Announcement • 23h
OS Therapies Incorporated, Annual General Meeting, Sep 09, 2026 OS Therapies Incorporated, Annual General Meeting, Sep 09, 2026. Location: sep26, United States Announcement • Jul 09
OS Therapies Accepts New FDA Meeting Request To Review Biomarker Data As Part Of BEST Program OS Therapies Inc. 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. Alignment between CBER and CDER on the use of the OST-HER2 Biomarker Data is an important step in preparation for formal evaluation of the pending final 3-year overall survival data that will be included in the Company's Biologics License Application (BLA) submission under the Accelerated Approval Program expected in early Fall 2026. CBER has invited the Company to a Type B Pre-BLA meeting following the Company's January 2026 submission of the Non-Clinical and Chemistry, Manufacturing and Controls (CMC) BLA modules in the first quarter of 2026. The Company announced final 2-year overall survival data on October 10, 2025. The Company expects to announce interim 3-year overall survival data in the summer of 2026. OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA, and ODD, FTD and ATMP from the EMA and MHRA. Under the RPDD FDA program, if the Company receives a BLA in the United States, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The Company's Commissioner's National Priority Review Voucher (CNPV) letter of intent was accepted by FDA, with a final decision expected following full submission of the OST-HER2 BLA. The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma by year-end 2026 in the U.S., in addition to Conditional Marketing Authorisation Applications in Europe, the U.K. and Australia. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 is designed to target two mutated extracellular epitopes and one mutated intracellular epitope of the HER2 oncogene, requiring only one of these three epitopes to be present in a tumor (or micro-metastasis) to trigger the desired immune response. OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and has received ODD, FTD and Advanced Therapy Medicinal Products (ATMP) from the European Medicines Agency. The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma, demonstrating clinically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study and the overall survival (OS) secondary endpoint. The Company is seeking a Biologics License Application (BLA) from the U.S. FDA for OST-HER2 in osteosarcoma in 2026 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. The Company also anticipates receiving Conditional Marketing Authorisation Applications from the U.K.'s Medicines and Healthcare products Regulatory Agency and the EMA for OST-HER2 in 2026. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has previously been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. The Company has also completed dosing in a Phase 1 study of OST-504 for castration-resistant prostate cancer. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. Announcement • Jul 03
OS Therapies, Inc. Announces Board Changes OS Therapies Inc. announced that it had appointed Dr. Craig Eagle to the Company's Board of Directors. Dr. Eagle currently serves as the Company's Chief Medical Advisor. Dr. Eagle most recently served as Guardant Health's Chief Medical Officer. Prior to joining Guardant Health, Dr. Eagle served as Vice President of Medical Affairs Oncology for Genentech, where he oversaw the medical programs across the oncology portfolio and developed innovative cancer trials and strategies in personalized health care. Prior to Genentech, Dr. Eagle held several leadership roles at Pfizer, including oncology business lead for the United Kingdom and Canada, global lead for Oncology Strategic Alliances and Partnerships, and global head of the Oncology Therapeutic Area Global Medical and Outcomes Group, where he oversaw the U.S. oncology business. Dr. Eagle attended medical school at the University of New South Wales in Sydney, Australia and received his general internist training at Royal North Shore Hospital in Sydney. OS Therapies Inc. also announced that Karim Galzahr would continue as a member of the Company's advisory board. Eagle currently serves as the Company's Chief Medical Advisor. The Company also thanks Karim Galzahr for his service to the Board of Directors and will continue as a member of the Company's advisory board. 
