RRP Accelerated Approval: What VOCERYQ Means for Manufacturing Teams

On October 30, 2026, the FDA granted accelerated approval to VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), a plasmid DNA-based immunotherapy from INOVIO, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).¹ Previously known as INO-3107, the product is the first DNA medicine approved by the FDA.

RRP is a rare disease caused primarily by human papillomavirus (HPV) types 6 and 11, which drive recurring benign growths in the respiratory tract that can obstruct the airway.¹ Surgery is the current standard of care, but papillomas frequently return.

What Data Supported the Approval?

The decision rests on the RRP-001 study, which enrolled 32 adults who had undergone 2 or more surgeries in the year before treatment.¹ In the efficacy population of 26 patients, each of whom had required 3 or more surgeries in the prior 12 months, 7 (27%) achieved a complete response, defined as no surgical excision of papillomas through 12 months of follow-up. The most common adverse reactions included injection site reactions, headache, and fatigue, and most treatment-related events were grade 1 or 2. Continued approval may be contingent on a confirmatory study; the FDA requires INOVIO to submit a draft protocol by the end of 2026.

“With the approval of VOCERYQ, we believe our DNA medicine platform has the potential to transform the treatment paradigm for RRP by offering a patient-centric treatment option. VOCERYQ is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP,” said Jacqueline Shea, PhD, CEO, INOVIO, in a press release.¹

VOCERYQ is the second approved therapy for RRP.² In August 2025, the FDA granted full approval to Precigen’s Papzimeos (zopapogene imadenovec-drba), an adenoviral vector-based immunotherapy that also targets HPV-6 and HPV-11.

Why Does This Approval Matter?

As the first FDA-approved DNA medicine, VOCERYQ sets a regulatory precedent for a nonviral modality built on plasmids produced through bacterial fermentation rather than viral vector or lipid nanoparticle manufacturing.¹ It is also approved in combination with INOVIO’s CELLECTRA 5PSP electroporation device, placing drug-device combination controls and device reliability at the center of commercial readiness. INOVIO demonstrated an earlier-generation CELLECTRA manufacturing process could be transferred to contract manufacturers.

The approval also follows the FDA’s October launch of its Rare Disease Framework Initiative, which signals risk-based chemistry, manufacturing, and controls review for rare disease products.³

“The approval of VOCERYQ is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury. 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, Johns Hopkins University, in a press release.¹

References

1. INOVIO Pharmaceuticals, Inc. INOVIO announces FDA accelerated approval of VOCERYQ, an immunotherapy to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP). News release. October 30, 2026. Accessed November 2, 2026. View source

2. FDA. FDA approves first immunotherapy for recurrent respiratory papillomatosis. News release. August 14, 2025. Accessed November 2, 2026. View source

3. Zubulake Z, Cole C. FDA Rare Disease Framework puts CMC review in scope. PharmTech.com. October 14, 2026. View source