Core Viewpoint - INOVIO's Biologics License Application (BLA) for INO-3107 has been accepted by the FDA for review as a potential treatment for adults with recurrent respiratory papillomatosis (RRP), with a standard review classification assigned [1][2] Group 1: FDA Review Process - The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, for INO-3107, indicating when it intends to take action on the application [2] - INOVIO filed the BLA under the accelerated approval pathway, although the FDA has raised concerns about the adequacy of information submitted for this pathway [3] Group 2: Clinical Data and Efficacy - INO-3107 has shown potential therapeutic benefits in clinical trials, with 72% of patients experiencing a 50-to-100% reduction in surgeries after one year of treatment, increasing to 86% in the second year without additional dosing [6][4] - The BLA is supported by data from a Phase 1/2 trial involving adult patients with RRP who had undergone multiple surgeries prior to treatment, demonstrating long-term clinical benefits [4][6] Group 3: Disease Background and Market Need - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to the development of benign papillomas in the respiratory tract, which can cause severe complications [5] - Current standard care involves surgical removal of papillomas, but they often regrow, highlighting the need for effective non-surgical treatment options [5] Group 4: INO-3107 and its Mechanism - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially preventing or slowing the growth of new papillomas [6][7] - The treatment has shown a strong immune response and was well tolerated in clinical trials, with mostly low-grade adverse effects reported [6][7] Group 5: Regulatory Designations and Market Access - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, as well as Orphan Drug designation from the European Commission [8] - The CELLECTRA delivery device has been CE-marked in the EU, allowing for commercialization in regions recognizing this certification [8]

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]