Human testing is beginning on a second coronavirus vaccine candidate after approval from the Food and Drug Administration, Inovio Pharmaceuticals announced Monday.
The company said the first phase of clinical testing is set to begin this week with a study of 40 healthy adult volunteers.
Each participant will receive two doses of the drug, INO-4800, four weeks apart. The initial immune responses and safety data from the study are expected by late summer, according to Inovio.
Preclinical data has shown “promising immune response results across multiple animal models,” the company said in the release.
“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,” J. Joseph Kim, Inovio’s president and CEO, said in the release.
The Inovio program is supported in part by the Bill and Melinda Gates Foundation.
The drug is a DNA vaccine that is designed to prevent COVID-19 infection. Inovio said the preclinical results for the potential COVID-19 vaccine are consistent with a completed phase one vaccine study for MERS, which is also caused by a coronavirus.
Inovio said it plans to head into a second phase of the study “as rapidly as possible” and said thousands of doses of the drug have been manufactured to support ongoing phase one and phase two trials.
This is the second COVID-19 vaccine trial to be launched. A vaccine developed by the National Institutes of Health and collaborators at Moderna Inc. administered its first shot in a trial for the potential vaccine in mid-March.
The novel coronavirus is believed to have originated in China late last year and has rapidly spread around the globe, with more than 1.3 million cases confirmed worldwide and nearly 76,000 deaths from the virus, according to data compiled by Johns Hopkins University.