OS Therapies targets January BLA filing for OST-HER2 following successful Type C meeting with FDA скачать в хорошем качестве

OS Therapies targets January BLA filing for OST-HER2 following successful Type C meeting with FDA

OS Therapies Inc (NYSE-A:OSTX) chief business officer Gerald Commissiong talked with Proactive's Stephen Gunnion about the company’s recent regulatory progress for its OST-HER2 immunotherapy platform targeting osteosarcoma. Commissiong detailed how OS Therapies acquired rights to a listeria-based therapy originally developed by Advaxis and how this technology has evolved into a precision platform targeting HER2-expressing cancers. The OST-HER2 approach uses attenuated listeria engineered to infect cancer cells, triggering a robust immune response. “Basically, once infected with the listeria, our vector releases additional cancer antigens,” Commissiong explained, noting how this mechanism amplifies immune activity via T cells, NK cells, and dendritic cells. He outlined progress with regulators, including a Type C meeting with the FDA, pre-marketing discussions with the MHRA in the UK, and a meeting with the European CHMP. “The tenor of those conversations… is around trying to find a pathway to get this drug into patients' hands sooner,” he said, adding that discussions included using historical control data and biomarkers as surrogate endpoints for accelerated approval. Commissiong also revealed the broader pipeline, including constructs targeting HPV-driven cancers and prostate cancer. Key next steps include biomarker analysis and initiation of a confirmatory study. Visit Proactive’s YouTube channel for more biotech and pharma interviews. Don’t forget to like this video, subscribe to the channel, and enable notifications for future content. #OSTHER2 #OSTherapies #Osteosarcoma #CancerImmunotherapy #FDAapproval #Biotech #ListeriaTherapy #CancerResearch #AcceleratedApproval #OncologyInnovation #HPVcancer #ProstateCancer #MHRA #CHMP