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INOVIO Expands Partnership with Advaccine to Conduct Global Phase 3 Efficacy Trial of COVID-19 DNA Vaccine Candidate, INO-4800
Phase 3 efficacy trial planned to commence this summer in areas of the world underserved by vaccines News follows recently announced Phase 2 data, which
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 3 efficacy trial planned to commence this summer in areas of the world underserved by vaccines\n News follows recently announced Phase 2 data, which showed INO-4800 to be well-tolerated and immunogenic in all age groups\n\n\nPLYMOUTH MEETING, Pa., June 8, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), 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, today announced an expansion of its previously announced partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (\"Advaccine\") 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.\nDr. 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.\"\nDr. Kim continued, \"We believe that INO-4800, if approved, will be well-positioned to serve the vaccine needs of the global community. Based on trial results to date, this vaccine has shown to be well-tolerated; produces balanced neutralizing antibodies and favorable T cell response (CD8 and CD4) and is easy to administer. It is uniquely positioned to support vaccine rollout to underserved countries globally with a strong thermostability profile that is s...