Inovio Pharmaceuticals, Inc. announced on October 30, 2026, that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously referred to as INO-3107. The approval is for the indication to reduce the frequency of surgery in adults with Recurrent Respiratory Papillomatosis (RRP), a rare disease caused by HPV-6 and HPV-11.
The approval is based on data from the RRP-001 study, which evaluated 32 adult patients who had undergone two or more surgeries in the year prior to treatment. In the efficacy population of 26 patients, 27 percent demonstrated a complete response, defined as requiring no surgical excision of papillomas after 12 months of follow-up. The median number of surgical excisions in the 12 months prior to the first dose in the efficacy population was 4.5, with a range of 3 to 8.
VOCERYQ is a plasmid DNA-based immunotherapy that targets the root cause of RRP. It is administered in combination with CELLECTRA 5PSP, the Company’s proprietary DNA medicine delivery device. The treatment involves a standard-of-care surgical debulking of visible papilloma prior to the initial administration, followed by a 9-week dosing regimen where no additional surgical intervention is required.
Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory study. The FDA requires Inovio to submit a draft protocol for the study by the end of 2026, with the expectation of aligning on a final protocol by mid-2027.
Inovio expects to make VOCERYQ available to order and ship in approximately 60 days and anticipates full field deployment during the first quarter of 2027. The Company has engaged Syneos Health to support the recruitment and deployment of its medical and commercial field teams.
Adverse reactions associated with VOCERYQ include injection site reactions, headache, fatigue, hypertension, nausea, and dizziness. The most common reactions were grade 1 and 2 and transient, with no grade 4 or 5 common adverse events reported in the study.
