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OS Therapies said its wholly-owned subsidiary OS Animal Health (OSAH) received USDA feedback on the commercial development pathway for OST-HER2 in canine osteosarcoma and plans to seek conditional licensure based on existing clinical efficacy data while anticipating additional studies to obtain full licensure.
OS Therapies reported a final three-year overall survival rate of 72.7 percent for OST-HER2 (Herlystic™)–treated patients versus 45.8 percent in a combined historical control (p = 0.0006) from its Phase 2b pulmonary metastatic osteosarcoma program. The company says it is preparing regulatory submissions in multiple jurisdictions and plans a Phase 3 CTA to the U.K. MHRA as a precursor to trial initiation.
OS Therapies named Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer to lead commercialization planning for Herlystic (OST-HER2; daznelimgene lisbac). The company described regulatory and financing actions intended to support potential launches in the U.K., U.S., and Europe.