OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has accepted a new Meeting Request from the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) to review the Company's pharmacodynamic response biomarker data (the "OST-HER2 Biomarker Data") – patent pending. CDER's Biomarkers, EndpointS, and other Tools (BEST) resources is part of its Biomarker Qualification Program (BQP). This meeting is in addition to the forthcoming Type B Statistical Methods Meeting being scheduled with FDA's Center for Biologics Evaluation and Research (CBER) to review the 2.5-year overall survival data alongside the OST-HER2 Biomarker data developed from the Company's clinical development program for OST-HER2 in the prevention of delay of recurrence in fully resected, pulmonary metastatic osteosarcoma. CBER is the regulatory agency that will make the regulatory approval decision on OST-HER2.

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