Inovio has secured accelerated approval from the US Food and Drug Administration (FDA) for Voceryq to minimise the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).
Caused by HPV-6 and/or HPV-11 primarily, RRP is characterised by the development of wart-like growths in the respiratory tract.
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The DNA-based immunotherapy, generically known as doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd and previously designated INO-3107, was cleared under the FDA’s accelerated approval pathway.
The approval was based on demonstrated complete response, defined as patients requiring no surgical intervention in the 12 months following treatment.
Continued approval may depend on verification of clinical benefit through a confirmatory study.
Inovio president and CEO Dr Jacqueline Shea said: “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.”
Data from Inovio’s RRP-001 trial of Voceryq underpinned the regulatory decision. The study enrolled 32 adult patients who had undergone at least two papilloma excision surgeries in the preceding year.
Of these, 26 patients who had required three or more surgeries during the prior 12 months formed the efficacy population, with a median of 4.5 prior surgical excisions.
Seven of the 26 efficacy patients, or 27%, achieved a complete response after 12 months of follow-up, requiring no further surgical excision. This outcome is not expected in the natural history of untreated disease. No additional surgical excisions were required during the dosing window under the study protocol.
The treatment was well tolerated across the trial. The most common adverse reactions, occurring in more than 5% of patients, included injection site reactions, fatigue, headache, hypertension, dizziness and nausea.
Most treatment-related adverse reactions were classified as grade 1 or 2 and were transient, with no grade 4 or 5 common adverse events reported. All patients completed the trial.
Voceryq was approved for use alongside Cellectra 5PSP, Inovio’s DNA medicine delivery device. The company expects the product to be available for ordering and shipment within approximately 60 days, with full commercial deployment anticipated during the first quarter of 2027.
Inovio has engaged Syneos Health to support its medical and commercial field teams.
Inovio is required to submit a draft protocol to the FDA for a confirmatory study by the end of 2026, with the aim of finalising the protocol by mid-2027.
