INOVIO greenlit for Phase 3 trial of COVID-19 vaccine candidate INO-4800

With approval from the U.S. Food and Drug Administration (FDA) now in hand, INOVIO intends to proceed with a Phase 3 segment of its INNOVATE trial for the COVID-19 vaccine candidate INO-4800 in the United States.

Authorization followed a partial clinical hold on the candidate, while the FDA reviewed additional non-clinical, clinical, and device information provided by INOVIO. However, the company progressed authorization pushes elsewhere worldwide, even during its U.S. pause, in Brazil, Colombia, Mexico, the Philippines, and Thailand.

“I want to recognize and express my appreciation to my INOVIO colleagues for their hard work throughout this process,” Dr. J. Joseph Kim, INOVIO president and CEO, said. “We are pleased to have the opportunity for U.S. clinical trial participants to potentially contribute to the enrollment in our INNOVATE Phase 3 segment.”

As to the INNOVATE trial, Phase 3 will be run via a collaboration between Advaccine Biopharmaceuticals Suzhou Co. Ltd. and INOVIO. Though it can now proceed in the U.S., it also has segments in Asia and Africa as well, all dedicated to evaluating the efficacy of INO-4800 as a two-dose regimen, spaced one month apart. For the moment, its focus is on non-pregnant adults.

The primary endpoint for the trial will be reached when it virologically confirms symptomatic COVID-19 cases.