SK, Sanofi complete phase II trial for pneumococcal vaccine

SK bioscience CEO Ahn Jae-yong, left, and Thomas Triomphe, Sanofi executive vice president, pose for a photo during the Sanofi Vaccines Investor Event held in London on Thursday. [SK BIOSCIENCE]

SK bioscience and Sanofi completed the Phase II clinical trial for a pneumococcal vaccine that the companies are jointly developing, the Korean pharmaceutical company said Friday.

The SK bioscience-Sanofi 21-valent pneumococcal conjugate vaccine candidate, named GBP410, will enter Phase 3 in the first half of next year, according to the companies. The final data will be secured by 2027.

GBP410, also called SP0202 by Sanofi, is a pneumococcal conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumococcal diseases.

In the Phase 2 study that started in May 2020, SK bioscience and Sanofi found that GBP410 demonstrated comparable immunogenicity compared to the control vaccine for 140 toddlers between 12 months to 15 months old, and 712 infants aged 42 to 89 days in the United States, Canada and Honduras.

Ahead of GBP410's potential mass production in the future, SK bioscience plans to build manufacturing facilities at L House, the company’s production plant in Andong, North Gyeongsang. The facilities will comply with the U.S. Food and Drug Administration’s current Good Manufacturing Practice standard, in line with SK bioscience's goal of entering the U.S. and European markets with Sanofi.

"We're proud to collaborate with an excellent partner, Sanofi, and we continue to be committed to developing and manufacturing vaccines based our global partnerships with major pharmaceutical companies,” said SK bioscience CEO Ahn Jae-yong.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]