Phase 1 U.S. Trial of COVID-19 DNA Vaccine Enrollment Complete
Product News May 05, 2020
INOVIO recently announced that its Phase 1 U.S. clinical trial for COVID-19 DNA vaccine INO-4800 is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June. The 40 healthy volunteers now enrolled at sites at the University of Pennsylvania in Philadelphia, PA, and a clinic in Kansas City, MO, will receive two doses of INO-4800 four weeks apart. The Phase 1 study is designed to assess the safety profile and immunogenicity of INO-4800 in support of advancing rapidly to a Phase 2/3 efficacy trial, which is planned to potentially initiate this summer.
Dr. J. Joseph Kim, INOVIO's President and CEO, said, "We are extremely grateful to the volunteers in Philadelphia and Kansas City who have stepped forward in the midst of this deadly pandemic to help advance our promising DNA vaccine against COVID-19. Without these volunteers, we would not be able to advance the clinical study of INO-4800 at record speed and potentially provide INO-4800 as a viable vaccine against the global COVID-19 pandemic."
Working in parallel with the clinical trial program in humans, INOVIO is conducting several challenge studies in multiple animal models in collaborations with some of the leading research groups in the world – as well as working to scale up manufacturing of INO-4800. Preclinical data have shown that INO-4800 resulted in promising immune responses across multiple preclinical models, and the company is on track with its plan to deliver one million doses by year-end for additional studies and potential emergency use, pending appropriate regulatory guidance and external funding.
Lead Principal Investigator of the U.S. Phase 1 INO-4800 study Pablo Tebas, M.D., infectious disease specialist and Professor of Medicine at the Hospital of the University of Pennsylvania, said, "We anticipated rapid enrollment of this study and the response at both our Philadelphia and Kansas City study sites exceeded all expectations. We are profoundly inspired by this level of volunteerism for the greater good as well as grateful to our dedicated team of health care professionals for their tireless dedication to this worldwide effort."
INOVIO has assembled a global coalition of collaborators, partners, manufactures, and funders to rapidly advance INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, Université Laval, and the University of Texas. INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm, and Ology Biosciences to produce an anticipated one million doses of INO-4800 by year end and seeking additional external funding and partnerships to scale up manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine. To date, CEPI, the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.
INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was rapidly designed using INOVIO's proprietary DNA medicine platform after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).