FLC | Funding for second COVID-19 vaccine trial includes $11.9m from DoD

Funding for second COVID-19 vaccine trial includes $11.9m from DoD

April 7, 2020

INOVIO Pharmaceuticals, Inc. announced on April 6 that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning that week. The first dosing was planned for the same day as the announcement.

Plymouth Meeting, Pennsylvania-based INOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance INO-4800; this coalition includes the US Department of Defense (DoD). The scientific team at the Wistar Institute has provided key research contributions. The INOVIO program has been supported by generous funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation. VGXI, Inc., a wholly-owned subsidiary of GeneOne Life Science, enabled the expedited manufacture, testing, and release of the INO-4800 plasmid clinical product. On March 24, the DoD awarded an $11.9-million contract to INOVIO's collaborator Ology Bioservices of Alachua, Florida, to manufacture additional doses of INO-4800. The companies are being supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.

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.