PLYMOUTH MEETING, PA — INOVIO (Nasdaq: INO) has secured U.S. Food and Drug Administration accelerated approval for VOCERYQ, the first plasmid DNA-based immunotherapy authorized in the United States, giving the Plymouth Meeting biotechnology company a commercial product designed to reduce repeated surgeries in adults with recurrent respiratory papillomatosis.
The approval covers VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously known as INO-3107, for reducing the frequency of surgical interventions in adults with the rare, chronic respiratory disease.
The FDA’s decision establishes a regulatory milestone for INOVIO’s DNA medicine platform while introducing a nonsurgical treatment option for patients who often undergo repeated procedures to remove growths from their airways.
The authorization was granted through the FDA’s accelerated approval pathway, which permits certain treatments for serious diseases to enter the market based on clinical measures reasonably likely to predict patient benefit.
Continued approval may depend on results from a confirmatory clinical study. INOVIO must submit a draft study protocol by the end of 2026, with the FDA expecting agreement on a final protocol by mid-2027.
The approval was supported by an open-label, multicenter study involving 32 adults with recurrent respiratory papillomatosis, or RRP, who had undergone at least two surgeries during the preceding year.
Among 26 patients who had required at least three surgeries before treatment, seven, or 27%, needed no additional surgical procedures during the first 12 months after receiving VOCERYQ.
Patients in that efficacy group had undergone a median of 4.5 surgical excisions during the year before treatment, with individual totals ranging from three to eight.
The trial did not include a randomized control group, and the accelerated approval requires additional evidence to verify the treatment’s clinical benefit.
RRP is caused by human papillomavirus types 6 and 11, which can produce recurring wart-like growths in the respiratory tract, particularly around the larynx and vocal cords.
The growths can cause hoarseness, persistent coughing, changes in voice quality and, in severe cases, breathing difficulties.
Surgery can remove the growths but does not eliminate the underlying viral infection, leaving many patients dependent on repeated procedures over several years.
VOCERYQ is designed to stimulate an immune response against cells infected with the HPV types responsible for the disease.
The treatment uses two plasmids, or small DNA molecules, to deliver genetic instructions for HPV-related proteins and an immune response-enhancing molecule known as interleukin-12.
The therapy is administered through intramuscular injection using INOVIO’s CELLECTRA 5PSP device, which applies brief electrical pulses to help the DNA enter cells.
The FDA approved VOCERYQ in combination with the delivery device.
“Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it,” Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research, stated.
Mikhail described the treatment as an approach that uses the immune system to address the underlying cause of the disease rather than relying exclusively on surgical removal of growths.
The most commonly reported adverse reactions included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness.
Most treatment-related reactions in the INOVIO study were mild or moderate and temporary, according to the company. All 32 participants completed the study.
The FDA also identified potential adverse effects associated with the electroporation delivery process, including brief muscle contractions, temporary bleeding, injection-site pain, anxiety and lightheadedness.
VOCERYQ previously received FDA Breakthrough Therapy and Orphan Drug designations, reflecting its development for a serious condition with limited treatment options.
INOVIO expects to begin accepting orders and shipping VOCERYQ within approximately 60 days, with a full commercial launch planned for the first quarter of 2027.
The company has engaged Syneos Health to support recruitment and deployment of its medical and commercial field teams.
The approval represents a significant transition for INOVIO, whose development strategy has focused on DNA-based medicines targeting HPV-related diseases, cancer and infectious diseases.
President and Chief Executive Officer Jacqueline Shea indicated that the company views reducing the need for repeated surgery as the central clinical objective of VOCERYQ.
“VOCERYQ is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP,” Shea stated.
The treatment’s commercial introduction will depend on INOVIO’s ability to establish distribution, physician adoption and patient access while completing the confirmatory research required under the accelerated approval.
The company has not provided pricing or revenue projections for VOCERYQ in its approval announcement.
INOVIO will discuss the FDA decision, prescribing information and commercialization plans during a conference call Monday, November 2, at 8 a.m. Eastern.
The webcast will be available at https://app.webinar.net/6LNlx7kxyqd, with additional information through the company’s investor relations events page at https://ir.inovio.com/events-and-presentations/default.aspx.
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