Could a new DNA-based immunotherapy reduce the need for repeated surgeries among patients with a rare respiratory condition? In a significant development, the US Food and Drug Administration (FDA) has granted accelerated approval to Inovio Pharmaceuticals’ immunotherapy, Voceryq, for adults with recurrent respiratory papillomatosis (RRP). The treatment aims to reduce the frequency of surgeries in patients with this chronic condition, which causes non-cancerous tumours to develop in the respiratory tract.
How Does Voceryq Work?
RRP is caused by human papillomavirus (HPV) types 6 and 11. The infection leads to the growth of small tumours called papillomas, which can affect speech and obstruct the airway. Although these growths are benign, patients often require repeated surgeries to remove them. Unlike conventional surgical procedures, Voceryq targets the underlying viral infection by stimulating the body’s immune response against HPV-6 and HPV-11. The DNA-based immunotherapy contains two plasmids designed to trigger an immune response. Patients receive four doses at three-week intervals.
Clinical Trial Shows Reduction in Surgical Procedures
The FDA’s accelerated approval was based on data from an open-label Phase 1/2 clinical trial involving 32 adults with RRP. Among 26 patients who had undergone at least three surgeries in the previous year, seven experienced a complete response, meaning they required no further surgery during the 12-month follow-up period. Overall, the study demonstrated a statistically significant reduction in surgical interventions after treatment. However, Voceryq does not eliminate the need for surgery entirely. Patients must undergo an initial procedure to remove existing papillomas before starting immunotherapy. The FDA has also required Inovio to conduct a confirmatory study to verify the treatment’s clinical benefits.
Inovio’s Drug to Compete with Existing RRP Treatment
Voceryq enters a market where Precigen’s Papzimeos became the first FDA-approved treatment for RRP in 2025. Both immunotherapies target HPV-6 and HPV-11, although they use different approaches. Inovio CEO Jacqueline Shea highlighted a potential advantage of Voceryq: its treatment schedule does not require additional surgeries before the third and fourth doses. The company estimates that approximately 25,000 adults in the US live with RRP and believes many patients are still seeking alternatives to repeated surgical procedures.
Pricing and Market Launch
Inovio has set the price of Voceryq at $115,000 per dose, bringing the cost of the complete four-dose treatment course to $460,000, matching the list price of Precigen’s competing therapy. The company expects to make the treatment available within 60 days and is also exploring regulatory approvals in Europe, the United Kingdom and other markets. The approval marks an important development in the treatment of recurrent respiratory papillomatosis, offering patients another immunotherapy option while highlighting the growing role of DNA-based treatments in rare diseases. As reported by MedCity News, Inovio expects Voceryq to expand treatment options for adults with RRP and provide an alternative approach to managing a condition that often requires repeated surgeries.