INOVIO is leveraging a cutting-edge platform to advance DNA medicine candidates with the potential to transform disease prevention and treatment paradigms and improve patients’ lives.
INO-3107: Potential Breakthrough Treatment for RRP in Adults
OVERVIEW
INO-3107 is a DNA immunotherapy that is designed to teach the body to mount an effective immune response to HPV-6 and HPV-11, the strains of HPV that cause Recurrent Respiratory Papillomatosis (RRP).
In a Phase 1/2 trial, 72% of patients saw a 50 to 100% reduction in the number of surgeries in the first year after starting treatment with INO-3107. INO-3107 was well tolerated, with most patients experiencing mostly low-grade (Grade 1) treatment-emergent AEs such as injection site pain and fatigue.
In a retrospective study involving 28 of the original trial participants (RRP-002), the number of patients experiencing a 50 to 100% reduction in surgeries increased to 86% in the second year, with no additional dosing. Half of those patients required no surgeries at all.
Published immunological data showed that INO-3107 induced new populations of antigen specific cytotoxic T cells in the blood that traveled to airway tissue and were associated with clinical benefit as measured by reduced need for surgeries.
TRIAL DETAILS AND REGULATORY DESIGNATION
The FDA has advised that INOVIO can submit a biologics license application (BLA) under the accelerated approval pathway using data from our completed Phase 1/2 trial. INOVIO aims to complete the submission of the BLA for INO-3107 in 2H25 and receive file acceptance with priority review from FDA by year end, allowing for a PDUFA date in mid-2026
