INOVIO received the green light for phase three of its INNOVATE Phase 2/3 clinical trial of INO-4800 last week, allowing it to proceed with efficacy evaluation of its COVID-19 DNA vaccine candidate in Brazil.
Alongside its partner, Advaccine Biopharmaceuticals Suzhou Co., Ltd., INOVIO intends to push the trial to other countries as well. In Brazil, however, it will begin enrolling candidates for a two-dose regimen, administered one month apart and randomized among men and non-pregnant women at least 18 years old. The trial’s endpoint will be virologically confirmed cases of COVID-19.
“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, president and CEO of INOVIO, 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 (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.”
Phase 2 of the trial was undertaken in the U.S., with government sponsorship. According to results pre-printed in MedRxiv prior to peer review, the candidate proved well-tolerated and immunogenic in adults. Another study demonstrated broad cross-reactive immune responses from the candidate to variants of concern, meaning it could continue usefulness as the SARS-CoV-2 virus evolves.
So far, INO-4800 has shown few side effects — most who experienced them felt mild injection site reactions. All participants in a Phase 1 trial saw overall immunological response rates and experienced balanced neutralizing antibodies and favorable T-cell responses. Highly scalable and able to be re-administered, the candidate also provides the potential benefits of thermostability, in that it can be kept at room temperature for more than a year without any need to be frozen during transport or storage. That could make it significantly more accessible for global distribution.