OS Therapies announced the launch of OS Animal Health Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma. OST-HER2 is an off-the-shelf immunotherapy candidate that has shown positive clinical data in both human pediatric and canine osteosarcoma. Parent company OS Therapies is advancing towards an FDA Accelerated Approval submission, anticipated in the third quarter of 2025, for the prevention of recurrence in pediatric patients with fully resected, lung-metastatic osteosarcoma.
Concurrently, its wholly-owned subsidiary, OS Animal Health, is focused on re-establishing USDA conditional approval for OST-HER2 in canine osteosarcoma, with a targeted submission in the second half of 2025. To advance OST-HER2 in the veterinary space with the attention it deserves, OS Animal Health will operate independently from the parent company, with separate funding aligned to the needs of the animal health market. OST-HER2 is also featured in the PBS documentary Shelter Me: The Cancer Pioneers, which 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 movie is available via streaming on the PBS website. OST-HER2, being developed by parent company OS Therapies Inc. for pediatric osteosarcoma, 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 immediately sell. The most recent PRV sale, valued at $155 million, occurred in May 2025.
