Core Viewpoint - OS Therapies has received approval from the World Health Organization for the non-proprietary name 'daznelimgene lisbac' for its cancer immunotherapy product candidate OST-HER2, which is aimed at treating pulmonary metastatic osteosarcoma [1][2][3]. Company Overview - OS Therapies is a clinical stage oncology company specializing in listeria-based cancer immunotherapies, particularly for osteosarcoma and other solid tumors [3]. - The company is recognized as a leader in listeria-based cancer immunotherapies and is developing OST-HER2 to leverage the immune-stimulatory effects of Listeria bacteria [3]. Product Development - OST-HER2 has received multiple designations from regulatory authorities, including Rare Pediatric Disease Designation (RPDD) from the U.S. FDA and Fast-Track and Orphan Drug designations from both the U.S. FDA and European Medicines Agency [3]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [3]. - A Biologics Licensing Application (BLA) for OST-HER2 is anticipated to be submitted to the U.S. FDA in early 2026, with the potential to receive a Priority Review Voucher if approved [3]. Future Plans - OS Therapies is on track to receive regulatory feedback from U.S., UK, and European authorities in December 2025, with plans to file for regulatory approvals starting in January 2026 [3]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [4].