SK Bioscience and Sanofi Advance Global Phase III Study for Pneumococcal Conjugate Vaccine

SK Bioscience, in collaboration with Sanofi, has commenced the submission process for an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA). This marks the initiation of a global Phase III clinical study for their jointly developed 21-valent pneumococcal conjugate vaccine candidate, known as GBP410 (Sanofi’s project name ‘SP0202’). Following positive Phase II results, the companies are taking a significant step forward in advancing the vaccine’s development.

Related article: Pfizer Racks Up Infant Indication for Pneumococcal Vaccine

Unveiling the Immunogenicity of GBP410 in Toddlers and Infants

In June, SK Bioscience and Sanofi successfully concluded a Phase II clinical study involving 140 toddlers and 712 infants. The study demonstrated the comparable immunogenicity of GBP410 to Prevnar 13, a widely used pneumococcal conjugate vaccine. Notably, GBP410 exhibited a well-tolerated and favorable safety profile, with no vaccine-related serious adverse events reported. Importantly, the vaccine did not impact the safety or immunogenicity of co-administered pediatric vaccines.

GBP410, the focus of this collaborative effort, is a pneumococcal conjugate vaccine candidate that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae. This bacterium is responsible for causing pneumococcal diseases, including pneumonia, acute otitis media, and invasive pneumococcal disease. With a total of 21 serotypes, GBP410 is designed to offer broader coverage compared to existing pneumococcal conjugate vaccines available in the global market.

Future Plans and Impact on Public Health

Building upon the positive outcomes of the Phase II study, SK Bioscience and Sanofi aim to complete the Phase III clinical program. This program will involve toddlers and infants in various countries, including the U.S., European nations, and Korea. The final readout is anticipated in 2027. Jaeyong Ahn, CEO of SK Bioscience, expressed optimism about the progress, stating their commitment to contributing to global public health by successfully developing GBP410.

Author

Sinead Huang