Sanofi and SK bioscience have commenced global Phase III clinical trials for their 21-valent pneumococcal conjugate vaccine candidate, GBP410 (also known as SP-0202). This vaccine is designed to protect against 21 serotypes of Streptococcus pneumoniae, the bacteria responsible for invasive pneumococcal disease (IPD). The trials aim to evaluate the safety and immunogenicity of GBP410 in a broad age range, from infants as young as six weeks to adolescents up to 17 years old.
Trial Design and Objectives
The Phase III program will enroll over 7,700 participants across multiple geographies, including the United States, Europe, Australia, Asia, and Latin America. Participants will receive up to four doses of the vaccine, with the specific dosing schedule varying based on their age at enrollment. The primary objectives of the study are to assess the safety profile of GBP410 and to determine its ability to elicit an immune response comparable to existing pneumococcal vaccines, such as Prevnar 13.
Jaeyong Ahn, CEO of SK bioscience, emphasized the significance of this milestone, stating, "The FDA’s review of the investigational new drug (IND) amendment for the Phase III 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."
Addressing Unmet Needs in IPD Prevention
Invasive pneumococcal disease remains a major global health challenge, particularly among young children. Despite the availability of current pneumococcal conjugate vaccines, a substantial burden of disease persists due to Streptococcus pneumoniae serotypes not included in these vaccines. GBP410, with its broader coverage, aims to address this gap and further reduce the incidence of IPD.
Collaboration and Future Development
Sanofi and SK bioscience have a long-standing collaboration in the development of pneumococcal vaccines. In conjunction with the Phase III trial initiation, the companies have expanded their agreement to develop, license, and commercialize next-generation PCVs for both pediatric and adult populations. Under the expanded agreement, Sanofi will make an upfront payment of €50 million to SK bioscience, with potential development and commercial milestone payments to follow. Sanofi will commercialize the vaccines worldwide, except for South Korea, where SK bioscience will retain commercial exclusivity.
Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, noted, “Given the vast unmet public health needs in IPD, we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.”
Phase II Data and Commercialization Plans
The Phase III program is supported by positive Phase II results, which demonstrated that GBP410 achieved comparable immunogenicity to Prevnar 13 after primary and booster vaccinations. The Phase II study, which included 140 toddlers and 712 infants, also showed that GBP410 maintained comparable immunogenicity and safety when co-administered with other recommended childhood vaccines. SK bioscience is expanding its manufacturing plant, 'L House,' in partnership with Sanofi, to support the commercialization of GBP410.
