A first DNA-based immunotherapy gets FDA accelerated approval for airway warts
· BehindLines newsroom · Updated
On 30 October 2026, the US Food and Drug Administration (FDA) granted accelerated approval to Voceryq, an immunotherapy from the company Inovio for adults with recurrent respiratory papillomatosis. According to trade press, it is the first plasmid DNA-based immunotherapy approved in the United States, but not the first medicine approved for the disease: Precigen's Papzimeos, which uses a modified virus, was approved in 2025, according to Reuters. The product, also known by the code INO-3107, aims to reduce the number of surgical procedures patients need. Inovio release carried by Yahoo Finance.
A rare disease that returns after surgery
Recurrent respiratory papillomatosis is a rare, chronic disease. According to the American Journal of Managed Care (AJMC), it is caused by human papillomavirus types 6 and 11 and shows up as small growths, called papillomas, mostly around the larynx and vocal cords. They can cause hoarseness, a persistent cough and, in severe cases, breathing difficulties. Surgery removes the growths but does not cure the disease: the virus can stay in tissue, so patients often need repeated operations. Inovio estimates, from claims data, that at least 25,000 people in the United States live with the condition.
What the treatment does
According to AJMC, Voceryq is an immunotherapy injected into muscle and designed to trigger an immune response against cells infected with virus types 6 and 11. Inovio says it is given with an electroporation device, the Cellectra 5PSP, after a standard operation to remove visible lesions, over a nine-week schedule. The FDA label calls for at least 30 minutes of monitoring after treatment; implant precautions depend on the injection site and, for pacemakers or defibrillators, the side of the intended deltoid injection. FDA
What the trial shows
The approval rests on the RRP-001 study. According to both sources, 32 adults who had undergone at least two operations in the previous year took part. The efficacy analysis covers 26 of them, who had had at least three operations in the preceding twelve months, with a median of 4.5 procedures (range 3 to 8). Twelve months after treatment, 7 of 26 patients, or 27% (95% confidence interval: 12% to 48%), needed no surgery at all: this is the "complete response" used as the endpoint. Inovio says the results were published in Nature Communications and The Laryngoscope.
The most common side effects, according to AJMC, were injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. Most treatment-related reactions were grade 1 or 2 and short-lived, and no common grade 4 or 5 events were reported.
Why "accelerated" matters
An accelerated approval relies on an intermediate endpoint judged reasonably likely to predict clinical benefit. Continued approval may therefore depend on a confirmatory study. According to AJMC, the FDA requires a draft protocol by the end of 2026, with final agreement expected around mid-2027. These sources describe no comparison group in the trial, and the efficacy rests on a small number of patients: the figures should be read as an early result, not as definitive proof.
Reactions and next steps
In Inovio's release carried by Yahoo Finance, Simon Best of Johns Hopkins University, the trial's lead investigator, stresses that "every surgery carries the risk of laryngeal injury" and argues that care should move more quickly from surgery to immunotherapy after diagnosis. AJMC also quotes Karim Mikhail, described as director of the FDA's Center for Biologics Evaluation and Research, who describes an immunotherapy that uses the body's immune system against the underlying cause of the disease. Inovio announces ordering and shipping in about sixty days and a full rollout in the first quarter of 2027. These are company figures and were not independently verified here. This article is general information and does not replace a doctor's advice.