(RTTNews) - INOVIO Pharmaceuticals, Inc. (INO) announced Monday that it plans the first dose of its COVID-19 vaccine today as it initiates Phase 1 clinical efficacy trial of INO-4800, its DNA vaccine candidate, in healthy volunteers.
This follows the U.S. Food and Drug Administration's acceptance of the company's Investigational New Drug (IND) application for INO-4800 designed to prevent COVID-19 infection.
The Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers in Philadelphia and Kansas City, where screening of potential participants has already begun. Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.
Preclinical data, which have been shared with global regulatory authorities and submitted as part of the IND, 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.
Upon 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.
In 10 weeks, INOVIO has manufactured thousands of doses of INO-4800 to support on-going Phase 1 and planned Phase 2 clinical trials. In parallel, INOVIO is working to scale up the manufacturing of INO-4800.
INOVIO plans to have one million doses of the vaccine available by year-end for additional trials and emergency use, pending appropriate regulatory guidance and funding.
INOVIO's DNA vaccine platform was one of the first technologies selected by Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine candidate against COVID-19.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.