FDA Postpones Phase III Trial of Inovio’s DNA Vaccine, Delivery Device

The FDA has placed a clinical hold on a proposed Phase III trial of Inovio Pharmaceuticals’ VGX-3100, a synthetic DNA vaccine being studied in cervical dysplasia, because of questions on the delivery device for the drug.

The Cellectra 5PSP immunotherapy delivery device is designed to administer DNA immunotherapies directly into muscle tissue.

Inovio said the start of the Phase III trial could be delayed until at least the first half of 2017, pending a resolution, and expects a full formal letter from the FDA within the next 30 days.