INOVIO, a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced it has dosed its first subject in a Phase 2 clinical trial evaluating DNA medicine INO-4800, its COVID-19 vaccine candidate, as part of its Phase 2/3 clinical trial, called INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy). The Phase 2 segment of the trial will enroll approximately 400 participants who are 18 years or older at up to 17 U.S. sites to evaluate safety and immunogenicity in order to confirm the dose(s) for the subsequent efficacy evaluation as part of the Phase 3 segment of the trial. INOVIO plans to fully enroll the Phase 2 segment of the trial by the end of this month.
INNOVATE is a randomized, blinded, placebo-controlled safety and efficacy evaluation of INO-4800 being conducted in adults in the U.S. The INNOVATE trial is funded by the U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA).
Dr. J. Joseph Kim, INOVIO's President & CEO said, "We're pleased to move into the Phase 2 segment of our 2/3 trial on the pathway to establish our DNA technology as an integral component of the pandemic response given its potential for an outstanding safety profile and its demonstrable thermostability. I am particularly grateful for the confidence instilled in us by the U.S. Department of Defense, a partnership to ensure that healthcare workers, frontline responders, our elderly as well as our military servicemembers are protected from COVID-19."
The Phase 2 segment of the trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one randomization to receive either INO-4800 or placebo to confirm the more appropriate dosing level(s) for each of three age groups (18-50 years, 51-64 years and 65 years and older) at high risk of SARS-CoV-2 exposure for the subsequent Phase 3 efficacy evaluation.
The DoD has agreed to provide funding for both the Phase 2 and Phase 3 segments of INNOVATE, in addition to the $71 million of funding previously announced in June for the large-scale manufacture of the company's proprietary next generation smart device CELLECTRA® 3PSP and the procurement of CELLECTRA® 2000 devices.
About the INO-4800 "INNOVATE" Phase 2/3 Clinical Trial
The lead Principal Investigator for INNOVATE is Dr. Pablo Tebas, Professor of Medicine at the Hospital of the University of Pennsylvania. The Phase 2 segment of the trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one randomization to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation. The company strives to ensure diversity in enrollment, targeting specific populations that are working or residing in environments with high risk of exposure to SARS-CoV-2, for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings.
The Phase 3 segment of the INNOVATE remains on partial clinical hold until INOVIO satisfactorily resolves the FDA's remaining questions related to the CELLECTRA 2000 device that will be used to deliver INO-4800 into the cells of the skin. The company plans to satisfy the remaining device questions during the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of INNOVATE. In the Phase 3 segment of the trial, INOVIO intends to enroll healthy men and non-pregnant women 18 years and older, to evaluate the efficacy of the proposed dosing level(s) for each age group based on the data from the Phase 2 evaluation. Participants will be enrolled in a one-to-one randomization to receive either INO-4800 or a placebo. The Phase 3 segment will be case-driven with the final n...
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