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# Inovio's First DNA Drug Won Approval on 7 of 26 Patients Avoiding Surgery
- URL: https://bioweek.com/inovios-first-dna-drug-won-approval-on-7-of-26-patients-avoiding-surgery/
- Published: 2026-11-02T06:05:00.000Z
- Updated: 2026-11-02T06:05:00.000Z
- Description: Inovio's Voceryq is the first plasmid DNA immunotherapy to win FDA approval. It cleared on a 27% complete response in a small open-label cohort, and a confirmatory trial is still ahead.
- Author: BioWeek
- Tags: Pipeline, Science

The Food and Drug Administration granted accelerated [approval](https://www.fda.gov/news-events/press-announcements/fda-approves-first-plasmid-dna-based-immunotherapy-adults-recurrent-respiratory-papillomatosis?ref=bioweek.com) on October 30, 2026 to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), formerly INO-3107\. It is the first plasmid DNA-based immunotherapy cleared in the United States, and Inovio's first product after [43](https://www.bizjournals.com/philadelphia/news/2026/10/30/inovio-voceryq-fda-drug-approval-dna-therapy.html?ref=bioweek.com) years. The indication is to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis. The clinical showing that carried it across the line is modest. In an open-label multicenter trial of 32 adults, 7 of the 26 patients who had at least three baseline surgeries (27%) required no surgical intervention during the first year after treatment.

That 27% complete-response rate is the entire accelerated-approval case. The agency based the decision on an intermediate clinical endpoint, surgery reduction, that it judged reasonably likely to predict benefit. Inovio must still run a confirmatory trial to verify and describe clinical benefit. The company says the FDA requires a draft confirmatory-study protocol by the end of 2026, with alignment on a final protocol by mid-2027\. Shares more than [tripled](https://www.marketwatch.com/story/inovio-gets-accelerated-fda-approval-of-voceryq-shares-more-than-triple-after-hours-2640ec82?ref=bioweek.com) after hours on the news. Investors are treating a first-in-class nod as platform proof. The label is treating a one-year surgery holiday in roughly one patient in four as enough to start, with the harder test still unrun.

### A rare disease built around repeat surgery

RRP is a rare disease caused by HPV types 6 and 11\. It produces wart-like growths, or papillomas, in the airways, most often around the larynx and vocal cords. Surgery removes the growths, but the virus persists, so patients face repeated procedures. In some cases RRP carries a risk of becoming cancerous over time. Inovio estimates at least 25,000 prevalent RRP patients in the United States.

The company's [release](https://www.biospace.com/press-releases/inovio-announces-fda-accelerated-approval-of-voceryq-an-immunotherapy-to-reduce-the-frequency-of-surgery-in-adults-with-recurrent-respiratory-papillomatosis-rrp?ref=bioweek.com) fills in the baseline that the 27% figure sits on. In the efficacy population of 26 patients, those who needed 3 or more surgeries in the prior year, the median number of surgeries in the 12 months before dosing was 4.5 (range 3 to 8). Seven of 26 (27%, 95% CI 12-48%) achieved complete response, defined as no surgical excision over 12 months of follow-up. The confidence interval is the part of the filing that should travel with the headline rate. A point estimate of 27% can be as low as 12% or as high as 48% in that sample. Accelerated approval does not require the interval to be tight. A confirmatory trial will.

### Two plasmids, one electroporation pulse

Voceryq is a recombinant plasmid DNA therapy that delivers two plasmids, one encoding HPV-6 and HPV-11 proteins, the other an immune-stimulating molecule called IL-12\. It is given by intramuscular injection using the CELLECTRA 5PSP device, which delivers the dose and applies electroporation, brief electrical pulses that reversibly open pores in cell membranes so the DNA can enter cells. Voceryq received Breakthrough and Orphan Drug designations from the FDA.

The most common adverse reactions, incidence above 5%, were injection site reactions, headache, fatigue, hypertension, nausea, and dizziness. Most treatment-related reactions were grade 1 or 2 and transient. There were no common grade 4 or 5 adverse events. Electroporation-related effects can include brief muscle contractions or tetany, temporary bleeding, and vasovagal reactions including lightheadedness.

### Year two looked better. It is not the approval dataset.

A long-term extension [study](https://pmc.ncbi.nlm.nih.gov/articles/PMC12645365/?ref=bioweek.com) (RRP-002) followed 28 of the 32 patients and was published in The Laryngoscope. Mean surgeries fell from 4.1 before treatment to 1.7 in year one to 0.9 in year two. The complete-response rate, zero surgeries per year, rose from 28% (9 of 32) in year one to 50% (14 of 28) in year two. No serious adverse events or long-term safety concerns were identified. Those year-two numbers are the strongest clinical argument Inovio can make that benefit deepens with time. They are also a different denominator, a different follow-up window, and not the endpoint the FDA used. The approval rests on 7 of 26 patients in year one, not on 14 of 28 in year two.

### Sixty days to ship, a year to lock the next trial

Inovio expects Voceryq to be available to order and ship in roughly 60 days, with a full launch in the first quarter of 2027, and has engaged Syneos Health for its commercial field teams. That timeline puts a first DNA immunotherapy into U.S. clinics before the confirmatory protocol is even aligned. The FDA has asked for a draft of that protocol by the end of 2026 and a final version by mid-2027\. Until that trial reads out, the product's claim is exactly what the accelerated pathway allows: fewer surgeries on an intermediate endpoint, in a small open-label adult cohort, with a complete-response rate whose 95% confidence interval still includes a low double-digit result.

For a company that waited 43 years for a first approval, clearing any bar is a corporate event. For a DNA-medicine platform that now has a U.S. product, the open question is the one the confirmatory trial was designed to answer. Does one patient in four going a year without surgery describe a durable immunotherapy, or a low intermediate bar that still has to be confirmed?