The US Food and Drug Administration has accepted for review INOVIO Pharmaceuticals’ biologics license application for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis, a rare and debilitating disease caused primarily by HPV-6 and HPV-11 that leads to recurrent benign tumours in the respiratory tract and often requires repeated surgical interventions.
The FDA has granted the application a standard review and set a Prescription Drug User Fee Act target action date of October 30, 2026. The agency has indicated that it is not currently planning to convene an advisory committee meeting for the application.
INOVIO submitted the BLA under the accelerated approval pathway. However, in its filing review, the FDA flagged a potential issue related to whether sufficient information has been provided to support eligibility for accelerated approval. INOVIO has said it intends to engage with the FDA to discuss next steps to address this point while the application continues under review.
The submission is supported by data from a Phase 1/2 clinical trial in adults with RRP who had undergone multiple surgeries in the year prior to enrolment, along with long-term follow-up data demonstrating durability of clinical benefit in many patients without the need for additional dosing. Results from these studies have been published in peer-reviewed journals including Nature Communications and The Laryngoscope.
INO-3107 is a DNA-based immunotherapy designed to generate an antigen-specific T-cell immune response targeting HPV-6 and HPV-11 proteins, with the aim of reducing or preventing papilloma growth. The therapy has received Orphan Drug and Breakthrough Therapy designations from the FDA, Orphan Drug designation from the European Commission, and an Innovation Passport designation in the UK. INOVIO has also obtained CE marking in the European Union for its proprietary CELLECTRA delivery device, supporting potential future commercialisation in Europe and other CE-recognising markets.
Recurrent respiratory papillomatosis currently has no approved medical therapies and is managed largely through repeated surgeries, which can be associated with significant morbidity, including voice damage. If approved, INO-3107 could become the first non-surgical treatment option for adults with the disease, offering the potential to reduce surgical burden and improve quality of life.
