First U.S. DNA immunotherapy: FDA clears drug against recurring airway growths
Inovio's Voceryq is meant to reduce the number of surgeries for adults with respiratory papillomatosis. The approval is accelerated and tied to a further study.
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The U.S. Food and Drug Administration on Oct. 30 granted accelerated approval to Voceryq (INO-3107) from biotech company Inovio. It is the first plasmid DNA-based immunotherapy approved in the United States. It treats adults with recurrent respiratory papillomatosis (RRP): in this rare disease, benign growths repeatedly form in the larynx and airways and have to be removed surgically – each time with a risk of injuring the larynx.
Voceryq contains two circular pieces of DNA: one carries the blueprint for antigens of human papillomaviruses HPV-6 and HPV-11, the other for the immune-boosting messenger IL-12. It is injected into muscle; a device called Cellectra uses electroporation – short electrical pulses – to help the DNA enter cells. Treatment spans nine weeks.
In the open-label RRP-001 study without a control group, 7 of 26 patients who previously had at least three surgeries a year needed no procedure in the following 12 months (27 percent). The most common side effects were injection-site reactions, headache and fatigue. Because of the accelerated pathway, Inovio must confirm the benefit in a confirmatory trial; the company plans to submit a draft protocol to the FDA by the end of 2026. The shares jumped 257 percent in extended trading.