SK bioscience and Sanofi Successfully Complete Phase 2 Clinical Trial of Pneumococcal Vaccine
Key Highlights :
SK bioscience, a local vaccine developer and producer, and French biopharmaceutical company Sanofi announced the successful completion of the Phase 2 clinical trial of a 21-valent pneumococcal vaccine they are jointly developing. The two companies conducted comparative trials of the vaccine, known as GBP410, and a control vaccine in 140 children aged 12-15 months and 712 infants aged 42-89 days in the United States, Canada and Honduras, and confirmed equivalent levels of immunogenicity compared to the control vaccine.
Pneumococcal diseases are caused by bacteria known as Streptococcus pneumoniae, and can cause pneumonia, meningitis, and other serious infections. Vaccines are the most effective way to prevent these infections, and the pneumococcal vaccine is the largest single vaccine in the global vaccine market. It is expected to grow to 12 trillion won ($9.1 billion) in 2028 from 10 trillion in 2022, according to global pharmaceutical statistics organization Evaluate Pharma.
The GBP410 vaccine is a protein-conjugate vaccine that conjugates specific proteins to the pneumococcal coat polysaccharide that causes pneumonia and invasive disease. This protein conjugate method is said to be the most effective pneumococcal vaccine ever developed. In terms of safety, no serious vaccine-related adverse events were reported in the GBP410 dose group.
Following the successful completion of the Phase 2 clinical trial, SK bioscience is on track to enter the Phase 3 trial. Upon commercialization of GBP410, SK bioscience plans to increase its market share in cooperation with Sanofi, a pediatric vaccine market leader.
In addition to the development of the pneumococcal vaccine, SK bioscience is working to expand its vaccine lineup through cooperation with global partners. Recently, the company secured core technologies for mRNA vaccine development through agreements with leading domestic and overseas companies. In May, the company signed a contract with MSD to produce a new candidate for the next-generation Zaire Ebola vaccine candidate and is also working on establishing overseas R&D and vaccine production bases in countries with inadequate vaccine infrastructure.
The successful Phase 2 clinical trials of the pneumococcal conjugate vaccine signify that SK bioscience's technology and capability in vaccine development can deliver best-in-class vaccine candidates. With the continued commitment to developing and manufacturing vaccines based on the global partnership with major pharmaceutical companies, SK bioscience and Sanofi are on track to make a major impact on the global vaccine market.