On October 30, 2026, local time, INOVIO announced that the U.S. FDA has
granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and
lalikinogene sifuplasmid-gxfd, previously known as INO-3107) to reduce the
frequency of surgery in adults with recurrent respiratory papillomatosis
(RRP).
This indication was approved under the accelerated approval pathway based on complete response data showing no need for surgical intervention within 12 months after treatment in the efficacy population; continued approval may depend on the verification and description of clinical benefit in confirmatory studies.
Significance of Approval and Launch Plans
Voceryq is a plasmid DNA immunotherapy targeting HPV-6 and HPV-11, the underlying cause of RRP, and provides a non-surgical treatment option for adults with RRP. INOVIO stated that this is the first DNA drug approved by the U.S. FDA and also validates its DNA drug platform technology. Dr. Jacqueline Shea, President and Chief Executive Officer of INOVIO, said that Voceryq is designed to reduce the surgical burden caused by RRP. The company thanked patients, investigators, the RRP Foundation, and the FDA, and hopes that Voceryq will become a new standard treatment option for the disease.
Clinical Data
The approval was supported by the RRP-001 study. The study evaluated Voceryq in 32 adult patients with RRP who had undergone at least 2 surgeries within the year before treatment. The efficacy assessment included 26 patients who required 3 or more papilloma excision surgeries within the 12 months before treatment; in this population, the median number of surgical excisions in the 12 months before treatment was 4.5 (range 3 to 8). After 12 months of follow-up, 7 of the 26 patients (27%; 95% CI: 12% to 48%) achieved a complete response, meaning they did not require surgical excision of papillomas. The press release stated that this result would not normally be expected in the untreated natural history of the disease. The full clinical data for Voceryq have been published in Nature Communications and The Laryngoscope.
Confirmatory Study and Indication
To verify the clinical benefit of Voceryq, a confirmatory study is expected to be conducted. The FDA requires INOVIO to submit a draft study protocol by the end of 2026 and expects agreement on the final protocol by mid-2027. The indication is to reduce the frequency of surgical papilloma excision in adults with RRP; this indication is based on accelerated approval, and continued approval may depend on verification of clinical benefit in confirmatory studies.
Safety Information
Voceryq was generally well tolerated. The most common adverse reactions (incidence >5%) included injection site reactions, headache, fatigue, hypertension, nausea, and dizziness. Most treatment-related adverse reactions were grade 1 and grade 2 and transient; no common grade 4 or grade 5 adverse events were observed. All 32 patients completed the study.
Important safety information includes the following: injection site reactions may occur, and patients should be monitored for at least 30 minutes after treatment and managed accordingly.
