Inovio announced Monday 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 immunogenicity data. Then it could move to Phase 2, efficacy studies.
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