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

Excerpt from the Press Release:

PLYMOUTH MEETING, Pa., Aug. 26, 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 regulatory authorization from Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária), the national health regulatory agency of Brazil, to initiate the global Phase 3 segment of its Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO plans to conduct the global INNOVATE Phase 3 segment in multiple countries, including Brazil, with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine).

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

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