SK Bioscience and Sanofi announced on December 11 that they have initiated the process to enter clinical trials with the submission of a U.S. (FDA) Phase 3 Investigational New Drug Application (IND) for their jointly developed 21-valent pneumococcal protein conjugate vaccine candidate GBP410 (Sanofi's project name 'SP0202') on December 8 local time.
The FDA Phase 3 IND application process is expected to be completed through additional submissions.
Previously, in August, SK Bioscience and Sanofi successfully completed a Phase 2 clinical trial of GBP410. The study, which compared GBP410 to a control vaccine (Prevenar®13) in 140 children aged 12-15 months and 712 infants aged 42-89 days, confirmed GBP410's equivalent immunogenicity to the control vaccine.
In terms of safety, no serious vaccine-related adverse events were reported in the GBP410 dose group, and GBP410 demonstrated equivalent immunogenicity and safety when coadministered with recommended infant and childhood vaccines, including tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b vaccines.
Based on these Phase 2 results, SK Bioscience and Sanofi aim to complete a Phase 3 clinical trial in infants and children in multiple countries, including the U.S., Europe and South Korea, by 2027.
GBP410 is a protein-conjugate vaccine candidate made by conjugating specific proteins to the pneumococcal coat polysaccharide that causes pneumonia, acute otitis media, and invasive disease, and the protein-conjugate method is known to be highly protective. In particular, GBP410 is expected to provide a wider range of protection as it contains 21 serotypes, more than the existing vaccines that currently dominate the global market.
"We are one step closer to successfully developing a pneumococcal protein conjugate vaccine, which only a few of the world's leading vaccine companies have succeeded in doing," said Ahn Jae-Yong, President of SK Bioscience. "With approximately 740,000 infants, children, and adolescents dying from pneumonia every year worldwide, we will contribute to global public health through the development of GBP410 and grow into a market-leading company."
Meanwhile, SK Bioscience has recently been expanding its global collaborations and taking steps toward overseas expansion. Based on its experience in developing COVID-19 vaccines, the company is collaborating with leading domestic and foreign companies to expand its next-generation vaccine platform, including mRNA.
The company has also signed a contract with global healthcare company MSD to produce a new vaccine candidate for the next-generation Zaire Ebola Virus vaccine, and has launched the 'Glocalization' project to quickly establish R&D and production bases in countries with inadequate vaccine infrastructure, such as Thailand and Serbia.
