[Photo provided by SK Bioscience Co.]
SK Bioscience has filed for an IND (Investigational New Drug) application with the Ministry of Food and Drug Safety for a Phase 3 clinical trial of its Covid-19 vaccine candidate, becoming the first Korean name entering the final stage before commercialization of a vaccine to fight pandemic.
The company said in a regulatory filing Tuesday that the vaccine trial protocol of GBP510 was submitted for regulatory review.
SK Bioscience’s GBP510 is a coronavirus vaccine candidate jointly developed with the Institute for Protein Design (IPD) at the University of Washington with support from Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).
The global multicenter Phase 3 clinical trial aims to evaluate the vaccine’s efficacy and safety in some 4,000 healthy volunteers.
SK Bioscience said it is speeding up the vaccine development speed and a full-fledged Phase 3 clinical trial will begin in consideration with the progress of NBP2001, another coronavirus vaccine being developed by SK Bioscience.
By Park Yoon-gyun and Minu Kim
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