GeneOne Life Science, Inc. announces that it has received approval from the South Korean Ministry of Food and Drug Safety (KMFDS) for an Investigational New Drug application for a Phase I/IIa study of its investigational vaccine, GLS-5300, against the Middle East Respiratory Syndrome coronavirus (MERS-CoV). The study in Korea represents the second clinical trial for GLS-5300.


A US clinical trial of GLS-5300 at the Walter Reed Army Institute of Research (NCT02670187, http://www.ClinicalTrials.Gov) has completed all study visits. GLS-5300 was well tolerated and induced high levels of antibodies and T-cell responses when administered intramuscularly (IM) and followed by electroporation (EP) using the CELLECTRA® device. All dose levels, 0.67 mg, 2 mg, and 6 mg were equally immunogenic. GLS-5300 has been shown to be fully protective in pre-clinical studies in non-human primates. The trial in Korea will assess the responses of GLS-5300 given intradermally (ID) and followed by EP at doses of 0.3 and 0.6 mg.

MERS-CoV causes a severe rapidly progressive respiratory illness. Since 2012, more than 2000 cases of MERS-CoV have been reported from 27 countries. Greater than 35% of those infected died – a mortality rate similar to the recent West African Ebola epidemic. In 2015, South Korea experienced a large outbreak of MERS-CoV emanating from a single traveler returning from a MERS-endemic country. Of the 186 people with MERS-CoV infection in Korea, 36 (19.4%) died, and 3 additional deaths reported after the epidemic. Healthcare workers, especially physicians and nurses, unfortunately represented a disproportionate number of those infected. In 2017, the Korean CDC has designated MERS-CoV as one of 10 infectious diseases with significant potential to be imported into South Korea.

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“GeneOne has been honored to have participated in the response to this deadly viral illness” states Mr. Young K. Park, CEO of GeneOne. “Regulatory approval for this Phase I/IIa clinical trial will enable GeneOne to bring the GLS-5300 MERS-CoV vaccine into Korea, a country whose citizens suffered significantly from this highly fatal infection in 2015. GeneOne is pleased to have developed a collaborative relationship with the International Vaccine Institute (IVI) that has been instrumental in bringing this clinical trial to Korea. GeneOne has maintained a focus on international infectious disease threats, including SFTS, that have affected many in Asia and Korea. GeneOne was able to respond to the MERS-CoV outbreak by bringing forward the GLS-5300 vaccine into clinical trial in 9 months. GeneOne is committed to working on the development of GLS-5300 so that it is available to Korea in the event of a future MERS outbreak.”

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GLS-5300 is the only MERS-CoV vaccine that has entered into human clinical trials to date. Through a Collaboration Agreement with IVI, funding is provided for clinical trial costs. The GLS-5300 DNA cGMP vaccine was manufactured at VGXI. GLS-5300 is being co-developed with Inovio Pharmaceuticals, Inc.