- Source : Press Release
- Date : 2022-04-25
- Event type : Phase 3
- Companies : SK Bioscience Co. Ltd., GlaxoSmithKline Plc
SK Bioscience Gets P3 Clinical Results for Covid-19 Vaccine
SK Bioscience said that it has secured excellent phase 3 clinical results for GBP510, its Covid-19 vaccine.
SK Bioscience conducted phase 3 clinical trials in 4,037 adults over 18 at 16 clinical institutions in Korea, including Korea University Guro Hospital, and five overseas countries -- Thailand, Vietnam, New Zealand, Ukraine, and the Philippines.
As a result, the company confirmed that GBP510 demonstrated immunogenicity superiority compared to Vaxzevria, the control vaccine jointly developed by Oxford University and AstraZeneca.
According to SK Bioscience, the company confirmed that GBP510 showed the superiority of significantly increasing neutralizing antibodies compared to control vaccines.
The antibody conversion rate, which refers to the proportion of clinical subjects whose neutralizing antibody level increased fourfold or more, was significantly higher in the GBP501 group than that of the control vaccine.
The company expects to secure safety data this month and submit it for product approval after securing the safety data.
If authorized by the health authorities, the company expects to help Korea become a vaccine sovereign country while raising its status to an independent exporter of a Covid-19 vaccine.
"Through the successful development of GBP510, we will create a new turning point in global quarantine," SK Bioscience CEO Ahn Jae-yong said. "We will also do our best to help Korea establish itself as a vaccine sovereign country."
GBP510 is a Covid-19 vaccine candidate jointly developed by SK Bioscience and the Institute for Protein Design (IPD) of the University of Washington and used GSK's adjuvant. The development process was supported by the Bill & Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Prevention and Innovation (CEPI).