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INOVIO Further Expands INNOVATE Phase 3 Trial for COVID-19 DNA Vaccine Candidate INO-4800 With Regulatory Authorization from India
Authorization to conduct INNOVATE Phase 3 trial in India builds on recent regulatory authorizations from Brazil, Philippines, Mexico and Colombia PLYMOUTH
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Authorization to conduct INNOVATE Phase 3 trial in India builds on recent regulatory authorizations from Brazil, Philippines, Mexico and Colombia\n\n\nPLYMOUTH MEETING, Pa., Nov. 3, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases, and help treat cancer, and HPV-associated diseases, today announced that it has received authorization from India's Central Drugs Standard Control Organization (CDSCO)'s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), in India for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico and Colombia.\nThe 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 symptomatic COVID-19.\n\"As COVID-19 continues to threaten the health and safety of the global population, and many areas of the world are still awaiting sufficient access to safe and effective vaccines, INOVIO is pleased to receive regulatory authorization to proceed with our efficacy Phase 3 trial in India,\" said Dr. J. Joseph Kim, President and CEO of INOVIO. \"INOVIO remains steadfast in its mission to fight COVID-19 through the development of INO-4800, which is designed to serve the needs of those in India and beyond, as both a primary series and a booster vaccine.\" \nINNOVATE's Phase 3 segment builds upon the Phase 2 segment, which was conducted in the U.S. and funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency. Interim Phase 2 data from the ongoing study was disclosed...