OS Therapies Inc. (NYSE American: OSTX) is set to participate in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference on Sept. 9-10 in New York City, where its animal health subsidiary will also be present. The conference provides a platform for the company to engage with investors and strategic partners during a critical juncture in its clinical development.
The company is entering a potentially transformative period for OST-HER2, its investigational immunotherapy for fully resected pulmonary metastatic osteosarcoma. In September, OS Therapies expects interim three-year overall survival data and key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulators. These discussions could lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which may expedite the therapy's path to market.
Looking ahead to the fourth quarter of 2026, the company targets final three-year survival data, a pre-BLA meeting with the FDA, and regulatory submissions in the U.S., U.K., and Europe. These milestones are crucial for advancing OST-HER2, which has already received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA, as well as similar recognitions from the European Medicines Agency.
OST-HER2 leverages a listeria-based platform to stimulate a robust immune response against the HER2 protein, which is overexpressed in many solid tumors. The therapy is designed to target multiple epitopes of HER2, potentially making it effective even if only one epitope is present in a tumor. This approach could offer a new treatment option for osteosarcoma, a cancer that primarily affects children and young adults.
In addition to its human health pipeline, OS Therapies is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for OST-HER2 in canine osteosarcoma. This veterinary application could provide valuable data and open additional revenue streams.
The company's participation in the Moody Capital conference underscores its commitment to advancing its pipeline and engaging with the investment community. As OS Therapies navigates these regulatory and clinical milestones, the outcomes could significantly impact the future of osteosarcoma treatment and the company's trajectory.
