SK Bioscience has started clinical trial of GBP510

The first phase 3 of COVID vaccine developed in Korea, and 4,000 adults at home and abroad will be conducted

Phase 3 of COVID vaccine developed in Korea have begun in earnest.

 

SK Bioscience announced on the 30th that it has started administering the first subjects of phase 3 clinical trials of GBP510, jointly developed by the Institute for Protein Design (IPD) at the University of Washington.

 

This is the first phase 3 clinical trial of a candidate substance for COVID vaccine developed in Korea.

 

Previously, SK Bioscience received approval from the MFDS on the 10th for clinical trial of GBP510.

 

Phase 3 of GBP510 will be held in 14 domestic institutions, including Korea University and Guro Hospital, and 4,000 domestic and foreign adults over the age of 18 in Europe and Southeast Asia.

 

GBP510 is mixed with GSK's Pandemic Immunostimulator (Adjuvant) and is injected twice every 28 days.

 

SK Bioscience, along with the International Vaccine Institute (IVI), a non-profit international organization in East Europe and Southeast Asia, is applying for approval of each country's Phase 3 clinical trial plan.

 

It is planning to start clinical trials overseas as early as next month.

 

SK Bioscience plans to secure interim data in the first half of next year by evaluating the immunogenicity and safety of GBP510 through Phase 3 clinical trial conducted at home and abroad.

 

With prompt permission from Korean health authorities, it will also begin preparation for the WHO certification and acquisition of Emergency Use Authorization by each country.

 

SK Bioscience confirmed that as a result of Phase 1/2, Phase 1 clinical trial conducted on 80 healthy adults, 100% of neutral antibodies that neutralize COVID were formed in the dosing group that administered both GBP510 and immune enhancer.

 

This is measured through international standard substances and evaluation methods established by the WHO and the NIBSC.

 

In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510.

 

SK Bioscience is also monitoring safety of 247 participants in the second stage, which includes senior citizens.

 

No particular safety issues have occurred so far.

 

The company predicted, "When the development of the GBP510 is completed, the difficulty of supply and demand of COVID vaccine in Korea, which relies on imports, will be resolved." If GBP510 successfully enters the commercialization stage, it can establish and supply its own production and supply plan as it is a vaccine for domestic development.

 

In the long term, it is expected that it will contribute to securing vaccines as it can quickly cope with mutant viruses based on platform technology.

 

The synthetic antigen vaccine platform applied to GBP510 can be stored under refrigeration conditions of 2 to 8°C, so it can be distributed using the existing vaccine logistics network and can be stored for a long time, so it can easily secure accessibility globally.

 

GBP510 was selected as the first target of the Wave 2 project, which CEPI operated last year to support differentiated COVID vaccine candidates, and hundreds of millions of vaccinations will be supplied to the world including South Korea through the COVAX facility once the development is completed.

 

SK Bioscience' vaccine factory in Andong has the capacity to produce hundreds of millions of commercial products a year immediately after developing the vaccine and manufacturing various types of vaccines simultaneously through independent spaces in nine areas of the plant.

 

"With the rapid and systematic cooperation of health authorities and clinical institutions, we have successfully started to administer subjects.

 

We will thoroughly verify safety and effectiveness through clinical trials."