SK bioscience said on Friday that it confirmed the excellent immunogenicity and safety of its 21-valent pneumococcal protein conjugate vaccine, GBP410, in phase 2 clinical trials in infants.

Based on this data, SK bioscience and Sanofi plan to initiate a phase 3 study in the first half of 2024, expecting to secure the final data in 2027.

SK bioscience President and CEO, Ahn Jae-yong (left) and Sanofi Head of Vaccines GBU Thomas Triomphe pose at the Sanofi Vaccines Investor Event in London, the U.K., on Thursday where both companies presented the phase 2 study  results of the 21-valent pneumococcal conjugate vaccine candidate. (Credit: SK bioscience)
SK bioscience President and CEO, Ahn Jae-yong (left) and Sanofi Head of Vaccines GBU Thomas Triomphe pose at the Sanofi Vaccines Investor Event in London, the U.K., on Thursday where both companies presented the phase 2 study  results of the 21-valent pneumococcal conjugate vaccine candidate. (Credit: SK bioscience)

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. 

Pneumococcal vaccines are the largest single vaccine in the global vaccine market and are expected to grow from 10 trillion won (approximately $7.5 billion) in 2022 to 12 trillion won in 2028, according to statistics from Evaluate Pharma. 

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, said a company official from SK bioscience.

The phase 2 study enrolled 140 toddlers between 12 months and 15 months and 712 infants between 42 days and 89 days old in the U.S., Canada, and Honduras and administered baseline doses at 2,4,6 months and booster doses at 12-15 months.

Accordingly, the data showed a well-tolerated safety profile, with comparable immunogenicity to the control vaccine with 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.

"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,” said Jean-Francois Toussaint, Global Head of Vaccines R&D at Sanofi. “We believe these results offer us a strong path to phase 3 and then to licensure."

"The successful clinical results of the pneumococcal conjugate vaccine signify that SK bioscience's technology and capability in vaccine development can deliver best-in-class vaccine candidates and we will continue to develop vaccines based on global partnerships," said Ahn Jae-yong, CEO of SK bioscience.

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