clinical study will help to unravel the connection. By using the PMP™ platform from Bio-Me, we expect that the results from the clinical trial will be readily transferrable to real-world situations in clinical settings and provide direct benefit to the patients as well as potentially contribute to health cost savings.

The microbiome is a burgeoning target for the pharmaceutical field. Several of the large drug development companies now include microbiome-modifying agents in their pipelines. There is hope that in the future microbiome-modifying agents can be used to increase patient responsiveness to ICI treatment. Companion diagnostic tests will be required for the development of these prospective treatments.
Dr. Morten L. Isaksen, CEO of Bio-Me commented, “By having access to large cohorts of patients from different studies, in combination with proprietary panels of target bacteria, Bio-Me will be in a unique position to further the understanding regarding which bacteria are associated with responders and non-responders to ICI treatment. These results, together with the extensive array of health parameters available through the Norwegian health care system, will enable us to design an optimized test for detecting both bacteria and key bacterial enzymatic functions that contribute to the ICI response. The data collected will be used to build and test advanced models for predicting patient outcome. As a result of the study we plan to deliver the first effective microbiome-based precision medicine approach to ICI cancer therapy. Used in combination with microbiome-modifying agents – of which several are in development – it has the potential to lift patient response rates from 30% to over 80%. We are currently evaluating potential partners who have suitable microbiome modifying agents for this purpose.

All major hospitals treating lung cancer in Norway are involved in the project which will investigate over 1000 patients diagnosed with advanced lung cancer. The study is a collaboration between Bio-Me and R&D partners Vestre Viken Hospital Trust, NTNU/HUNT4 Biobank, and Thermo Fisher Scientific.