INOVIO, a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard.

The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application.

INOVIO filed its BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company has not submitted adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval. INOVIO plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. INOVIO is not currently planning to seek approval for INO-3107 under the traditional pathway.

"We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease and that every RRP patient deserves access to a non-surgical treatment option that can work for them," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "In clinical trials INO-3107 demonstrated it has the potential to expand the treatment options for RRP patients. This is based on a unique mechanism of action, clinical effectiveness and tolerability data and the simplicity of its patient centric treatment regimen, which does not require additional surgeries during the dosing window. Every surgery matters to patients and we look forward to continuing to collaborate with the FDA during the BLA review cycle."

The BLA is supported by data from a Phase 1/2 trial evaluating INO-3107 in adult patients with RRP who had two or more surgeries in the year prior to treatment. Long-term durability data from a retrospective trial of the original trial participants was also included in the BLA filing, demonstrating that the majority of evaluable patients continued to see clinical benefit in the second twelve-month period after treatment, without additional dosing. These data were published in Nature Communications and The Laryngoscope, the leading journal for otolaryngologists.