On May 7, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported the issuance of United States Patent #12,230,738 protecting proprietary commercial manufacturing methods for the Company’s listeria monocytogenes (Lm) cancer immunotherapy platform technology into 2040 (Press release, OS Therapies, MAY 7, 2025, View Source [SID1234652676]). The Company is seeking to gain FDA approval for lead asset OST-HER2 in the treatment of pediatric recurrent, fully-resected, lung metastatic osteosarcoma by the end of 2025. Phase 3-stage OST-AXIL for HPV, Phase 2-stage OST-503 for NSCLC & GBM, Phase 1-stage OST-504 for Prostate cancer, 8 pre-clinical stage immunotherapy candidates are also protected under this patent. The patent also covers OST-HER2’s use in canine osteosarcoma.
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"The issuance of this patent covering commercial manufacturing for the entire listeria monocytogenes platform breathes new life into our pipeline, giving us the exclusive ability to develop this exciting field of cancer immunotherapy," said Paul Romness, CEO of OS Therapies. "Potential FDA approval of OST-HER2 in Osteosarcoma would bring a Priority Review Voucher valued at least $150 million. This non-dilutive capital will allow us to expand OST-HER2 use into metastatic & frontline osteosarcoma, and other HER2 positive cancers. The issuance of this patent resets the clock in terms of creating value from the over $250 million previously invested in the platform. Additionally, this positions OS Therapies to develop three (3) clinical and eight (8) pre-clinical assets that could improve the standard of care in a variety of cancers."
OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell immediately. The most recent PRV sale valued at $150 million occurred in February 2025.
The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following chemotherapy. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million.
Human and Canine OST-HER2 patients are featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie focuses on canine/human 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 movie airs live and via streaming on PBS May 15, 2025.