Inovio Pharmaceuticals reported that the FDA has signed off on a Phase I trial of INO-4800, its experimental DNA vaccine candidate designed to prevent COVID-19 infection, with the first dosing planned for Monday. CEO J. Joseph Kim remarked "this is a significant step forward in the global fight against COVID-19," adding that "it also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase I clinical testing."
The study will enroll up to 40 healthy adult volunteers in Philadelphia, PA, and Kansas City, MO, where screening of potential subjects has already started. Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data are expected by late summer. Inovio also pointed to preclinical data for INO-4800 showing "promising immune response results across multiple animal models," adding that findings so far "have been consistent" with a completed Phase I study of its INO-4700 vaccine for MERS, which is also caused by a coronavirus. The company noted that "durable antibody responses" to INO-4700 in that trial were maintained through 60 weeks following dosing. Meanwhile, additional preclinical trials for INO-4800, including challenge studies, will continue in parallel with the Phase I clinical trial.
Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), said Inovio's "DNA vaccine platform was one of the first technologies selected  by CEPI to develop a vaccine candidate against COVID-19. We are pleased to see the rapid advancement of [INO-4800] into clinical safety testing." The company has also received financial backing from the Bill and Melinda Gates Foundation to test and scale up the CELLECTRA 3PSP smart device for the intradermal delivery of INO-4800.
Inovio said that upon attaining initial safety and immunogenicity data from Phase I studies, it plans to advance INO-4800 to mid-stage testing "as rapidly as possible." The company noted that in 10 weeks from funding, it has manufactured "thousands of doses of INO-4800 to support on-going Phase I and planned Phase II clinical trials." It added that it is also looking to ramp up manufacturing of INO-4800, and anticipates having "one million doses of the vaccine available by year-end for additional trials and emergency use."
Meanwhile, a Phase I study of Moderna's experimental mRNA vaccine mRNA-1273 against SARS-CoV-2, partnered with the National Institute of Allergy and Infectious Diseases, dosed its first patient in the US in mid-March.