SK bioscience announced positive results from its Phase II clinical trials in infants of its 21-valent pneumococcal conjugate vaccine candidate, 'GBP410' (also known as SP0202), evaluating its safety and immunogenicity. GBP410, jointly developed by SK bioscience and Sanofi, is a pneumococcal conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumococcal diseases such as pneumonia and invasive pneumococcal disease. The pneumococcal conjugate vaccine is well known to provide the effective protection against pneumococcal infections among the pneumococcal vaccines developed to date.

Given that GBP410 includes 21 serotypes, it is anticipated to offer broader serotype coverage than the existing pneumococcal conjugate vaccines that currently dominate the global market. If successfully commercialized, GBP410 is expected to rapidly increase market share by leveraging Sanofi's marketing expertise as the industry leader in the pediatric vaccine market. The Phase II study, which enrolled 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89 days, demonstrated comparable immunogenicity of GBP410 compared to the control vaccine, following the primary vaccination at 2, 4, and 6 months of age as well as the booster vaccination for ages of 12 to 15 months.

This study was conducted in the United States, Canada, and Honduras and it commenced in May 2020. The data also showed a well-tolerated safety profile, with comparable reactogenicity profile to the control vaccine and no vaccine-related serious adverse events. Furthermore, GBP410 did not interfere with the immunogenicity and safety profile of the co-administered recommended pediatric vaccines, such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b vaccines.

Based on the positive safety and immunogenicity data from the Phase II clinical trial, SK bioscience and Sanofi plan to start Phase III in H1 2024, expecting to secure the final data in 2027. In preparation for the commercialization of GBP410, SK bioscience intends to enter the U.S. and European markets with Sanofi by making significant investments in manufacturing facilities. The company will establish production facilities at L HOUSE, its vaccine manufacturing plant in Andong, Korea, ensuring compliance with the FDA's current Good Manufacturing Practice (cGMP) standards.