INOVIO (NASDAQ:INO) has received accelerated approval from the US Food and Drug Administration (FDA) for VOCERYQ, a DNA-based immunotherapy designed to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP), a rare disease associated with human papillomavirus (HPV) infection.
The treatment, previously known as INO-3107, targets HPV-6 and HPV-11 and represents the first DNA medicine approved by the FDA, according to the company.
INOVIO expects VOCERYQ to become available for ordering and shipment within approximately 60 days, with a full commercial launch planned for the first quarter of 2027.
FDA Approval Supported by Phase 1/2 Clinical Results
The accelerated approval is based on results from INOVIO’s RRP-001 study, which evaluated VOCERYQ in 32 adults who had undergone at least two surgeries for RRP during the year before treatment.
The primary efficacy analysis included 26 patients who had required three or more surgical procedures in the preceding 12 months.
Among these patients, seven, or 27%, achieved a complete response, defined as requiring no surgical removal of papillomas during the 12 months following treatment.
Before receiving VOCERYQ, patients in the efficacy population had undergone a median of 4.5 surgeries during the previous year, with individual totals ranging from three to eight.
The FDA granted accelerated approval based on the complete response findings. Continued approval may depend on verification of clinical benefit in a confirmatory study.
INOVIO is required to submit a draft protocol for that study by the end of 2026, with a final protocol expected to be agreed with the FDA by mid-2027.
VOCERYQ Offers Non-Surgical Treatment Option
RRP is a condition characterised by recurring papillomas in the respiratory tract, often requiring repeated surgical procedures to manage the disease.
VOCERYQ is a plasmid DNA-based immunotherapy intended to generate an immune response against HPV-6 and HPV-11, the viruses associated with RRP.
The treatment has been approved for use with INOVIO’s proprietary CELLECTRA 5PSP delivery device.
Dr Jacqueline Shea, President and Chief Executive Officer of INOVIO, said the approval represents an important development for patients requiring repeated surgical intervention.
“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,” Shea said.
The company believes the therapy could help reduce the surgical burden associated with the disease, although its longer-term clinical benefits remain subject to confirmation.
Safety Data Show Mostly Mild or Moderate Adverse Reactions
VOCERYQ was reported to be generally well tolerated in the RRP-001 study, with all 32 participants completing treatment.
The most commonly reported adverse reactions included injection-site reactions, headaches, fatigue, hypertension, nausea and dizziness.
Most treatment-related adverse reactions were mild or moderate and temporary, according to INOVIO.
The company reported no grade 4 or grade 5 common adverse events during the study.
Clinical findings supporting the treatment’s development have been published in Nature Communications and The Laryngoscope.
Commercial Launch Planned for First Quarter of 2027
INOVIO expects VOCERYQ to be available for ordering and shipment approximately 60 days after the approval announcement.
The company anticipates deploying its full commercial field operations during the first quarter of 2027.
INOVIO has engaged Syneos Health to assist with recruiting and deploying medical and commercial teams to support the product’s introduction.
The approval establishes a commercial opportunity for INOVIO in the treatment of RRP while providing regulatory validation for its DNA medicine platform.
Outlook
The accelerated approval of VOCERYQ marks a transition towards commercialisation for INOVIO, with the company preparing to introduce its first FDA-approved DNA medicine in the United States.
The treatment provides an additional option for adults with RRP, although the FDA has required further clinical evidence to confirm its benefits.
Investors will be monitoring the planned commercial launch, initial product adoption and progress towards the confirmatory study required to support continued approval.