OS Therapies Inc. (NYSE American: OSTX) is set to participate in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference, scheduled for September 9-10 in New York City. According to the announcement, OS Animal Health will also be in attendance, and the company expects to engage with investors and strategic partners during the event. The conference comes at a critical juncture for OS Therapies as it navigates a potentially transformative regulatory period for OST-HER2, its investigational immunotherapy for fully resected pulmonary metastatic osteosarcoma.
The company is anticipating interim three-year overall survival data from its ongoing clinical program, along with key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulatory authorities, all slated for September. These discussions are expected to address potential Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review decisions. Looking further ahead, OS Therapies targets the final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K., and Europe by the fourth quarter of 2026. Additionally, OS Animal Health is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for OST-HER2 in canine osteosarcoma, a move that could broaden the therapy's reach.
The significance of these milestones cannot be overstated. OST-HER2 is designed to leverage the immune-stimulatory properties of listeria bacteria to target the HER2 protein, a well-known oncogene. The therapy aims to initiate a robust immune response against tumor cells by targeting two mutated extracellular epitopes and one mutated intracellular epitope of HER2. Notably, the presence of just one of these epitopes in a tumor or micro-metastasis is sufficient to trigger the desired immune response, potentially making it a versatile option for patients with HER2-expressing tumors.
OS Therapies has already secured multiple regulatory designations that underscore its potential. The FDA has granted Orphan Drug Designation (ODD), Fast Track Designation (FTD), and Rare Pediatric Disease Designation (RPDD) for OST-HER2. In Europe, the European Medicines Agency has also granted ODD, FTD, and Advanced Therapy Medicinal Products (ATMP) classification. These designations are intended to expedite the development and review of therapies that address unmet medical needs, and they highlight the potential of OST-HER2 to make a meaningful impact in osteosarcoma, a rare and aggressive bone cancer primarily affecting children and young adults.
The upcoming conference appearance provides OS Therapies with a platform to communicate its progress and strategic direction to the investment community. As the company approaches these critical regulatory checkpoints, the data and decisions expected in the coming months will be instrumental in shaping the future of OST-HER2 and its potential availability to patients. With a focus on advancing the science and navigating the regulatory landscape, OS Therapies is positioning itself at the forefront of innovative cancer immunotherapy.
For more information about OS Therapies, visit the company's website at www.ostherapies.com.
