Bio-Me has received a total of 2 million EUR in grants and public support from the Norwegian Research Council to develop a companion diagnostic test for immune checkpoint inhibitor (ICI) cancer treatments.
Bio-Me will use its 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 clinical experts and academic researchers in the field.
“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,” says Dr. Morten L. Isaksen, CEO of Bio-Me.
Investigate over 1000 patients diagnosed with advanced lung cancer
The project will run to the end of 2023 and diagnostic test is set to be available shortly after that.
“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,” says Principal clinician Dr. Odd Terje Burstugun of the Vestre Viken Hospital Trust.
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.