Phase II year
2019
(last award dollars: 1718985143)
Phase II Amount
$1,498,027
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.
Public Health Relevance Statement: Project Terms: Non-Small-Cell Lung Carcinoma; nonsmall cell lung cancer; Nonsmall Cell Lung Carcinoma; Non-Small Cell Lung Cancer; NSCLC - Non-Small Cell Lung Cancer; NSCLC; Pharmaceutical Preparations; drug/agent; Pharmaceutic Preparations; Medication; Drugs; Modern Man; Human; immuno therapy; immune-based treatments; immune-based therapies; immune therapy; immune therapeutic strategy; immune therapeutic regimens; immune therapeutic interventions; immune therapeutic approach; immune drugs; Immunologically Directed Therapy; Immunotherapy; Methods; Patients; Sensitivity and Specificity; Standardization; Technology; Testing; Time; Work; Diagnostic tests; analytical method; base; Clinical; Phase; Biological; Solid Tumor; Solid Neoplasm; System; experience; novel; Sampling; response; Immunotherapeutic agent; immunotherapy agent; immunotherapeutics; immunologic preparation; immune-based therapeutics; Address; Cancer Diagnostics; Immune Targeting; Prediction of Response to Therapy; treatment response prediction; treatment prediction; therapy prediction; predict treatment response; predict therapy response; predict therapeutic response; Small Business Innovation Research Grant; Small Business Innovation Research; SBIR; follow-up; followup; followed up; follow up; active followup; Active Follow-up; resistance mechanism; resistant mechanism; Development; developmental; design; designing; chemotherapy; tumor; patient population; Biological Markers; biomarker; biologic marker; bio-markers; phase 2 study; phase II study; clinical predictors; response biomarker; response markers; Immune checkpoint inhibitor; immune check point inhibitor; Checkpoint inhibitor; Combination immunotherapy; dual immunotherapy; combinatorial immunotherapy; predictive test; predictive assay; patient response; responsive patient; PD-1/PD-L1; PD1/PDL1; PD1/PD-L1; PD-1/PDL1
