FDA grants accelerated approval to Inovio's VOCERYQ for recurrent respiratory papillomatosis

The approval

The FDA granted accelerated approval to VOCERYQ for adults with recurrent respiratory papillomatosis, or RRP. The drug was previously called INO-3107. Inovio calls it the first FDA-approved DNA medicine. VOCERYQ is Inovio's first approved product. The approval covers use with Inovio's CELLECTRA 5PSP device, which injects the treatment into muscle and applies short electrical pulses intended to help the DNA enter cells.

The indication is to reduce the frequency of surgical papilloma excisions. It was granted under the accelerated approval pathway based on a complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population. Continued approval may depend on verification of clinical benefit in a confirmatory study. The FDA previously granted VOCERYQ Orphan Drug and Breakthrough Therapy designations.

The approval gives adults with RRP a drug cleared to reduce the number of operations they need.

What RRP is

RRP is a rare disease caused mainly by HPV types 6 and 11. It produces recurring, usually non-cancerous growths in the airway, often on the vocal cords. Many patients need repeated operations to protect their breathing and voice. Surgery removes the growths but does not clear the underlying viral infection, leaving many patients dependent on repeated procedures for years.

VOCERYQ is a plasmid DNA-based immunotherapy designed to stimulate an immune response against HPV-6 and HPV-11. Inovio said the most common adverse reactions were injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Most treatment-related reactions were grade 1 and 2 and transient, and all 32 patients in the study completed it.

The 26 patients behind the approval

The RRP-001 study was open-label and enrolled 32 adults who had undergone at least two surgeries in the year before treatment. Twenty-six of those 32 had needed three or more surgeries and formed the efficacy population. The median in that group was 4.5 surgical excisions in the 12 months before the first dose, with a range of 3 to 8.

Seven of the 26, or 27%, needed no surgical excision of papillomas in the 12 months after treatment. The 95% confidence interval ran from 12% to 48%. Inovio says that result is not expected as part of the natural history of the disease when untreated. Nature Communications and The Laryngoscope published the clinical data.

Price and launch

Inovio set a list price of $115,000 per dose, or $460,000 for the four-dose series, according to the Philadelphia Business Journal. That matches Precigen's Papzimeos, the only other approved RRP drug. Patients' actual costs will depend on insurance. Inovio expects insurers covering about 80% of US patients to set coverage policies within nine months.

Inovio expects VOCERYQ to be available to order and ship in about 60 days, with full commercial launch in the first quarter of 2027. Syneos Health is building a 20-territory field team aimed at roughly 400 laryngologists, with full deployment expected in early 2027. Syneos will recruit and deploy medical science liaisons as Inovio's contract sales organisation in the US. Inovio has also engaged or identified a third-party logistics provider, a specialty distributor, a specialty pharmacy and a patient hub.

Cash and share price

Inovio expects its cash, cash equivalents and short-term investments to fund operations into late first quarter 2027. Chief executive Jacqueline Shea said more capital will be needed.

Shares closed at $1.89 on Monday 2 November, up about 214% from Friday's close of roughly 60 cents, the Philadelphia Business Journal reported. HC Wainwright upgraded the stock to buy with a $5 price target. Seeking Alpha published an upgrade from Hold to Buy, citing the approval and the risk attached to the confirmatory trial.

What happens next

Inovio must submit a draft protocol for the confirmatory study by the end of 2026, with a final protocol agreed with the FDA by mid-2027. Inovio reports quarterly earnings on 10 November. Shea said the company will also explore treating children and pursue markets including the European Union and the United Kingdom.