2021. 06. 28
GBP510 submitted for Phase 3 clinical study in Korea and extend to multi-country studies
The COVID-19 vaccine to be supplied globally through COVAX Facility, if proven to be safe and effective.
The COVID-19 vaccine developed by SK bioscience (“SK”) is about to enter a phase 3 clinical trial.
SK bioscience announced on June 28 that the company has submitted the IND application for phase 3 clinical trial of ‘GBP510’ to the Ministry of Food and Drug Safety (“MFDS”), a COVID-19 vaccine candidate supported by Bill & Melinda Gates Foundation (“BMGF”) and Coalition for Epidemic Preparedness Innovations (“CEPI”) and co-developed with Institute for Protein Design (“IPD”) at the University of Washington.
This is the first time that a phase 3 IND for a COVID-19 vaccine developed in Korea has been submitted to the MFDS.
SK, in order to facilitate its development for a potential COVID-19 vaccine, has initially submitted this phase 3 IND for GBP510. After further detailed consultations with the MFDS, a full-fledged phase 3 clinical trial will be proceeded bying a final candidate in consideration of the clinical results of ‘NBP2001’, another vaccine candidate.
SK plans to apply for INDs for phase 3 clinical trial in other countries in Europe and the South East Asia in partnership with the International Vaccine Institute (“IVI”), aiming for commercialization within the first half of next year.
GBP510 wased as the first program of the Wave 2 (Next Generation COVID-19 Vaccine) project, which CEPI launched last year to support development of differentiated COVID-19 vaccine candidates that could address gaps in the current global vaccine development landscape, helping to ensure vaccines are available in the future that are easier to deliver and address the specific needs of a diverse range of populations and settings.
SK bioscience is committed to enabling global equitable access to COVID-19 vaccines and has agreed that hundreds of millions of doses of this vaccine candidate will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if proven to be safe and effective..
The Phase 3 clinical trial of GBP510 will be conducted in 4,000 adults at multi-country sites including 14 domestic institutions in Korea and will evaluate immunogenicity indicators such as neutralizing antibodies and any side effects.