Press releases
SK bioscience-Sanofi’s 21-Valent Pneumococcal Conjugate Vaccine Candidate for Phase 3 Studies IND Amendment Review Completed by U.S. FDA
2025.01.17
-U.S. FDA has reviewed the Investigational New Drug (IND) amendment for the Phase 3 clinical studies of GBP410.
-Both companies will evaluate the immunogenicity and safety of GBP410 in the phase 3 studies conducted in approximately 7,700 infants and adolescents aged 6 weeks to 17 years.
-Both companies also signed an expanded agreement to develop next-generation pneumococcal vaccines beyond GBP410, worth up to KRW 530 billion.
-“With innovative pneumococcal conjugate vaccines, we are committed to bringing safe and effective protection to more people throughout the world.”
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, is a step closer to entering the global pneumococcal market.
SK bioscience and Sanofi announced that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug (IND) amendment for the Phase 3 clinical study of GBP410, the 21-valent pneumococcal conjugate vaccine (PCV) candidate, jointly developed by SK bioscience and Sanofi. Earlier, the companies have received the IND approval from the Korean Ministry of Food and Drug Safety (MFDS).
Together with the recently announced the signing of an expanded agreement to co-develop next-generation PCVs, it is expected to be a new growth engine for the company and secure a leading position in a market worth trillion of won in annual sales.
The global phase 3 studies of GBP410 will evaluate the immunogenicity and safety of GBP410 in more than 7,700 healthy infants, toddlers, young children, and adolescents aged 6 weeks to 17 years after up to four doses, depending on the age at enrollment. The two companies have commenced the phase 3 program for GBP410, with the first participant dosed in December 2024 in Australia.
In June 2023, SK bioscience and Sanofi successfully completed a phase 2 study of GBP410, showing comparable immunogenicity compared to the control vaccine Prevnar 13, following the primary vaccination at 2, 4, and 6 months of age as well as the booster vaccination administered at 12-15 months. The study enrolled 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89 days.
In terms of safety, there were no vaccine-related serious adverse events. Furthermore, when co-administered with recommended childhood vaccines such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b (Hib) vaccine, GBP410 demonstrated comparable immunogenicity and safety to the control vaccine.
GPB410 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants and toddlers. With this broader coverage, GBP410 is expected to make a significant contribution to reducing cases of invasive pneumococcal disease (IPD), which remains a serious health concern in infants and young children.
According to the World Health Organization (WHO), approximately 300,000 children under the age of five worldwide die every year due to Streptococcus pneumoniae which is the leading cause of vaccine-preventable fatalities in this age group. This underscores the critical need for pneumococcal vaccines like GBP410.
SK bioscience is proactively preparing for the commercialization of GBP410, having initiated the expansion of its vaccine manufacturing plant ‘L House’ in March 2024 through a joint investment with Sanofi.
At the same time, SK bioscience and Sanofi have expanded their collaboration beyond the development and commercialization of GBP410, raising market expectations. The expanded agreement, signed last month, aims to co-develop next-generation pneumococcal conjugate vaccines (PCVs) for both pediatric and adult populations, with the potential to provide broader protection than those currently licensed.
Under the terms of the agreement to co-develop next-generation PCVs, Sanofi will pay SK bioscience an upfront payment of EUR 50 million (KRW 75.5 billion) followed by development and commercial milestone payments of up to EUR 300 million (KRW 450 billion).
The research and development costs for the vaccine will be shared equally by the two companies, while Sanofi will bear all costs related to commercialization. Once registered, SK bioscience will have commercial exclusivity in Korea, while Sanofi will commercialize the vaccines in all other markets. SK bioscience will receive royalty payments on product sales outside South Korea.
Pneumococcal conjugate vaccines are well known to provide the effective protection against pneumococcal infections among the pneumococcal vaccines developed to date. The PCVs dominated the market, accounting for 94 percent of global revenue, highlighting their critical role in preventing pneumococcal diseases.
According to Evaluate Pharma data (June 2024), the global pneumococcal conjugate vaccine market is projected to grow from KRW 11.9 trillion in 2024 to KRW 14.2 trillion in 2028, with an average annual growth rate (CAGR) of 4.7%. By targeting this rapidly expanding market, SK bioscience aims to secure new growth engines and solidify its position as a leading global vaccine and biotech company.
Jaeyong Ahn, CEO of SK bioscience, said, “The FDA’s review of the Investigational New Drug (IND) amendment for the Phase 3 clinical study of GBP410 is a significant step forward in the development of GBP410. With GBP410 and the next-generation PCVs in development, we are committed to addressing unmet public health needs and bringing safe and effective protection to more people throughout the world.”
