FDA Grants Accelerated Approval to DNA Immunotherapy for RRP

The FDA has granted accelerated approval to Voceryq, a plasmid DNA based immunotherapy for adults with recurrent respiratory papillomatosis, according to an FDA press announcement. RRP is a rare, chronic condition caused by HPV types 6 and 11, producing wart like growths around the vocal cords that often require repeated surgical removal over many years.

Voceryq delivers two plasmids into muscle cells using the CELLECTRA 5PSP device, which applies brief electrical pulses, a method called electroporation, to help the DNA enter cells. One plasmid carries instructions for HPV proteins and the other for IL 12, an immune signaling molecule, with the goal of training the immune system to target HPV infected tissue.

The approval rests on an open label trial of 32 adults who had at least two surgeries in the prior year. Among patients with three or more baseline surgeries, 27 percent needed no surgery at all in the year after treatment. Because this is an accelerated approval based on a surrogate endpoint, the manufacturer, Inovio Pharmaceuticals, must run further trials to confirm clinical benefit. Reported side effects included injection site reactions, headache, fatigue, and dizziness related to the electroporation procedure.

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