The FDA has granted accelerated approval to VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously referred to as INO-3107, to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis. VOCERYQ is a plasmid DNA-based immunotherapy, and INOVIO said it is the first FDA-approved DNA medicine.
The approval is based on the company's RRP-001 study of 32 adults with RRP who had at least two surgeries in the year before treatment. The efficacy population included 26 patients who had three or more papilloma excisions in the previous 12 months; their median number of pre-treatment excursions was 4.5 (range: 3 to 8). Seven of the 26 patients (27% [95% CI: 12-48%]) achieved a complete response, defined as requiring no surgical excision of papillomas after 12 months of follow-up.
Continued approval may depend on verification of clinical benefit in a confirmatory trial. INOVIO must submit a draft protocol for that study by the end of 2026, with a final protocol expected by mid-2027.
The most common adverse reactions, each with an incidence above 5%, were injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Most treatment-related reactions were grade 1 or 2 and transient. There were no grade 4 or 5 events.
VOCERYQ targets HPV-6 and HPV-11, the primary causes of RRP. It is administered with INOVIO's CELLECTRA 5PSP delivery device following a surgical debulking before the first dose. INOVIO expects the drug to be available to order and ship in about 60 days, with full commercial launch in the first quarter of 2027.
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