Inovio announced today that the FDA has accepted the company's IND ( new drug application) for INO-4800, the company's DNA vaccine candidate, for use against COVID-19.
The company said clinical testing will begin this week; the first dose is planned for Monday.
Inovio's CEO said in a statement, "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. 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.
According to Inovio, testing will be done in Philadelphia, the headquarters of Inovio -- which also has a San Diego presence --and in Kansas City, Missouri.
"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, said Ami Shah Brown, Inovio's senior vice president of regulatory affairs.
Phase one will involve initial safety and immunogenicty data. Then< it could move to Phase 2, efficacy studies.