Inovio, Advaccine To Conduct Phase 3 Trial Of COVID-19 DNA Vaccine Candidate

Inovio Pharmaceuticals Inc. (INO) said that it has expanded partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to conduct global phase 3 efficacy trial of COVID-19 DNA vaccine candidate, INO-4800.

The phase 3 efficacy trial is planned to commence this summer in areas of the world underserved by vaccines.

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.
As per the expanded collaboration, INOVIO and Advaccine intend to share equally the total cost of the planned global Phase 3 trial, which is estimated to be approximately $100 million. 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. Advaccine has extensive experience in co-development of INO-4800 with INOVIO, including sponsoring both Phase 1 and Phase 2 clinical trials in China for INO-4800.

In addition to the initiation of the clinical trial itself, INOVIO said it 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.

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