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INOVIO Receives Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800
INOVIO's global Phase 3 efficacy trial receives authorization to proceed from Brazil; other countries to follow INOVIO to conduct INNOVATE Phase 3 efficacy
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"INOVIO's global Phase 3 efficacy trial receives authorization to proceed from Brazil; other countries to follow\n INOVIO to conduct INNOVATE Phase 3 efficacy trial with partner Advaccine in areas of world in need of COVID-19 vaccines\n\n\nPLYMOUTH 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).\nThe 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.\nDr. J. Joseph Kim, President and CEO of INOVIO, said, \"With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally. I am incredibly proud of the INOVIO team and grateful to the health authorities in Brazil for their commitment to advancing the fight against COVID-19. INOVIO's focus on supporting the global response to the pandemic is unwavering – and will bring forward the potential advantages of INO-4800, which in addition to being well-tolerated with balanced neutralizing antibodies and T cell responses (CD8 and CD4), has a strong thermostability profile, and potentially offers the ability to serve as both a primary as well as a booster vaccine.\"\nINOVIO's DNA medicines have shown the following overall characteristics:\nWell-tolerated and Easy to Administer: INO-4800 has a strong safety profile and, unlike other COVID-19 vaccine...