INOVIO Receives Regulatory Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800, in Mexico

News follows recent regulatory authorizations to proceed with the trial in Brazil and the Philippines
INOVIO and partner Advaccine are collaborating on the global Phase 3 trial in regions underserved by COVID-19 vaccines; to focus on Latin America, Asia, and Africa

PLYMOUTH MEETING, Pa., Sept. 22, 2021 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that it has 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.

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