The United States Food and Drug Administration (FDA) has received United States-based INOVIO Pharmaceuticals, Incorporated's (NASDAQ:INO) Investigational New Drug (IND) application for INO-4800, its DNA vaccine candidate, it was reported on Monday.

The product is designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing was planned for 6 April 2020.

The Phase one study of INO-4800 is to enrol up to 40 healthy adult volunteers in Philadelphia, Pennsylvania (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, Missouri (at the Center for Pharmaceutical Research), where screening of potential participants has already started. 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 likely to be revealed by late summer. Preclinical data, which have been shared with global regulatory authorities and submitted as part of the IND and 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.