IVI, INOVIO, and KNIH to partner with CEPI in Phase 1/2 clinical trial of INOVIO’s COVID-19 DNA vaccine in South Korea

The International Vaccine Institute (IVI) announced today that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO ( to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO’s COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to INOVIO’s Phase 1 INO-4800 study currently underway in the US since April 6, 2020 with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults.

Dr. Jerome H. Kim, Director General of IVI, said, “Vaccines are the long-term solution to controlling the COVID-19 pandemic. The rapid global response to developing vaccine candidates has been a profound demonstration of governments, industry, and the scientific community coming together to confront a common crisis, and we’re looking forward to accelerating one of those candidates through clinical testing. IVI has achieved promising trial results with INOVIO’s DNA vaccine platform in the past, and we’re pleased to partner again to test the safety and immunogenicity of an urgently needed COVID-19 vaccine.”

Dr. J. Joseph Kim, INOVIO’s President and CEO, said, “Developing a safe and effective COVID-19 vaccine is a global imperative, and we’re pleased to partner with IVI and KNIH to test INO-4800 in South Korea. Our DNA vaccine platform was one of the first technologies to receive support from CEPI to accelerate a COVID-19 vaccine, and IVI conducting safety and efficacy trials in South Korea is a crucial step forward in evaluating this vaccine.”

Dr. Richard Hatchett, CEO of CEPI said, “Developing a safe and effective vaccine and ensuring its global supply is our best exit strategy from the COVID-19 pandemic. CEPI is pleased to work with INOVIO and IVI in this critical next stage of testing.”

INOVIO’s DNA vaccine platform is also utilized in their MERS vaccine, INO-4700, for which IVI previously conducted Phase I clinical testing with GeneOne Life Science in South Korea.

This news follows the announcement from the Korean Ministry of Food and Drug Safety made on April 13th that they will adopt a fast-track approval process for COVID-19 vaccine and treatment clinical trials. The period of clinical trial screening will be shortened to seven days (down from 30 days) for substances with experience in use and within 15 days for new materials. Additionally, vaccines developed with a proven safety platform, such as INOVIO’s DNA platform, will be exempt from toxicology tests which will minimize data submission and expedite clinical trials. Plumbline Life Sciences of South Korea also collaborated on this project. Korea Centers for Disease Control and Prevention (KCDC) and the KNIH and has also pledged their support for IVI’s testing efforts.

INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, the University of Texas, Twist Biosciences, and the Lavalle University. INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm, and Ology Biosciences to produce up to one million doses of INO-4800 by year end and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy urgent global demand for safe and effective vaccine. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.

 

Via INOVIO

 

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