INOVIO has expanded 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). 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 trial 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.
 
Under the expanded collaboration, INOVIO and Advaccine intend to share the total cost of the planned global Phase 3 trial, which is estimated to be approximately $100 million. The existing relationship between the two companies includes an exclusive agreement under which Advaccine has the exclusive rights to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of mainland China, Hong Kong, Macao and Taiwan. Under the expanded agreement, Advaccine obtains rights to additional Asian countries outside of Greater China.
 
The global Phase 2/3 trial builds upon INOVIO’s Phase 2 segment, which was funded by the U.S. Department of Defense.
 
INOVIO is in discussions with several countries which are expected to provide clinical trial sites, regarding advanced market contracts to potentially supply INO-4800 upon respective regulatory approvals in those countries.