INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercialising DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, announced on Friday that the US Food and Drug Administration (FDA) has granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously referred to as INO-3107, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).

This indication has been approved under the accelerated approval programme based on demonstrated complete response defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population. Continued approval for this indication may be contingent on verification and description of clinical benefit in one or more confirmatory studies.

The approval is supported by data from INOVIO's RRP-001 study which evaluated VOCERYQ in 32 adult patients with RRP who had two or more surgeries in the year prior to treatment. During the VOCERYQ dosing window, no additional papilloma surgical excisions were required in the protocol. Of the 32 patients, 26 patients required 3 or more surgeries for papilloma excision in the 12 months prior to treatment and were included in the efficacy evaluation (median number of surgical excisions in the 12 months prior to the first dose in the efficacy population was 4.5). Seven out of the 26 patients (27%) demonstrated a complete response, defined as requiring no surgical excision of papillomas, after 12 months of follow up, which is not expected as part of the natural history of the disease when untreated.

VOCERYQ was found to be well tolerated, with the most common adverse reactions (incidence >5%) including injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Most treatment-related adverse reactions were grade 1 and 2 and transient. There were no grade 4 or 5 common adverse events. All 32 patients completed the study.

The FDA requires INOVIO to submit a draft protocol for a confirmatory study by the end of 2026 with the expectation of aligning on a final protocol by mid-2027.

VOCERYQ was approved in combination with CELLECTRA 5PSP, INOVIO's proprietary DNA medicine delivery device. 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.