On July 3, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration ("FDA") to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Press release, OS Therapies, JUL 3, 2025, View Source [SID1234654242]). The Company expects the meeting to occur in the third quarter of 2025. The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access.
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The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application ("BLA") submission for OST-HER2. The Rolling Review process means that a company can submit completed sections of its Biologic License Application (BLA) for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. This can contribute to augmented interactions with FDA and potentially an expedited BLA approval timeline.
OST-HER2 has received FDA Orphan Disease Designation (ODD), Fast Track and Rare Pediatric Disease Designation (RPDD) from FDA. Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale, valued at $160 million, occurred in June 2025.
OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The trailer is available here and the movie is available via streaming on PBS’ website.
The most recent data regarding the OST-HER2 canine osteosarcoma program is available at this link. The Company has formed subsidiary OS Animal Health to advance the canine osteosarcoma program.