Regulatory approval was granted for two new clinical trials of INO-4800 in China this week, allowing its creator INOVIO and its partners Advaccine Biopharmaceuticals Suzhou Co. Ltd. and Sinovac Biotechnology to investigate the safety, tolerability, and immunogenicity of different boosters.
INO-4800 is already undergoing a global efficacy Phase 3 trial, known as INNOVATE, but these newest trials will focus on the possibilities of prime-boost sequential immunizations for both INO-4800 and CoronaVac. CoronaVac is an inactivated COVID-19 vaccine created by Sinovac, which has already been validated by the World Health Organization for emergency use. By contrast, INOVIO’s creation is a DNA vaccine candidate.
“With the increased challenge of the highly contagious delta variant and other variants of concern around the world, our work with Advaccine and Sinovac is more important than ever,” Dr. J. Joseph Kim, president and CEO of INOVIO, said. “We are especially proud to expand on our partnership with Advaccine to explore heterologous prime-boosting using INO-4800 to protect more people in the continued fight against COVID-19. If approved, we believe INO-4800 will be well-positioned to serve the vaccine needs of the global community as both a primary and a booster vaccine due to its tolerability, balanced cross-reactive immune responses, and strong thermostability profile that does not require cold or ultra-cold-chain transport.”
The candidate has demonstrated potential in Phase 1 and 2 trials, and recent data showed it has some efficacy against the wide-spreading delta variant of COVID-19 as well. In prime-boost pre-clinical animal tests between INO-4800 and CoronaVac, the pair generated high levels of antibodies and immune responses. As overseen by the nation’s Center for Drug Evaluation, the new trials in China will be open-label and positive-control when they begin this fall. Healthy adult subjects will be enrolled, though a number has not yet been set.
“The development of heterologous prime-boost strategies for COVID-19 vaccines with different mechanisms of action is an important research direction in the field of vaccine applications,” said Dr. Bin Wang, founder and chairman of Advaccine, which is sponsoring the Chinese trials. “It provides an efficient solution to synergistically enhance the immunogenicity of vaccines, a key factor to fight against the current increase in global COVID-19 cases and variants of concern. We look forward to partnering with INOVIO and Sinovac on this important effort building on our pre-clinical work, which found that prime-boosting brings the advantages of two different vaccine applications to produce an even stronger and more balanced immune response.”