Accure Health Inc

Automated Plasma EV-PDL1 Analysis for Cancer Immunotherapy - Abstract Challenges. There Are Over 4000 Clinical Trials Testing ANTI-PD1/PD-L1 Immune Checkpoint Inhibitors (ici), Either Alone or in Combination With Other Therapies. While Many Patients Benefit, the Vast Amount Do Not, All at a Considerable Cost. the Most Validated and Fda-approved Biomarker to Guide Patient Selection Is Through Immunohistochemical (IHC) Staining and Scoring of Tissue Biopsies for PD-L1 (e.g. Tumor Proportion Score, TPS). Unfortunately, TPS Is an Imperfect Biomarker: I) It Requires Surgical or Image Guided Tissue Biopsy Which Is Sometimes Difficult to Perform; Ii) the Site and Timing of Tissue Acquisition and Staining Protocols Can Influence the Accuracy of TPS; Iii) Ihc Takes Days to Process, Delaying Treatment; Iv) Many Tps-positive Patients Do Not Respond to Ici Treatment; and V) TPS Can Change During Chemo, Targeted and Ici Therapies. Phase I Goals. Accure Health Proposes to Explore an Alternative Approach: Circulating PD-L1 Biomarker Assay Based on Technology-integrated Magneto-electronic Sensing (TIMES) of Extracellular Vesicles (evs). Supported by Promising Clinical Data, We Hypothesize That Circulating Ev Analysis Integrating PD-L1 Expression From Primary and Metastatic Lesions Can Be a More Comprehensive Marker. We Propose Two Specific Aims. Aim 1. Develop an Automated Times Assay to Analyze Pan EV-PDL1 and Cell Type-specific EV-PDL1. Aim 2. Establish Times EV-PDL1 Scores and Correlate With TPS. We Envision the Automated Times EV-PDL1 Assay and Integrated Scores Can Be Utilized in Clinical Trials Testing ANTI-PD1/PD-L1 Mono- or Combination Therapies. It Can Provide a Faster and More Reliable Solution for Evaluating Treatment Response, and Help Accelerate Regulatory Decision-making.