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INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate
Announcement builds on INOVIO's expanded partnership with Advaccine for INNOVATE, a global efficacy Phase 3 trial for INO-4800 INO-4800's Phase 1 and 2 trial
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Announcement builds on INOVIO's expanded partnership with Advaccine for INNOVATE, a global efficacy Phase 3 trial for INO-4800\n INO-4800's Phase 1 and 2 trial data, combined with recent findings that showed robust T cell level response against the delta variant, position it well for both primary vaccination and boosting\n\n\nPLYMOUTH MEETING, Pa. and SUZHOU, China, Aug. 9, 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 that it has received regulatory allowance for two clinical trials investigating heterologous boosting with INO-4800, its DNA vaccine candidate for COVID-19, through partner and trial-sponsor Advaccine Biopharmaceuticals Suzhou Co., Ltd. (\"Advaccine\") together with Sinovac Biotechnology (\"Sinovac\"). The studies will evaluate the safety, tolerability and immunogenicity of heterologous prime-boost sequential immunizations using INO-4800 and CoronaVac®, an inactivated COVID-19 vaccine developed by Sinovac and validated by the World Health Organization (WHO) for emergency use.\nChina's Center for Drug Evaluation of the National Medical Products Administration has allowed the initiation of two Advaccine-sponsored open-label, positive-control trials to evaluate the safety, tolerability, and immunogenicity of mixed boosted regimens. Both studies, which will be conducted in China, are anticipated to begin this fall and will involve healthy adult subjects 18 years of age or older.\nThe companies completed cross prime-boost pre-clinical animal tests using INO-4800 and CoronaVac®, demonstrating that the prime-boost strategy can stimulate high-level of antigen specific binding antibodies, neutralizing antibodies by both live-virus neutralization assay and hACE2 receptor blocking assay, and antigen-specific T cell immune responses. \nDr. J. Joseph Kim, President and CEO of INOVIO, said, \"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. 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 agains...