June 4, 2020, SEOUL, Korea and PLYMOUTH MEETING, PA, USA – The International Vaccine Institute (IVI) and Seoul National University Hospital announced a partnership to start a Phase 1/2 clinical trial of INO-4800 INOVIO’s (NASDAQ:INO) COVID-19 vaccine in South Korea at a signing ceremony today. In attendance at the ceremony at SNU Hospital were IVI’s Director General Dr. Jerome Kim and Deputy Director General of Science Dr. Manki Song, Dr. Anh Wartel (Associate Director General of EPIC and Head of Clinical Development and Regulatory) and Dr. Daniel Chul Woo Rhee (Project Lead), and SNU Hospital’s President Yon Su Kim and Prof. Myoung-don Oh.
The 2-stage trial of INO-4800, the first clinical study of COVID-19 vaccine approved in Korea, will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.
The trial, which aims to start later in June, is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) through INOVIO and is supported by the Korea Center for Disease Control and Prevention/Korea National Institute of Health. In normal circumstances, it would generally take several years to start clinical trials of a new vaccine. In the midst of the COVID-19 pandemic, however, the trial in Korea will be conducted just two months after a similar clinical study began in the United States in early April 2020.
The speedy regulatory approval was made possible thanks also to support from the Korean Ministry of Food and Drug Safety following its adoption in April of a fast-track approval process for clinical trials of COVID-19 vaccines and therapeutics that are developed with a proven safety platform. Such vaccines, including DNA vaccines, can be exempt from toxicology tests leveraging the available preclinical data using the DNA platform, and expediting clinical trial review process. The DNA vaccine of US-based INOVIO to be tested was one of the first technologies to receive support from CEPI, greatly accelerating the development process of the COVID-19 vaccine.
IVI and SNU Hospitals have collaborated in the past to conduct Phase 1/2a trials for a MERS coronavirus vaccine. The MERS vaccine (INO-4700/GLS-5300) developed by INOVIO and South Korea’s GeneOne Life Science and, in trials conducted so far, has achieved promising results.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). Headquartered in Seoul, South Korea, IVI was the first international organization hosted by Korea. IVI has 35 signatory countries and the World Health Organization (WHO) on its treaty, including Republic of Korea, Sweden and India as state funders.
Our mandate is to make vaccines available and accessible for the world’s most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, Group A Streptococcus, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int
INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure, and protect people from diseases associated with HPV, cancer, and infectious diseases. INOVIO is 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. Specifically, INOVIO’s lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. For more information, visit www.inovio.com.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.
Before the emergence of COVID-19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).
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