Inovio Pharmaceuticals, Inc. [NASDAQ: INO] share has skyrocketed 2.16% during the pre-market trading session after the firm disclosed that it has won the approval to carry out a clinical study in that country as part of the Phase III segment of INOVIO’s global Phase 2/3 trial, INNOVATE, for its DNA vaccine candidate for COVID-19, INO-4800.
The authorization for INO’s COVID-19 vaccine candidate is provided by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) which is the national health regulatory agency of Mexico. INOVIO is closely working with its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries. INNOVATE is the INOVIO INO-4800 Vaccine Trial for Efficacy.
Furthermore, the worldwide Phase III segment of INNOVATE will assess the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose). The doses will be inoculated one month apart, in 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase III study is virologically confirmed COVID-19.
Additionally, the Phase III segment of INNOVATE is based on the Phase II segment. The Phase II stage was carried out in the U.S. and financed by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in collaboration with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
INOVIO also disclosed in August the approval to work in China with two Advaccine-sponsored clinical studies assessing 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.