PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that it has completed the rolling submission of its Biologics License Application (BLA) for INO-3107, a DNA-based immunotherapy candidate for adults with recurrent respiratory papillomatosis (RRP), a rare, HPV-related disease of the respiratory tract.
The company submitted the application under the FDA’s Accelerated Approval program and has requested a priority review. INOVIO expects the filing to be accepted by the end of 2025, with a potential Prescription Drug User Fee Act (PDUFA) decision in mid-2026 if priority review is granted. If approved, INO-3107 would become INOVIO’s first commercial product and the first DNA medicine available in the United States.
“The potential to have a meaningful new treatment for RRP brings me so much hope for the RRP community, which has been desperate for relief from the risks and costs of repeated surgery,” said Kim McClellan, President of the RRP Foundation. “Every patient deserves a therapy that works for them and I believe we are now one step closer to surgery being a last resort for the treatment of this disease.”
“This is a pivotal moment in our efforts to deliver on the promise of INO-3107, an innovative DNA immunotherapy candidate that has the potential to become a paradigm-shifting treatment option for RRP,” said Dr. Michael Sumner, Chief Medical Officer of INOVIO. “I’d like to thank the patients and physicians who participated in the INO-3107 clinical trial, as well as our internal team for their tremendous effort in completing INOVIO’s first BLA submission. We look forward to continued communication and collaboration with the FDA during the review process and will be focused on finalizing our preparations for a potential commercial launch in 2026.”
RRP is a rare disease caused primarily by HPV-6 and HPV-11, characterized by wart-like growths in the respiratory tract that can cause airway obstruction and limit speech. Surgery remains the standard of care, but papillomas frequently recur, posing risks of permanent vocal cord damage and other complications.
INO-3107, which previously received Orphan Drug and Breakthrough Therapy designations, is designed to help the immune system target the underlying viral cause of the disease — potentially reducing the need for repeated surgical interventions and improving patients’ quality of life.
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