21-Valent Pneumococcal Conjugate Vaccine Candidate Produced Positive Study Results

SK bioscience today announced positive results from its Phase II clinical trials in infants of its 21-valent pneumococcal conjugate vaccine candidate, 'GBP410' (SP0202), evaluating its safety and immunogenicity.

Given that GBP410 includes 21 serotypes, it is anticipated to offer broader serotype coverage than the existing pneumococcal conjugate vaccines.

The Phase II study 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.

The data also showed a well-tolerated safety profile, with a similar 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 its development partner 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.

Jean-Francois Toussaint, Global Head of Vaccines R&D at Sanofi, said in a press release on June 29, 2023, "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."