With funding from the U.S. Department of Defense (DoD) and clearance from the U.S. Food and Drug Administration (FDA), Inovio Pharmaceuticals signaled intentions to begin phase two of its Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate.
“Initiation of our Phase 2 trial marks a pivotal milestone for INO-4800,” Inovio President and CEO J. Joseph Kim said. “We are especially pleased to continue our partnership with the DoD to advance the development of INO-4800 for active duty service members and civilian personnel and are grateful for the Department’s continued confidence in our technology to combat COVID-19.”
The trial will be called INNOVATE and will be randomized, blinded, and placebo-controlled, consisting of approximately 400 patients divided into three age groups of volunteers with high risks of infection: 18-50 years, 51-64 years, and 65 years and older. The drug has already proven capable of manufacture and transport without frozen cold chain requirements, a major hurdle that can prevent vaccines from wider use.
Authorization was granted based on non-clinical data, device information, and interim phase one safety and immunogenicity data, along with the plans Inovio has produced for planned trials. Up to 17 sites in the United States will host the phase two trial, which will focus on evaluating safety and immunogenicity. These should confirm the doses needed for a phase three segment of the trial.
However, a phase three trial remains on hold until Inovio addresses FDA questions on its CELLECTRA 2000 device, which it intends to use to inject INO-4800 into the skin. These questions should be resolved by the end of phase two.