FDA approval of INOVIO DNA immunotherapy

The U.S. Food and Drug Administration has granted accelerated approval to VOCERYQ (also known as INO-3107), a plasmid DNA-based immunotherapy developed by INOVIO. This marks the first time a DNA-based medicine has received FDA approval.

The treatment is indicated for adults with Recurrent Respiratory Papillomatosis (RRP), a rare disease caused by HPV-6 and HPV-11 infections that results in airway growths. Clinical data indicated that a portion of patients required no surgical intervention for 12 months following the administration of four doses using the Cellectra 5PSP delivery device. Specifically, among 26 efficacy-evaluable patients who previously required multiple surgeries, 27 percent achieved a complete response, requiring no additional surgery for 12 months following treatment.

As a condition of this accelerated approval, INOVIO is required to conduct confirmatory studies to verify clinical benefits. Additionally, the FDA has requested that INOVIO reanalyze human factors testing for the Cellectra 5PSP device and verify its sharps injury prevention features. The company expects to begin orders and shipments within approximately 60 days, with a full commercial launch planned for the first quarter of 2027.