FDA grants Inovio's Voceryq first US approval for a plasmid DNA immunotherapy

The US Food and Drug Administration granted accelerated approval on 30 October 2026 to Inovio Pharmaceuticals' Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis (RRP). The FDA said it is the first approval in the US for an immunotherapy based on plasmid DNA¹.

RRP is a rare, chronic disease in which HPV types 6 and/or 11 cause wart-like growths in the airways, most often around the vocal cords. Surgery removes the papillomas but the virus stays in the tissue, so patients often need repeated operations over many years, and the disease can in some cases turn cancerous¹. Inovio's 2025 filing announcement cited US epidemiology data from 1995 estimating 14,000 active adult cases and about 1.8 new adult cases per 100,000 each year².

What the trial found

The FDA based its decision on an open-label, multicentre trial in 32 adults who had needed two or more surgeries to remove laryngotracheal papillomas in the 12 months before treatment, including one scheduled at entry. Of the 26 patients with at least three surgeries at baseline, 7 (27%) needed no surgery in the first year after treatment¹. Inovio has reported the same Phase 1/2 trial (RRP-001) differently: 72% of patients had a 50-to-100% reduction in surgeries by the end of year one, and in a retrospective follow-up of 28 of the original participants (RRP-002) that share rose to 86% at the end of the second year with no further dosing².

The approval rests on a cut in the frequency of surgery, which the FDA treats as an intermediate endpoint reasonably likely to predict clinical benefit. Inovio must run post-approval trials to confirm that benefit¹.

Voceryq delivers two plasmids into cells: one encodes specific HPV proteins and the other the immune-enhancing molecule IL-12, with the aim of directing the immune system against cells infected with HPV 6 and 11¹. It is given by intramuscular injection with Inovio's CELLECTRA 5PSP device, which uses brief electrical pulses (electroporation) to open temporary pores in cell membranes¹. The most common adverse reactions were injection site reactions, headache, fatigue, hypertension, nausea and dizziness, and the electroporation step can add brief muscle contractions, bleeding at the site and vasovagal reactions¹.

What it means for the market

For Inovio, Voceryq is its first commercial product, and the company had positioned it as the first DNA medicine available in the US². The FDA decision gives developers of DNA-based medicines a US precedent for a plasmid product delivered by a device rather than by lipid nanoparticles or viral vectors, a design choice Inovio has argued avoids the anti-vector immune response seen with viral platforms².

It also shows the FDA accepting a small single-arm dataset for a rare disease under the accelerated pathway, backed by Breakthrough and Orphan Drug designations¹. Inovio had said the FDA advised it that the completed Phase 1/2 trial could support the filing².

Outside the US, the European Commission has granted the product Orphan Drug designation, the CELLECTRA device is CE-marked in the EU, and the UK awarded it an Innovation Passport, the entry point to the Innovative Licensing and Access Pathway². Neither source gives a European filing timetable or a US price.

The evidence base is narrow. The trial was open-label with no control arm and enrolled 32 patients, the longer follow-up figures come from a retrospective study, and continued approval depends on the confirmatory trials the FDA has required¹².