FDA Approves Inovio's Voceryq DNA Immunotherapy for RRP

The US Food and Drug Administration (FDA) granted accelerated approval on 30 October 2026 to INOVIO's VOCERYQ, a plasmid DNA immunotherapy given with an electroporation device, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP). In the main study, 7 of 26 evaluated adults needed no surgery for 12 months after treatment.

RRP is a rare disease in which HPV types 6 and 11 cause wart-like growths in the airway, often in the voice box. Surgery to remove the growths is the standard treatment, but the papillomas tend to return, so many patients face repeated operations. The FDA calls VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, formerly INO-3107) the first plasmid DNA-based immunotherapy for adults with RRP; INOVIO calls it the first FDA-approved DNA medicine. It is not authorised in Ireland or the EU.

What did the FDA approve?

VOCERYQ is approved to reduce the frequency of surgical papilloma excisions in adults with RRP. According to the FDA, the product delivers two plasmids: one encodes proteins from HPV types 6 and 11, and the other encodes interleukin-12 (IL-12), an immune-signalling molecule. It is injected into muscle and then delivered into cells using the CELLECTRA 5PSP device, which applies brief electrical pulses (electroporation).

The approval was granted to Inovio Pharmaceuticals, Inc. The FDA said VOCERYQ had Breakthrough Therapy and Orphan Drug designations. Karim Mikhail, Director of the FDA's Center for Biologics Evaluation and Research, said adults with RRP "often face an exhausting and relentless cycle of repeated surgeries", and that the approval could mean "fewer surgeries, fewer disruptions, and more time living their lives on their own terms."

What did the RRP-001 trial show?

The approval rests on INOVIO's RRP-001 study (ClinicalTrials.gov NCT04398433), an open-label, single-group Phase 1/2 trial at sites in the United States. It enrolled 32 adults who had needed two or more surgeries in the previous 12 months, including a scheduled surgery at trial entry.

The efficacy group included the 26 patients who had needed three or more surgeries in the 12 months before treatment. INOVIO reports a median of 4.5 surgeries in that year (range 3 to 8). Seven of the 26 (27%, 95% confidence interval 12% to 48%) had a complete response, defined as needing no surgical removal of papillomas in the 12 months after treatment.

The FDA said the approval was based on reduced surgical frequency, an intermediate endpoint "reasonably likely to predict clinical benefit".

How is VOCERYQ given?

INOVIO says patients first have standard surgery to remove visible papilloma, and no further surgery is required during its 9-week dosing regimen. In RRP-001, as listed on ClinicalTrials.gov, participants received intramuscular doses followed by electroporation at Day 0, Week 3, Week 6 and Week 9. The trial registry lists an earlier device, CELLECTRA 2000, for the study, while the approval covers use with CELLECTRA 5PSP. Full dosing instructions are in the US prescribing information.

What are the safety findings?

The FDA and INOVIO list the most common adverse reactions (incidence above 5%) as injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. INOVIO says most treatment-related reactions were grade 1 or 2 and short-lived, with no common grade 4 or 5 adverse events.

The label carries a warning on injection site reactions, with monitoring for at least 30 minutes after treatment. The FDA lists possible electroporation effects including brief muscle contractions or tetany, temporary bleeding at the site, anxiety, fainting-type (vasovagal) reactions, transient changes in creatine phosphokinase, and redness and pain at the injection site. INOVIO says use should be avoided in patients with implanted defibrillators or pacemakers on the same side, metal implants, or skin abnormalities at the treatment site.

What does accelerated approval mean here?

Accelerated approval allows the FDA to approve treatments for serious conditions on a surrogate or intermediate endpoint. Continued approval may depend on a confirmatory study. INOVIO says the FDA requires it to submit a draft protocol by the end of 2026, aiming to agree a final protocol by mid-2027.

VOCERYQ is the second RRP immunotherapy approved by the FDA. On 14 August 2025 the agency approved Precigen's PAPZIMEOS (zopapogene imadenovec-drba), a non-replicating adenoviral vector immunotherapy given as four subcutaneous injections over 12 weeks, for adults with RRP who needed three or more surgeries a year. In its pivotal study, the FDA reported that 18 of 35 patients (51.4%) needed no surgery in the 12 months after treatment. The two products were studied in separate single-arm trials and have not been compared head to head.

Is VOCERYQ available in Ireland or the EU?

No. The European Medicines Agency (EMA) medicines database lists no authorisation for VOCERYQ, and INOVIO's 30 October announcement does not mention an EU marketing application. The European Commission granted an orphan designation for doruxapapogene ralaplasmid in RRP on 22 May 2023 (EU/3/23/2785). The EMA notes that orphan designation does not mean a medicine is available or authorised.

PAPZIMEOS also holds an EU orphan designation for RRP (EU/3/23/2887, 12 January 2024) and is likewise not listed as authorised in the EMA database. We found no official Irish source (HSE, hospital or Irish ENT society) describing RRP services, so we do not report on care pathways in Ireland.

Frequently asked questions

What is recurrent respiratory papillomatosis?

RRP is a rare disease caused mainly by HPV types 6 and 11, in which benign wart-like growths form in the airway. INOVIO notes they can block the airway and affect the voice, and that they often regrow after surgery.

Is VOCERYQ a cure for RRP?

No such claim is made. The approved use is to reduce the frequency of surgery, and in the main study 27% of the efficacy group needed no surgery for 12 months after treatment.

When will VOCERYQ be available in the US?

INOVIO expects it to be available to order and ship in about 60 days from 30 October 2026, with full field deployment in the first quarter of 2027. The price has not been disclosed.

Can patients in Ireland get VOCERYQ?

It is not authorised in Ireland or the EU. Anyone with RRP should talk to their ENT specialist about treatment options; this article is not medical advice.

Outlook

The next milestones are INOVIO's draft confirmatory study protocol, due to the FDA by the end of 2026, and the US launch timeline it has set out for early 2027. For Europe, the open question is whether INOVIO will file with the EMA; it has announced no such plan. Priya Life Science will report any EU application or Irish availability when official sources confirm it.

Sources

• US Food and Drug Administration, FDA Approves First Plasmid DNA-Based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis, 30 October 2026
• INOVIO Pharmaceuticals (SEC Form 8-K, Exhibit 99.1), INOVIO Announces FDA Accelerated Approval of VOCERYQ, 30 October 2026
• ClinicalTrials.gov, INO-3107 With Electroporation in Participants With HPV-6- and/or HPV-11-Associated RRP (NCT04398433), accessed 3 November 2026
• US Food and Drug Administration, FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis, 14 August 2025
• European Medicines Agency, EU/3/23/2785: orphan designation for treatment of recurrent respiratory papillomatosis, accessed 3 November 2026
• European Medicines Agency, EU/3/23/2887: orphan designation for treatment of recurrent respiratory papillomatosis, accessed 3 November 2026
• INOVIO Pharmaceuticals, INOVIO Announces Orphan Drug Designation for INO-3107 from the European Commission, 23 May 2023

Cover image: AI-generated illustration.