On Apr. 6, 2020, Inovio Pharma announced the U.S. Food and Drug Administration (FDA) had accepted the company’s Investigational New Drug application (NDA) for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection.

The Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers in Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun. 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 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.

To date, preclinical results for INOVIO’s COVID vaccine have been consistent with our completed Phase 1 vaccine study for Middle East Respiratory Syndrome (MERS), also caused by a coronavirus, in which INOVIO’s DNA vaccine was well tolerated and induced high levels of antibody responses in 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. Durable antibody responses to its DNA vaccine (INO-4700) used in that trial were maintained through 60 weeks following dosing.

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 from funding, 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.