Jinwon Life Sciences Completes World's First MERS Vaccine Phase 2 Clinical Trial in Korea
[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 18th that it has reported the completion of the Phase 1/2a clinical trial of the MERS DNA vaccine (GLS-5300), conducted domestically in collaboration with the International Vaccine Institute (IVI), to the Ministry of Food and Drug Safety.
Park Young-geun, CEO of GeneOne Life Science, stated, “The Phase 1/2a clinical trial of the MERS DNA vaccine (GLS-5300) was conducted with support from the Samsung Life Public Welfare Foundation through the International Vaccine Institute (IVI), marking the world’s first completion of a Phase 2 clinical trial for a MERS vaccine domestically by Korean researchers.”
He added, “In the event of another MERS crisis in Korea, we will be able to respond swiftly through emergency use authorization.”
Joel Maslow, Chief Medical Officer (CMO) of GeneOne Life Science, said, “The interim analysis results of the Phase 1/2a clinical trial of the MERS DNA vaccine (GLS-5300) confirmed safety with no issues for administration to the general public, and demonstrated the vaccine’s ability to induce an immune response effective against MERS. A two-dose regimen of 0.6mg induced an 88% seroconversion rate, and 92% of vaccine recipients produced neutralizing antibodies that suppress the MERS virus.”
He emphasized, “Even a single vaccine dose generated binding antibodies in 74% of recipients and neutralizing antibodies in 48%.”
The research results were also presented at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) at 4:45 PM Eastern Time on the 14th.
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The MERS DNA vaccine (GLS-5300), jointly developed by GeneOne Life Science and Inovio, completed a Phase 1 clinical trial at the Walter Reed Army Institute of Research under the U.S. Department of Defense, with results published in the international medical journal Lancet Infectious Diseases. In September 2017, it received approval from the Ministry of Food and Drug Safety and conducted Phase 1/2a clinical studies at Seoul National University Hospital and Bundang Seoul National University Hospital.
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