On Oct. 11, 2021, Inovio Pharmaceuticals announced that it had received authorization from Colombia’s INVIMA, to conduct the Phase 3 segment of INOVIO’s global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) in Colombia, for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO was working with partner Advaccine Biopharmaceuticals Suzhou on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries in Latin America, Asia, and Africa. INOVIO earlier received regulatory authorization to proceed in Brazil, Philippines, and Mexico.

The global Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed COVID-19.

INNOVATE’s Phase 3 segment builds upon the Phase 2 segment, which was conducted in the U.S. and 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. Phase 2 data was disclosed in a pre-print in MedRxiv in May 2021 and found INO-4800 to be well-tolerated and immunogenic in adults 18 and older in the trial. In another previously disclosed study using clinical samples, INO-4800 was also found to provide broad cross-reactive immune responses, including neutralizing antibodies and robust T cell responses, against variants of concern (alpha, beta, gamma and, in subsequent research, delta) – factors which could be critical in containing COVID-19 as it shifts from pandemic to endemic spread.