Igf::ot::igf Sbir Phase I Topic 354-a Novel Predictive Test for Response to Immunotherapies for Patients With Non-small Cell Lung Cancer; Pop 09/19/16-06/18/17

Period of Performance: 09/19/2016 - 06/18/2017


Phase 1 SBIR

Recipient Firm

Biomarker Strategies, LLC
Derwood, MD 20855
Principal Investigator


Significant advances in the development of immune checkpoint inhibitors have yielded durable responses in Non-Small Cell Lung Cancer (NSCLC), the most common form of lung cancer. Unfortunately, many patients who might ultimately respond to this important therapy may not receive it because they are considered biomarker negative by today?s Companion Diagnostic (CDx) tests. To address this critical unmet need, BioMarker Strategies proposes to develop a CDx test using the SnapPath Cancer Diagnostics System to predict patient responses to PD-1/PD-L1 targeted immune checkpoint inhibitors. Unlike traditional indirect approaches that measure static biomarkers in dead tissue, SnapPath enables treatment of a patient?s live tumor cell biopsy with different modulators and measures their functional responses to predict an individual patient?s response to therapy. This unique approach enables NSCLC tumors to be measured for their ultimate PD-L1 expression potential, not just their expression at time of biopsy. Ultimately, the development of this SnapPath CDx test will yield highly predictive results for NSCLC patients, in particular addressing biomarker negative patients who could otherwise be excluded from the benefit of these very important therapies.