New COVID-19 Drug Backed by Bill Gates Entering Human Trials
A possible vaccine against COVID-19 is entering Phase 1 clinical human trials in the U.S. Inovio Pharmaceuticals said the U.S. Food and Drug Administration has accepted the company's Investigational New Drug (IND) application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection.
According to a press release from Inovio, the Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers in Philadelphia, Pennsylvania and Kansas City, Missouri. Study supplies of INO-4800 arrived at the sites last week.
Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.
Inovio added that preclinical data, which have been shared with global regulatory authorities and submitted as part of the IND, have shown “promising immune response results across multiple animal models.”
Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial.
The pharmaceutical and biotechnology company said that it had already completed Phase 1 vaccine study for Middle East Respiratory Syndrome (MERS), also caused by a coronavirus. Inovio said its DNA vaccine was “well tolerated and induced high levels of antibody responses in 95 percent of subjects, while also generating broad-based T cell responses in nearly 90 percent of study participants.”
"This is a significant step forward in the global fight against COVID-19,” said Dr. J. Joseph Kim, Inovio’s President and CEO. “Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing.”
Inovio said its program has been supported by generous funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation.