EARLY PROMISING DATA FROM THE PHASE 2 CLINICAL TRIAL OF THE VAXINE-CINNAGEN COVID-19 VACCINE
CinnaGen Co. announced that the results of preliminary analysis of data from the ongoing Phase 2 human clinical trial of the Vaxine-originated COVID-19 vaccine candidate were positive. This potential vaccine comprises a recombinant spike protein antigen formulated with Vaxine’s proprietary Advax-SM adjuvant. The Phase 2 study was a randomized, double-blind, placebo-controlled trial conducted in Iran on 400 volunteers assigned to receive two doses, 21 days apart of either Vaxine’s vaccine candidate or saline placebo in a 3:1 ratio. According to CinnaGen, the vaccine, branded as COVAX-19 by Vaxine and as SpikoGen by CinnaGen, was well tolerated in all participants and showed a promising immunogenicity profile. With early positive data from this ongoing Phase 2 study, CinnaGen now seeks to start a large Phase III clinical trial.