INOVIO to Begin Rolling Submission of BLA for INO-3107 for the Treatment of RRP in Adults

Core Viewpoint - INOVIO is on track to complete the Biologics License Application (BLA) for INO-3107 by the end of 2025, with the FDA agreeing to its rolling submission timeline for the treatment of Recurrent Respiratory Papillomatosis (RRP) [1][2] Group 1: Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [7] - The company utilizes a proprietary DNA medicines platform that includes DNA plasmids and the CELLECTRA delivery device, which optimally delivers DNA medicines without the need for chemical adjuvants [6] Group 2: Product Information - INO-3107 is an investigational DNA medicine targeting HPV-6 and HPV-11, designed to elicit a T cell response to combat these infections [4] - In a Phase 1/2 trial, 72% of patients experienced a 50-to-100% reduction in surgeries after one year of treatment with INO-3107, increasing to 86% after two years [4] Group 3: Regulatory Designations - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, allowing for accelerated approval based on Phase 1/2 trial data [5] - The European Commission has also granted Orphan Drug designation to INO-3107, and the UK has awarded it the Innovation Passport [5] Group 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] - The estimated prevalence of RRP in the U.S. is about 14,000 active cases, with approximately 1.8 new cases per 100,000 adults each year [3]