FDA has granted accelerated approval to Inovio's doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd (Voceryq), previously known as INO-3107, a plasmid DNA-based immunotherapy. The company announced on October 30, 2026, that the therapy is approved to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP).¹ The therapy is approved for use with Inovio's Cellectra 5PSP delivery device. According to Inovio, it is the first DNA medicine approved by FDA.¹
Key facts
- Drug: doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd (Voceryq; Inovio)
- Class: plasmid DNA-based immunotherapy (HPV-6/HPV-11 antigens)
- Indication: reduce frequency of surgical papilloma excisions in adults with RRP
- Approval date: October 30, 2026 (FDA accelerated approval)
- Trial: RRP-001 (NCT04398433); phase 1/2
- Primary result: 27% complete response at 12 months (7 of 26)
- Safety: mostly grade 1-2, transient adverse reactions
- Delivery: Cellectra 5PSP device
- Next step: confirmatory study protocol due by end of 2026
"I believe it is in the best interest of RRP patients that the standard of care quickly transition away from surgical interventions to immunotherapy after RRP is diagnosed," said Simon Best, MD, associate professor of otolaryngology at Johns Hopkins University and a lead investigator for the RRP-001 study, in a company press release.¹
What data supported the approval?
The accelerated approval was based on complete response, defined as no requirement for surgical intervention in the 12 months after treatment.¹ The phase 1/2 RRP-001 study (NCT04398433) evaluated the immunotherapy in 32 adults with RRP who had 2 or more surgeries in the year before treatment.¹,² Of these, the 26 patients who had needed 3 or more surgeries in the prior 12 months formed the efficacy population. Their median number of surgical excisions in the year before the first dose was 4.5 (range, 3-8).¹
Of the 26 patients, 7 (27%; 95% confidence interval, 12; 48%) achieved a complete response after 12 months of follow-up.¹ No additional surgical excisions were required during the 9-week dosing window, which follows a standard-of-care surgical debulking.¹ Full clinical and immunologic results from the study were published in Nature Communications in 2025.³
How safe was the therapy?
The most common adverse reactions, occurring in more than 5% of patients, were injection site reactions, headache, fatigue, hypertension, nausea, and dizziness.¹ Most treatment-related adverse reactions were grade 1 or 2 and transient, and no grade 4 or 5 common adverse events were reported.¹ All 32 patients completed the study.¹
How does the DNA medicine work?
RRP is a rare disease caused primarily by human papillomavirus (HPV) types 6 and 11. Wart-like papillomas grow in the respiratory tract and can cause airway obstruction and voice impairment.¹ Surgery to remove papillomas is the standard of care, but the growths often recur.¹ The therapy uses DNA plasmids encoding HPV-6 and HPV-11 antigens to generate an immune response against the virus. The Cellectra device delivers it without chemical adjuvants or lipid nanoparticles.¹
