INOVIO Pharmaceuticals, Inc. announced on April 6th that the U.S. Food and Drug Administration 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 this week. The first dosing was planned for yesterday.
Dr. J. Joseph Kim, INOVIO’s President and CEO, said, “This is a significant step forward in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing. Our dedicated team of staff, partners and funders have been mobilized since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials.”
Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), said, “This development is an important step forward in the world’s search for a COVID-19 vaccine. 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 their vaccine candidate into clinical safety testing. Producing a COVID-19 vaccine within the next 12 to 18 months is not only a scientific challenge; it will also require new levels of collaboration and investment across industry and government. There is still a long road ahead before we have a safe, effective, and globally accessible vaccine ready for broader use, but today we have reached an important milestone on that journey.”
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.
Dr. Ami Shah Brown, INOVIO’s Senior Vice President of Regulatory Affairs said, “Development and manufacture of a new vaccine with preclinical data to support a first-in-human trial in ten weeks from funding is a major milestone for INOVIO and our collaborators.”
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.
According to INOVIO, 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.
“We anticipate rapid enrollment of this initial study,” said Pablo Tebas, MD, infectious disease specialist and professor of Medicine at the Hospital of the University of Pennsylvania and Principal Investigator of the study. “There has been tremendous interest in this vaccine among people who want to do what they can to help protect the greater public from this pandemic as soon as possible.”
“INOVIO’s leadership and the team’s experience combined with the consistency of this DNA technology for clinical translation continue to be a major asset for the program,” said Dr. David B. Weiner, Director of the Wistar Institute’s Vaccine and Immunotherapy Center and Executive Vice President of the Institute.