Results from a Phase II study completed in June 2023 showed that the vaccine had comparable immunogenicity. Credit: New Africa/Shutterstock.

SK bioscience and Sanofi have announced plans for global Phase III studies, which will assess the safety and immunogenicity of their 21-valent pneumococcal conjugate vaccine candidate, GBP410, in more than 7,700 subjects aged six weeks to 17 years old.

The study will involve up to four doses, varying by age at enrolment.

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The companies’ latest announcement comes after the investigational new drug (IND) amendment of the study was reviewed by the US Food and Drug Administration (FDA).

SK bioscience CEO Jaeyong Ahn said: “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.”

The Korean Ministry of Food and Drug Safety (MFDS) granted IND approval for GBP410, which is jointly developed by both companies. The Phase III programme began last month, with the first subject dosed in Australia.

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Results from a Phase II study completed in June 2023 showed that the vaccine had comparable immunogenicity to Prevnar 13, the control vaccine, after primary and booster vaccinations.

The study included 140 toddlers and 712 infants and demonstrated that, when co-administered with other recommended childhood vaccines, GBP410 maintained comparable immunogenicity and safety.

With its broader coverage, GBP410 is expected to significantly minimise cases of invasive pneumococcal disease (IPD), a major health concern in young children.

SK bioscience is advancing the commercialisation of the vaccine with the expansion of its manufacturing plant ‘L House’, in partnership with Sanofi.

In addition to GBP410, the companies have signed an agreement to jointly develop next-generation pneumococcal vaccines for both paediatric and adult populations.

SK bioscience will receive an upfront payment of €50m ($51.4m) from Sanofi, along with development and commercial milestone payments that could total up to €300m ($308.7m).

Last month, SK bioscience received approval from Australia’s Human Research Ethics Committee (HREC) to begin Phase I/II trials of GBP560, an mRNA-based Japanese encephalitis vaccine candidate.