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Inovio Receives Advanced Therapy Medicinal Product Certificate from European Medicines Agency for Quality and Non-Clinical Data for Lead Candidate INO-3107
Data reviewed complies with standards that would be used to evaluate an EU Marketing Authorization Application PLYMOUTH MEETING, Pa., July 25, 2024
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Data reviewed complies with standards that would be used to evaluate an EU Marketing Authorization Application\nPLYMOUTH MEETING, Pa., July 25, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Medicines Agency's Committee for Advanced Therapies (CAT) has certified the quality and non-clinical data for INO-3107, INOVIO's lead candidate for the treatment of Recurrent Respiratory Papillomatosis (RRP). The certification confirms that INOVIO's chemistry, manufacturing and controls (CMC) data and nonclinical results available to date comply with the scientific and technical standards that would be used for evaluating a European Marketing Authorization Application.\n\n \n \n \n \n \n \n\n \n\"This latest regulatory achievement further validates our efforts to bring INO-3107 to RRP patients around the world and shows that our cross functional development team is meeting the highest of standards in pursuit of that goal,\" said Cheryl Elder, INOVIO's Senior Vice President of Regulatory Affairs. \"We're pleased to receive confirmation that our development efforts in Europe continue to make progress.\"\nThe CAT provides assessment and certification of advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs), providing an important opportunity to identify any potential development issues prior to the submission of a Marketing Authorization Application.\nAbout INO-3107\nINO-3107 is designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells are designed to seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas. In a Phase 1/2 clinical trial conducted with INO-3107, 81.3% (26/32) of patients had a decrease in surgical interventions in the year after INO-3107 administration compared to the prior year, including 28.1% (9/32) that required no surgical intervention during or after the dosing window. Patients in the trial had a median range of 4 surgeries (2-8) in the year prior to dosing. After dosing, there was a median decrease of 3 surgical interventions (95%...