PLYMOUTH MEETING, PA — Biotechnology firm INOVIO (NASDAQ: INO) recently announced plans to submit a Biologics License Application (BLA) for its innovative DNA medicine, INO-3107, potentially paving the way for a breakthrough treatment for Recurrent Respiratory Papillomatosis (RRP). The company aims to submit the BLA under the U.S. Food and Drug Administration’s (FDA) accelerated approval program in the latter half of 2024.
This announcement follows a comprehensive Type B meeting with the FDA, during which key aspects of the required data package for the BLA were discussed. INOVIO’s CEO, Dr. Jacqueline Shea, expressed optimism about the path forward, stating, “Based on productive discussions with the FDA, we have established a path to submitting a BLA for INO-3107 under the accelerated approval program.”
INO-3107, if approved, would be the first DNA medicine accessible to RRP patients in the United States and also mark INOVIO’s first approved product. The FDA has previously granted Orphan Drug and Breakthrough Therapy designations to INO-3107, indicating that the agency recognizes the drug’s potential to address unmet medical needs.
In anticipation of a positive outcome, INOVIO plans to initiate a confirmatory trial prior to the BLA submission. The company also intends to request a Priority Review, which could expedite the FDA’s review process to approximately six months, compared to the standard timeline of around ten months.
Dr. Shea further outlined INOVIO’s strategic plans, stating, “Our goal is to be ready to launch INO-3107 in 2025.” In preparation for this potential market entry, INOVIO continues to advance its commercial plans.
INO-3107’s potential impact extends beyond the U.S., having also received Orphan Drug designation from the European Commission. Additionally, INOVIO’s delivery device, CELLECTRA®, has met the European Union’s safety, health, and environmental standards, as evidenced by its CE marking.
This announcement marks a significant milestone for INOVIO and could herald a new era in the treatment of RRP. Investors will likely watch closely as the company navigates the regulatory path towards potential approval and commercialization of this pioneering DNA medicine.
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