Inovio Pharmaceuticals, Inc. announced that the US FDA has accepted for review its Biologics License Application (BLA) for INO-3107, an investigational DNA immunotherapy for the treatment of adults with recurrent respiratory papillomatosis (RRP), a rare HPV-driven disease characterized by recurrent benign growths in the respiratory tract that often require repeated surgical removal.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 30, 2026, and designated the review as Standard. However, Inovio had filed the BLA under the accelerated approval pathway, and in its acceptance letter the FDA noted a potential review issue around whether sufficient information has been provided to justify accelerated approval eligibility. Inovio said it intends to meet with the FDA to discuss next steps to remain eligible under the accelerated approval program but does not plan to pursue a traditional approval route at this time. The agency has indicated that it does not currently plan to hold an advisory committee meeting on the application.
INO-3107’s BLA is supported by data from a Phase 1/2 trial in adults with RRP who had undergone two or more surgeries in the year before treatment. Long-term data included in the submission showed that a majority of evaluable patients continued to experience clinical benefit in the second 12-month period after treatment without additional dosing. RRP is currently managed primarily via surgical debulking, which carries risks of permanent vocal-cord damage, high healthcare costs, and adverse impacts on quality of life.
About INO-3107
INO-3107 consists of plasmid DNA encoding antigens from HPV-6 and HPV-11, as well as an interleukin-12 (IL-12) immune adjuvant. Delivered intramuscularly with electroporation (CELLECTRA™ device), the DNA is taken up by host cells, which then express the encoded viral antigens. This presentation stimulates the immune system, particularly cytotoxic T lymphocytes (CTLs), to recognize and destroy HPV-infected cells.