INOVIO’s VOCERYQ Wins FDA Accelerated Approval to Reduce RRP Surgeries

INOVIO announced on October 30, 2026 that the U.S. Food and Drug Administration 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). VOCERYQ, which the company described as the first U.S. FDA-approved DNA medicine, was approved in combination with CELLECTRA 5PSP, INOVIO’s proprietary DNA medicine delivery device, according to INOVIO’s announcement.

The indication was 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 the indication may be contingent on verification and description of clinical benefit in a confirmatory study or studies. The labeled indication states that VOCERYQ is indicated to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis.

RRP-001 Efficacy and Safety Data

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 under the protocol. Of the 32 patients, 26 required three or more surgeries for papilloma excision in the 12 months before treatment and were included in the efficacy evaluation; the median number of surgical excisions in the 12 months prior to the first dose in that population was 4.5, with a range of 3 to 8.

Seven of the 26 patients, or 27 percent (95% CI: 12; 48%), demonstrated a complete response, defined as requiring no surgical excision of papillomas, after 12 months of follow-up, an outcome the company said 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 company reported that VOCERYQ was found to be well tolerated. The most common adverse reactions, with an incidence above 5 percent, were 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, and all 32 patients completed the study.

The product’s safety information directs clinicians to monitor patients for local injection site reactions for at least 30 minutes after treatment. It also warns that procedure-related effects from electroporation, including muscle contractions, transient bleeding and vasovagal reactions, may occur, and states that use should be avoided in patients with ipsilateral implantable cardioverter-defibrillators or pacemakers, metal implants, or skin abnormalities at the treatment site.

VOCERYQ is a plasmid DNA-based immunotherapy designed to generate an immune response using DNA plasmids that encode for HPV-6 and HPV-11 antigens. It is administered using the CELLECTRA delivery device. Following a standard-of-care surgical debulking of visible papilloma prior to the initial administration, no additional surgical intervention is required as part of the 9-week dosing regimen.

Regulatory Path and Launch Plans

The FDA accepted INOVIO’s Biologics License Application for INO-3107 for review on December 29, 2025, with a Standard review classification, and assigned a Prescription Drug User Fee Act review goal date of October 30, 2026, the date by which it intended to take action on the application. The agency indicated it was not planning to hold an advisory committee meeting to discuss the application, according to INOVIO’s December 2025 announcement.

INOVIO filed the BLA under the accelerated approval pathway. In its file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company had not submitted adequate information to justify eligibility for that pathway. INOVIO said at the time that it continued to believe INO-3107 fulfilled the criteria for accelerated approval, planned to request a meeting with the FDA to discuss next steps, and was not planning to seek approval under the traditional pathway.

The application was supported by data from a Phase 1/2 trial and by long-term durability data from a retrospective study of the original participants. According to the December 2025 announcement, 72 percent of patients saw a 50-to-100 percent reduction in the number of surgeries after starting treatment at the end of the first year, a figure that rose to 86 percent at the end of the second 12-month period with no additional dosing, and half of those patients required no surgeries at all.

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.

The FDA previously granted the program Orphan Drug and Breakthrough Therapy designations. The European Commission granted Orphan Drug designation, the United Kingdom awarded an Innovation Passport, and INOVIO has CE-marked its CELLECTRA delivery device in the EU, which allows it to commercialize the device in the EU and other geographies that recognize CE-marking.

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. INOVIO will host a conference call on Monday, November 2, 2026 at 8:00 AM ET to provide additional details on the approval, including key aspects of the label and commercialization.

“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,” said Dr. Jacqueline Shea, INOVIO’s president and chief executive officer.

Dr. Simon Best, associate professor of otolaryngology at Johns Hopkins University and a lead investigator for the 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.”

RRP is a rare disease caused primarily by HPV-6 and/or HPV-11 and is characterized by the development of small, wart-like growths, or papillomas, in the respiratory tract. While the papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications, and the disease can affect the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the current standard of care, though the growths often recur. Based on ongoing analysis of claims data, INOVIO estimates a prevalent population of at least 25,000 RRP patients in the United States, with additional patients diagnosed each year. The company’s December 2025 announcement cited widely referenced U.S. epidemiology data published in 1995 that estimated 14,000 active cases and about 1.8 per 100,000 new cases of RRP in adults each year.