INOVIO, 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, announced an expansion of its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). 

Together, the companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in subjects 18 years and older across several countries, primarily in Latin America and Asia. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. The 2.0 mg dose was selected from the Phase 2 segment, where INO-4800 was shown to be generally well-tolerated and immunogenic in all tested age groups.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "With most countries in the world currently registering COVID vaccination rates of less than 10%, INOVIO and Advaccine feel the urgency to advance INO-4800 into a global Phase 3 trial this summer. INOVIO is encouraged by our recently published Phase 2 data for INO-4800, which showed the vaccine to be well-tolerated and immunogenic in all tested age groups. In a previously announced study, INO-4800 was also found to generate broad cross-reactive immune responses against tested SARS-CoV-2 variants of concern, which may enable it to provide greater protection for more people globally."

Dr. Kim continued,”[This vaccine] is uniquely positioned to support rollout to underserved countries globally with a strong thermostability profile that is stable at room temperature for more than a year and does not require cold or ultra-cold-chain transport. In addition to the potential approval as a primary vaccine, INO-4800 also has the potential to be used as a booster vaccine since the early clinical data supports that INO-4800 can be safely re-administered."