SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that SK bioscience and Sanofi have initiated the submission process of an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to conduct a global Phase III clinical study of a jointly developed 21-valent pneumococcal conjugate vaccine candidate, ‘GBP410’ (also known as SP0202). To complete the filing process there will be additional submissions.

In August, SK bioscience and Sanofi successfully completed a Phase II clinical study of GBP410 with positive results. 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 Prevnar 13.

The vaccine candidate was a well-tolerated with a favorable safety profile and a comparable reactogenicity profile to the control vaccine. There were 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 containing vaccine.

Based on the positive Phase II study results, SK bioscience and Sanofi aim to complete Phase III clinical program for toddlers and infants in several countries, including the U.S., European countries and Korea with a final read out in 2027.

GBP410 is a pneumococcal conjugate vaccine candidate that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumococcal diseases such as pneumonia, acute otitis media and invasive pneumococcal disease. The pneumococcal conjugate vaccines are well known to provide effective protection against pneumococcal infections. 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.

Jaeyong Ahn, CEO of SK bioscience, said, “We are getting closer to successfully developing the pneumococcal protein conjugate vaccine,” adding, “We will contribute to global public health by successfully developing of GBP410, as 740,000 infants, children, and adolescents are dying from pneumonia every year.”