INOVIO To Begin Phase 2 Of Its Phase 2/3 Clinical Trial For COVID-19 DNA Vaccine Candidate

(RTTNews) - Biotechnology company Inovio Pharmaceuticals Inc. (INO) announced Monday that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate.

The planned Phase 2/3 clinical trial, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 to be conducted in adults in the U.S.

The Phase 2 segment of the trial is expected to enroll approximately 400 participants at up to 17 U.S. sites to evaluate safety and immunogenicity in order to confirm the dose(s) for the subsequent efficacy evaluation planned for the Phase 3 segment.

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 for each dose to confirm the more appropriate dose(s) for each of three age groups with high risks of infection (18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation.

The Phase 3 segment of the INNOVATE trial remains on partial clinical hold. The U.S. Department of Defense (DoD) has agreed to provide funding for both the Phase 2 and Phase 3 segments of the INNOVATE clinical trial.