SK Bioscience and Sanofi have started the process of submitting a phase 3 Investigational New Drug (IND) to the U.S. FDA for their jointly developed 21-valent pneumococcal protein conjugate vaccine candidate, GBP410 (Sanofi's project name: SP0202), to proceed to clinical trials, the Korean vaccinemaker said on Monday. 

Previously, in August, SK bioscience and Sanofi completed a GBP410 phase 2 clinical trial. 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, demonstrating equivalent immunogenicity and safety when co-administered with recommended infant and childhood vaccines, comprising tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b vaccines.

Based on these phase 2 results, SK bioscience and Sanofi plan to complete a phase 3 clinical trial in infants and children in multiple countries, including the U.S., Europe, and Korea, by 2027.

GBP410 is a pneumococcal conjugate vaccine candidate that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumococcal diseases such as pneumonia, acute otitis media, and invasive pneumococcal disease.

Pneumococcus is the causative agent of pneumonia, as well as acute otitis media and meningitis. Person-to-person transmission through respiratory droplets poses a particular risk to the elderly and infants, potentially leading to fatal consequences. Pneumococcus was the fourth leading cause of death in Korea as of 2022.

SK bioscience stated that GBP410 is anticipated to encompass 21 serotypes, surpassing the coverage of the prevailing vaccine currently holding a dominant position in the global market.

“We are getting closer to successfully developing the pneumococcal protein conjugate vaccine,” said Ahn Jae-yong, CEO of SK bioscience. “We will contribute to global public health by successfully developing GBP410, as 740,000 infants, children, and adolescents are dying from pneumonia every year.”

To produce pneumococcal vaccines, SK bioscience plans to expand its vaccine production facility, L-House, in Andong, North Gyeongsang Province, by approximately 4,200 square meters.

Sanofi, a co-developer of the vaccine, will also invest in expanding L-House, which will be equipped with c-GMP, the U.S. standard for good manufacturing practice.