Inovio to submit BLA for INO-3107 in 2H24

INOVIO announced plans to submit a BLA for INO-3107 as a potential treatment for Recurrent Respiratory Papillomatosis in the second half of 2024. This announcement follows an Initial Comprehensive Multidisciplinary Breakthrough Therapy (Type B) Meeting with the FDA on critical aspects of the data package required to submit a BLA under the agency’s accelerated approval program. “Based on productive discussions with the FDA, we believe we now have established a path to submitting a BLA for INO-3107 under the accelerated approval program,” said Dr. Jacqueline Shea, INOVIO’s President & CEO. “Our plan is to complete the submission of our BLA in the second half of 2024 and request a Priority Review. We also plan to initiate a confirmatory trial prior to submission of our BLA. Concurrently, we will continue advancing our commercial plans, with the goal of being ready to launch INO-3107 in 2025.”