SBIR Topic 354: A Novel Predictive Test for Response to Combination Immunotherapies for Patients with non-small cell lung cancer (NSCLC)

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In the proposed Phase II study, we will further develop our PathMAP® Immunotherapy test to address an unmet clinical need within the NSCLC patient population. We hope to create a test that is able to accurately predict clinical response to PD-1/PD-L1 targeted immune checkpoint inhibitors alone and in combination with chemotherapies. Our development work in Phase II will be based on our initial work performed in Phase I and our extensive experience designing and developing PathMAP tests. The PathMAP Immunotherapy test will predict therapeutic response by eliciting and categorizing NSCLC samples’ dynamic biomarker responses to biologically-relevant modulators and chemotherapy agents. In this way, we will be able to characterize each tumor’s intrinsic resistance mechanisms, and how these mechanisms impact key biomarker expression capabilities. This ex vivo approach will be made possible by the SnapPath® Cancer Diagnostics System, which automates and standardizes live solid tumor processing and functional interrogation, to enable highly predictive tests in patients with solid tumors. To our knowledge, the PathMAP Immunotherapy test will represent the first time ex vivo technology has been used in a diagnostic test to predict patient responses to any immunotherapeutic drug.