OS Therapies (NYSE-A:OSTX) has announced that it has received a notice of allowance from the US Patent & Trademark Office (USPTO) covering the manufacturing methods required for OST-HER2.
According to OS, the USPTO has granted a Patent Term Adjustment of 572 days, providing market exclusivity for the OST-HER2 commercial drug product into 2040. The company plans to initiate discussions with the FDA following the successful treatment stage of its Phase 2b clinical trial in the prevention of recurrent, resected, lung metastatic osteosarcoma in anticipation of submitting a biologics licensing application (BLA), and gaining FDA approval in 2025.
The company reports that the FDA has already granted OST-HER2 rare pediatric disease, fast track, and orphan drug designations for osteosarcoma. OS anticipates acquiring a BLA for OST-HER2 in osteosarcoma in late 2025.
