(Wayne, PA)- Genome Profiling (www.genomeprofiling.com) completed a series of collaborative retrospective studies with a top ten biopharma immuno-oncology translational research team that resulted in the discovery and blind validation of a novel epigenetic biomarker (EpiMarker) that successfully stratified responder vs non-responder solid tumor cancer patients that had participated in a Phase 2 trial of the biopharma’s checkpoint inhibitor based therapy. Despite the trial including all-comer patients with extensive prior treatments and two different tumor histopathologies, the results demonstrated that if the GenPro EpiMarker had been used for patient selection in the original trial, the response rate would have increased from approximately 30% to 50%.
Genome Profiling’s Co-founder and Chief Scientific Officer, Adam Marsh expressed, “We and our biopharma team counterparts are excited by this outcome from whole blood samples. The unique and definitive phenotypic EpiMarker is completely a consequence of the GenPro EpiMarker Platform’s unique ability to decode the sentinel power of the immune system into clinically actionable EpiMarkers that when matched to an I-O treatment (or any drug for most any disease) can be used as a blood test to stratify responder vs non-responders to that drug independently of circulating tumor DNA or cell free DNA.”
Mark Anderson, Genome Profiling’s Vice President EpiMarker Solutions and former senior cancer biology leader for a big pharma commented, “In addition to the primary result based on EpiMarkers that related directly to disease response, GenPro was able to find methylation changes in circulating immune cells that were strongly correlated with tumor PD-L1 expression. These liquid biopsy biomarkers were substantially better predictors of overall survival than PD-L1 IHC results for this indication and treatment regimen.”
Following these initial successes Genome Profiling’s capabilities are now being applied to a Phase 3 trial where the biopharma collaborator is testing an immunotherapy regimen in a second solid tumor indication. The goal is to discover a novel phenotypic blood-based EpiMarker and precision test that stratifies responders vs non-responders. That test could then be developed into a blood-based CDx for their IO-drug. This biopharma company is among the top 10 global biopharma companies with a significant commitment to immuno-oncology therapies.
Genome Profiling is a functional genomics company leading the decoding of the sentinel power of the immune system’s unique epigenetic responses to the stressors of disease into a new class of clinically actionable biomarkers. These immune-system derived epigenetic biomarkers are called EpiMarkers. Novel EpiMarkers are translated into transformational drug response prediction and diagnostic blood tests that accelerate the promise of precision health in Oncology/Immuno-Oncology and across the spectrum of non-gene-mutation-driven diseases. Uniquely distinguishing Genome Profiling is its proprietary, cloud-based, machine-learning-enabled bioinformatics platform called the EpiMarker Platform for rapidly profiling, discovering and validating each unique genome-wide immuno-epigenetic response to a disease into an in silico EpiMarker. These EpiMarkers can, for example, be matched to a drug to phenotypically stratify patients who will be responders vs non-responders to the drug from a simple blood test to improve patient selection into clinical trials and for development into a CDx for the drug. Likewise, novel EpiMarkers and their derivative tests are proving to be powerful diagnostic tools, all elucidating new clinically actionable biology beyond what current gene mutation biomarkers and techniques can achieve.
Jeb Connor, Chairman, CEO and Co-Founder