November 16, 2020 -- Inovio has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with the phase II segment of its phase II/III clinical trial for INO-4800, its COVID-19 vaccine candidate.
The Inovio INO-4800 vaccine trial for efficiency (INNOVATE) is a randomized, blinded, placebo-controlled safety and efficacy trial, funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
The phase II segment will evaluate the safety, tolerability, and immunogenicity of INO-4800 in a two-dose regimen (1.0 or 2.0 mg), in a 3:1 randomization to receive either INO-4800 or placebo for three age groups (18-50 years, 51-64 years, and 65 years and older). This segment will aim to enroll approximately 400 participants at up to 17 sites across the U.S.
The phase III segment of INNOVATE is on partial hold until Inovio satisfactorily resolves the FDA's remaining questions related to the Cellectra 2000 device that will be used to deliver INO-4800 directly into the skin. The company plans to resolve these questions during the phase II portion, prior to the start of the phase III segment.
INO-4800 is a DNA-based vaccine candidate intended to protect against SARS-CoV-2. The nucleic acid-based vaccine is stable at room temperature for more than a year and does not need to be frozen in transport or storage. Inovio is working with contract manufacturers, including Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Bioservices to manufacture INO-4800 on a commercial scale.