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INOVIO Gets Approval To Conduct Phase 3 Trial Of COVID-19 DNA Vaccine Candidate,INO-4800 In Colombia

INOVIO (INO) said Monday that it has received authorization from Colombia's INVIMA to conduct the phase 3 segment of the company's global Phase 2/3 trial, INNOVATE in Colombia, for INO-4800, its DNA vaccine candidate for COVID-19.

The company noted that it is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries in Latin America, Asia, and Africa.

INOVIO recently announced that it has 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.

INOVIO also recently announced 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.

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