Clinical-stage biotechnology company OS Therapies Inc (NYSE-A:OSTX) announced on Thursday that the US Patent & Trademark Office has granted a Notice of Allowance for a patent covering the commercial manufacturing of OST-HER2.

A Patent Term Adjustment of 572 days extends market exclusivity for OST-HER2 in the United States into 2040.

The company is preparing to engage with the US Food & Drug Administration (FDA) following the successful treatment phase of its Phase 2b clinical trial for preventing recurrent, resected lung metastatic osteosarcoma. OS Therapies plans to submit a Biologics Licensing Application in 2025, aiming for conditional or accelerated FDA approval.

OST-HER2 has received rare paediatric disease, fast-track and orphan drug designations for osteosarcoma. The company intends to commercialise OST-HER2 in osteosarcoma, sell a Priority Review Voucher if granted, and expand clinical development into breast cancer and other solid tumours.

Preclinical studies of OST-HER2 in breast cancer have demonstrated significant tumour size reductions and metastasis prevention. The osteosarcoma treatment market was valued at USD1.2bn in 2022, with OST-HER2's lung metastasis prevention opportunity estimated at over USD500m. The breast cancer treatment market reached USD29.2bn in 2023 and is projected to grow to USD53.7bn by 2030.