The U.S. Food and Drug Administration accepted Inovio Pharmaceuticals investigational new drug (IND) application for its vaccine candidate designed to prevent COVID-19 infection.
This action by the FDA paves the way for Phase 1 clinical testing of this vaccine candidate, INO-4800, in healthy volunteers beginning this week.
“This is a significant step forward in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods,” Inovio President and CEO J. Joseph Kim said. “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. Our dedicated team of staff, partners, and funders have been mobilized since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials.”
The Phase 1 study will enroll up to 40 healthy adult volunteers at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and at the Center for Pharmaceutical Research in Kansas City, Mo. Each participant will receive two doses of INO-4800 four weeks apart. Initial immune responses and safety data from the study are expected by late summer. Preclinical data has shown promising immune response results across multiple animal models.
“This development is an important step forward in the world’s search for a COVID-19 vaccine. INOVIO’s DNA vaccine platform was one of the first technologies selected by CEPI to develop a vaccine candidate against COVID-19,” Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), said. “We are pleased to see the rapid advancement of their vaccine candidate into clinical safety testing. Producing a COVID-19 vaccine within the next 12 to 18 months is not only a scientific challenge; it will also require new levels of collaboration and investment across industry and government. There is still a long road ahead before we have a safe, effective, and globally accessible vaccine ready for broader use, but today we have reached an important milestone on that journey.”
The preclinical results for Inovio’s COVID vaccine have been consistent with the company’s Phase 1 vaccine study for Middle East Respiratory Syndrome (MERS), also caused by a coronavirus. Inovio’s DNA vaccine was well tolerated and induced high levels of antibody responses in 95% of subjects, while also generating broad-based T cell responses in nearly 90 percent of study participants.
“Development and manufacture of a new vaccine with preclinical data to support a first-in-human trial in ten weeks from funding is a major milestone for INOVIO and our collaborators,” Ami Shah Brown, senior vice president of regulatory affairs at Inovio, said.
After attaining initial safety and immunogenicity data from Phase 1 studies, Inovio plans to advance INO-4800 to Phase 2 efficacy studies as rapidly as possible.