On Sept. 22, 2021, Inovio Pharmaceuticals announced that it had received authorization from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the national health regulatory agency of Mexico, to conduct a clinical trial in that country as part of the Phase 3 segment of INOVIO’s global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for its DNA vaccine candidate for COVID-19, INO-4800. INOVIO is working with its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the INNOVATE Phase 3 segment in multiple countries. INOVIO recently announced that it has received regulatory authorization to proceed with Phase 3 clinical trials in Brazil and the Philippines and is seeking authorization to conduct trials in additional countries.

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 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.

INOVIO also announced in August the authorization to proceed in China with two Advaccine-sponsored clinical trials investigating the safety, tolerability, and immunogenicity of heterologous boost combinations with INO-4800 and Sinovac Biotechnology’s CoronaVac^®, an inactivated COVID-19 vaccine developed by Sinovac and authorized for emergency use by the World Health Organization.

INOVIO’s DNA vaccine candidate against SARS-CoV-2, INO-4800, is composed of a precisely designed DNA plasmid that is injected intradermally followed by electroporation using a proprietary smart device, which delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response. As one of the only nucleic-acid based vaccines that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage, INO-4800 is anticipated to be well-positioned for first-in line usage as well as for boosting.