INOVIO Completes Rolling BLA Submission Seeking Accelerated Approval for INO-3107 as a Treatment for RRP in Adults

Core Insights - INOVIO has completed the rolling submission of its Biologics License Application (BLA) for its DNA immunotherapy candidate INO-3107, aimed at treating recurrent respiratory papillomatosis (RRP) in adults [1][2] - The BLA was submitted under the FDA's Accelerated Approval program, with a request for priority review, which could lead to a decision within six months [2][4] - If approved, INO-3107 would be INOVIO's first commercial product and the first DNA medicine available in the United States [2] Company Overview - INOVIO is a biotechnology company focused on developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases [8] - The company utilizes a proprietary DNA medicines platform that includes precisely designed DNA plasmids delivered by its investigational medical device, CELLECTRA [7] Product Details - INO-3107 is designed to elicit an antigen-specific T cell response against HPV-6 and HPV-11 proteins, potentially preventing or slowing the growth of new papillomas [3][4] - In a Phase 1/2 trial, 72% of participants experienced a 50-to-100% reduction in the number of surgeries required after one year of treatment, with this number increasing to 86% after two years [3][4] Market Context - RRP is a rare disease primarily caused by HPV-6 and HPV-11, characterized by wart-like growths in the respiratory tract, which can lead to severe complications [3][4] - The standard treatment involves surgery to remove papillomas, but they often regrow, highlighting the need for effective alternative therapies [3][4] Regulatory Status - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, facilitating its expedited review process [4][6] - The company anticipates receiving file acceptance by the end of 2025, with a potential Prescription Drug User Fee Act (PDUFA) date in mid-2026 if priority review is granted [4][6]