FDA Approves Voceryq, the First Plasmid DNA Immunotherapy, for Recurrent Respiratory Papillomatosis
On October 30, 2026, the FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) from Inovio Pharmaceuticals. It is approved to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) types 6 and 11.
The FDA calls Voceryq the first plasmid DNA-based immunotherapy it has ever approved. Instead of using a virus to carry genes into the body, it uses plain, circular pieces of DNA called plasmids. It is also the second RRP treatment to reach the market in just over a year, after Precigen's Papzimeos in August 2025.
What RRP does to patients
In RRP, HPV-6 or HPV-11 infects cells lining the airway, most often in the voice box (larynx). The infected cells grow into benign, wart-like tumors called papillomas. They are not cancer, but they keep coming back. As they grow, they can make the voice hoarse and narrow the airway.
For decades, the main treatment has been surgery to cut the papillomas out, again and again. In Voceryq's pivotal trial, patients in the main efficacy group had needed a median of 4.5 surgeries (range 3 to 8) in the year before treatment. Each procedure means anesthesia, recovery time, and a risk of scarring in the airway.
How Voceryq works
Voceryq contains two plasmids:
One carries genes for HPV-6 and HPV-11 proteins, the targets the immune system needs to learn to recognize infected cells.
The other carries the gene for interleukin-12 (IL-12), a signaling protein that strengthens T-cell responses.
The plasmids are injected into muscle. A handheld device called CELLECTRA 5PSP then delivers brief electrical pulses to the injection site. This step, called electroporation, briefly opens tiny pores in the muscle cell membranes so the DNA can get inside. The muscle cells then make the HPV proteins and IL-12, which prime the patient's T cells to find and destroy HPV-infected cells in the airway.
Treatment starts with surgery to remove the existing papillomas. Patients then receive four doses, one every three weeks, over nine weeks, with no additional surgery during the dosing period.
Is it a gene therapy?
The FDA's announcement calls Voceryq an immunotherapy, not a gene therapy. But it works by delivering genes into the patient's own cells, which then make the active proteins. It was reviewed by the FDA's Center for Biologics Evaluation and Research (CBER) and appears on the agency's list of Approved Cellular and Gene Therapy Products, next to viral-vector therapies such as Luxturna and Zolgensma.
The difference is the delivery vehicle. Viral vectors are very efficient at getting genes into cells, but the body can mount an immune response against the virus shell itself. Plasmids have no shell, which makes repeat dosing more practical (Voceryq is given four times), and they are simpler to manufacture. The trade-off is that bare DNA enters cells far less readily, which is why electroporation is needed. If you are new to how genes are delivered into cells, The Life-Changing Power of Gene Therapy explains vectors and other delivery methods from the ground up.
What the trial showed
The approval is based on the RRP-001 study, which enrolled 32 adults who had needed two or more surgeries in the previous year. The main efficacy analysis included the 26 patients who had needed at least three surgeries in the previous 12 months.
7 of 26 patients (27%; 95% CI 12% to 48%) needed no surgery at all during the first 12 months after treatment, which the trial counted as a complete response.
The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea, and dizziness.
Voceryq had also received Breakthrough Therapy and Orphan Drug designations.
Accelerated approval, and what comes next
Accelerated approval means the FDA based its decision on an intermediate endpoint, here a reduction in how often patients need surgery, and requires further study to confirm the clinical benefit. According to Inovio, the FDA expects a draft protocol for the confirmatory study by the end of 2026, with a final protocol agreed by mid-2027.
Inovio says Voceryq should be available to order in about 60 days, with its full field team in place during the first quarter of 2027. The company has not announced a price.
Two very different tools for one rare disease
Adults with RRP now have two FDA-approved options, and they could hardly be more different in design. Papzimeos (zopapogene imadenovec-drba) uses an adenovirus vector to deliver its HPV genes and received full approval in August 2025. Voceryq uses bare plasmid DNA and electroporation, and has accelerated approval.
It is tempting to compare their response rates, but the trials enrolled different patients and were not designed to be compared head to head. The more useful questions for the next few years are how long responses last, which patients benefit most from each approach, and whether either treatment can eventually spare people from the cycle of repeat surgery altogether.
The bottom line
Voceryq gives muscle cells the genetic instructions to make HPV proteins and IL-12, turning the body into its own vaccine factory against the virus behind RRP. In its pivotal trial, about one in four heavily treated patients needed no surgery for a year. It is the first plasmid DNA immunotherapy the FDA has approved, and a real-world test of whether non-viral gene delivery can hold its own next to viral vectors.
Keep exploring with Gene Tech Times
Free guide: subscribe to the Gene Tech Times Briefing on our homepage and get Every FDA-Approved Gene Therapy at a Glance in your inbox.
Watch: 30-second gene therapy Shorts on Gene Tech Times Academy.
Read: The Cheat Codes of Our Genes, real stories of mutations that make some people immune to disease.
New to gene therapy? Start with The Life-Changing Power of Gene Therapy.
As an Amazon Associate, Gene Tech Times earns from qualifying purchases.
— T.N., Gene Tech Times
Comments