Prime-Boost Studies Launch in China Using COVID-19 DNA Vaccine Candidate

Pennsylvania-based INOVIO announced today that it had received a regulatory allowance from China's Center for Drug Evaluation of the National Medical Products Administration for two clinical trials investigating heterologous boosting with its DNA vaccine candidate INO-4800 for the prevention of COVID-19, through partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. together with Sinovac Biotechnology.

The studies will evaluate the safety, tolerability, and immunogenicity of heterologous prime-boost sequential immunizations in adults using INO-4800 and CoronaVac®, an inactivated COVID-19 vaccine developed by Beijing, China-based Sinovac.

The companies completed cross prime-boost pre-clinical animal tests using INO-4800 and CoronaVac, demonstrating that the prime-boost strategy can stimulate a 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.

Recent analysis using clinical samples showed that INO-4800 maintained a robust T cell level against the delta variant when compared to T-cell responses from the original wildtype strain, further demonstrating INO-4800's ability to generate CD8 T cells, which INOVIO believes will be crucial in mitigating against rising variants such as delta, says INOVIO.

Dr. J. Joseph Kim, President and CEO of INOVIO, said in a related press statement, "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 against COVID-19."

"If approved, we believe INO-4800 will be well-positioned to serve the vaccine needs of the global community as both a primary and a booster vaccine due to its tolerability, balanced cross-reactive immune responses, and strong thermostability profile that does not require cold or ultra-cold-chain transport."

INOVIO previously announced the expansion of its partnership with Advaccine to jointly conduct the global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). The global INNOVATE Phase 3 efficacy segment is being prepared in multiple countries with an initial focus on Latin America, Asia, and Africa.

In parallel with INO-4800, INOVIO is also developing a novel, pan-COVID, second-generation vaccine candidate, INO-4802, which is designed to protect against current and future variants of concern.

Located in Plymouth Meeting, PA, INOVIO is a biotechnology company, the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response.