Biotechnology company INOVIO (NASDAQ:INO) announced on Monday that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP).

RRP is a debilitating and rare disease caused primarily by HPV-6 and/or HPV-11. RRP is characterised by the development of small, wart-like growths, or papillomas, in the respiratory tract. While these are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications. RRP can also significantly affect quality of life for patients by affecting the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the current standard of care for RRP; however, the papillomas often grow back.

The review classification designated by FDA is Standard, with a Prescription Drug User Fee Act (PDUFA) review goal date of 30 October 2026. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. INOVIO plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. The company is not currently planning to seek approval for INO-3107 under the traditional pathway.

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 was also included, demonstrating that the majority of evaluable patients continued to see clinical benefit in the second 12-month period after treatment, without additional dosing. These data were published in Nature Communications and The Laryngoscope, a journal for otolaryngologists.