Core Insights - OS Therapies has received positive feedback from the UK's MHRA regarding its OST-HER2 application for the prevention or delay of recurrent pulmonary metastatic osteosarcoma [1][2] - The company has initiated the regulatory process in Europe and plans to synchronize its application with the FDA's Accelerated Approval Program through Project Orbis [1][2][4] - OST-HER2 has shown statistically significant benefits in a Phase 2b clinical trial, with a focus on improving 12-month event-free survival rates [5] Regulatory Developments - The company held a successful Scientific Advice Meeting with the MHRA and submitted an Innovative Licensing and Access Pathway (ILAP) application [1][2] - MHRA recommended applying for Project Orbis to align the UK and US regulatory review processes [4] - A European Medicines Agency rapporteur has scheduled a Scientific Advice Meeting for October 2025 [4] Product Information - OST-HER2 is an immunotherapy targeting the HER2 protein, leveraging the immune-stimulatory effects of Listeria bacteria [3] - The product has received Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations from the FDA and EMA [3] - The company anticipates submitting a Biologics Licensing Application (BLA) to the FDA in 2025, which could lead to a Priority Review Voucher [5] Future Developments - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]