OS Therapies Inc. (NYSE American: OSTX), a clinical-stage oncology company specializing in immunotherapies for osteosarcoma and other solid tumors, has announced its participation in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference, scheduled for September 9-10 in New York City. The company, through its OS Animal Health unit, will engage with investors and strategic partners at the event. This appearance comes at a pivotal time as OS Therapies anticipates significant regulatory and clinical developments for OST-HER2, its investigational therapy for fully resected pulmonary metastatic osteosarcoma.
The company expects to receive interim three-year overall survival data from its ongoing trials in September. Concurrently, it is preparing for key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulatory authorities. These discussions could lead to potential decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which are designed to expedite the development and review of promising therapies. Looking ahead, OS Therapies targets final three-year data, a U.S. Pre-BLA (Biologics License Application) meeting, and regulatory submissions in the U.S., U.K., and Europe in the fourth quarter of 2026.
The significance of these milestones cannot be overstated. Osteosarcoma is the most common type of bone cancer, primarily affecting children and young adults. For patients with fully resected pulmonary metastatic disease, the prognosis remains poor, and there is a high unmet need for effective therapies that can prevent recurrence. OST-HER2 is designed to harness the immune system to target the HER2 protein, which is overexpressed in many osteosarcoma tumors. By leveraging listeria bacteria to stimulate a robust immune response, the therapy aims to attack tumor cells and micro-metastases that express HER2.
OST-HER2 has already received Orphan Drug Designation (ODD), Fast Track Designation (FTD), and Rare Pediatric Disease Designation (RPDD) from the FDA, as well as ODD, FTD, and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. These designations underscore the potential of the therapy and provide incentives to support its development.
In addition to the human oncology program, OS Animal Health is seeking alignment from the U.S. Department of Agriculture (USDA) to reinstate conditional approval for OST-HER2 in canine osteosarcoma. Dogs naturally develop osteosarcoma at a higher incidence than humans, and the therapy could offer a valuable treatment option for veterinary medicine while also providing insights into the human application.
The company's participation in the Moody Capital Conference is expected to facilitate discussions with potential partners and investors who are interested in the progress of OST-HER2. Given the upcoming data readouts and regulatory interactions, the timing of the conference is strategic for OS Therapies to communicate its development plan and the potential impact of its therapy on the oncology landscape.
For more information about OS Therapies, visit www.ostherapies.com. To view the full press release, visit https://ibn.fm/ERaOp.
