Brazil’s national health regulatory agency recently granted authorization to INOVIO, a biotechnology company designing DNA medicines, to begin phase three of its phase 2/3 global clinical vaccine trial.
The trial is for INO-4800, its DNA vaccine candidate for COVID-19. Phase three will take place in multiple countries in partnership with Advaccine Biopharmaceuticals Suzhou Co.
“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,” Dr. J. Joseph Kim, INOVIO president and CEO, said. “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, has a strong thermostability profile, and potentially offers the ability to serve as both a primary as well as a booster vaccine.”
The trial will evaluate the efficacy of the vaccine in a two-dose regimen administered one month apart. Participants will be men and nonpregnant women 18 years of age and older on three continents.