FDA approves Voceryq to reduce surgery in recurrent respiratory papillomatosis – Inovio

INOVIO announced that the 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 RRP.
This indication is approved under the accelerated approval program 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 a confirmatory study(ies).

“With the approval of VOCERYQ, we believe our DNA medicine platform has the potential to transform the treatment paradigm for RRP by offering a patient-centric treatment option. VOCERYQ is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP,” said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. “INOVIO is grateful to the patients, study investigators, and the RRP Foundation, who helped make this achievement possible, and also to the FDA, who recognized the significant unmet need in this patient community. We would like to thank our dedicated INOVIO team and their ongoing commitment to patients. We look forward to delivering VOCERYQ to the RRP community and believe it has the potential to become a new standard of care for this devastating disease.”

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 (range: 3 to 8)). Seven out of the 26 patients (27% [95% CI: 12; 48%]) 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. The complete clinical data for VOCERYQ were published in Nature Communications and in The Laryngoscope, the leading journal for the specialists who treat RRP.

“This new FDA-approved therapy brings us an important step closer to ensuring every RRP patient has access to a non-surgical treatment option that works for them. In reaching this milestone, we have shown that patient voices matter in the drug development process,” said Kim McClellan, President of the RRP Foundation. “Patients have often had to endure repeated surgeries to control their RRP disease, but now thanks to the INOVIO team and the patients and investigators involved in the clinical development program for VOCERYQ, a new option is available that has the potential to further transform the treatment landscape for RRP patients. We look forward to continuing to work with clinicians, regulators and our partners in the healthcare industry to further improve the quality of life for those living with RRP.”

Dr. Simon Best, Associate Professor of Otolaryngology at Johns Hopkins University and a lead investigator for INOVIO’s RRP-001 study, said, “The approval of VOCERYQ is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury. I believe it is in the best interest of RRP patients that the standard of care quickly transition away from surgical interventions to immunotherapy after RRP is diagnosed.”

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. See additional Important Safety Information below.

To verify the clinical benefit of VOCERYQ, a confirmatory study is expected to be conducted. 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.

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.

Citation: Amin MR, Belafsky PC , Best, SR et al. DNA Immunotherapy (INO-3107) Results in Long-Term Surgery Reduction in RRP. The Laryngoscope 2025: 1–9, https://doi.org/10.1002/lary.32416.

Morrow MP, Gillespie E, Sylvester A. et al. DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety and immunogenicity of INO-3107. Nat Commun  2025, 16,: 1518 https://doi.org/10.1038/s41467-025-56729-6