Positive Safety, Immunogenicity Data
SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, today 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.
Jean-Francois Toussaint, Global Head of Vaccines R&D at Sanofi said, “We are pleased with our very productive partnership with SK bioscience as we work to raise the bar in pneumococcal disease. With an innovative carrier that breaks the glass ceiling of serotype compositions, our 21-valent pneumococcal conjugate vaccine is designed to offer expanded protection against this devastating disease. We believe that today’s results offer us a strong path to Phase 3 and then to licensure.”
Jaeyong Ahn, CEO of SK bioscience said, "The successful Phase II clinical trials of pneumococcal conjugate vaccine signifies that SK bioscience’s technology and capability in vaccine development can deliver best in class vaccine candidates,” adding, “We’re so proud to collaborate with an excellent partner, Sanofi, and we continue to be committed to developing and manufacturing vaccines based on the global partnership with major pharmaceutical companies.”
SK bioscience is accelerating to expand the global market through various global partnerships. The company seeks the key technologies for mRNA vaccine development under the contracts with domestic and international companies to expand its vaccine portfolio by securing next-generation vaccine platform. In May 2023, SK bioscience signed a manufacturing agreement with MSD for the next-generation Zaire Ebola vaccine candidate. In addition, the company is close to signing its first contract for the ‘Glocalization’ project, which transfers vaccine R&D and manufacturing capabilities to foreign countries with insufficient vaccine infrastructure