Pharma Focus Asia

SK Bioscience and Sanofi Receive IND Approval for Phase 3 Global Clinical Trial of Next-Generation Pneumococcal Vaccine

Tuesday, June 25, 2024

SK Bioscience and Sanofi have reached a significant milestone with the approval of the global Phase 3 clinical trial plan for their 21-valent pneumococcal conjugate vaccine candidate, GBP410 (known as SP0202 by Sanofi). This approval, granted by the Australian Human Research Ethics Committee, marks the first step towards conducting Phase 3 trials worldwide. Additional approvals are anticipated in the United States, Europe, Korea, and Honduras.

The Phase 3 trials will involve approximately 8,000 participants aged 6 weeks to 17 years, evaluating the immunogenicity and safety of GBP410 after up to four doses. These trials are scheduled to start in Australia in the fourth quarter of this year, with plans to complete them by 2027 and subsequently seek regulatory approval from the FDA and EMA.

GBP410 is distinguished by its conjugation of a specific protein to pneumococcal capsular polysaccharide, enhancing its efficacy against pneumonia and other invasive diseases. With 21 serotypes, it offers broader protection compared to existing pediatric vaccines, potentially increasing prevention against invasive pneumococcal disease by 5-7%.

Following successful Phase 2 trials, which demonstrated comparable immunogenicity to the control vaccine Prevenar 13 and confirmed safety even when administered alongside other recommended vaccines, SK Bioscience and Sanofi are optimistic about the vaccine's commercial prospects. To support its production, SK Bioscience is expanding its vaccine facility 'L House' and securing cGMP certification, ensuring global manufacturing standards are met.

SK Bioscience's President Ahn Jae-yong expressed confidence in the Phase 3 trials and highlighted their partnership with Sanofi to introduce this vaccine globally, positioning SK Bioscience as a key player in the competitive pneumococcal vaccine market.

 

Source: skbioscience.com

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