Sanofi and SK Bioscience Expand Pneumococcal Vaccine Partnership, Launch Phase 3 Trial for PCV21

Sanofi and SK bioscience announced an expansion of their agreement to jointly develop pneumococcal conjugate vaccines (PCVs) targeting both pediatric and adult populations.

The companies recently signed an expanded agreement that builds on their existing collaboration to develop and commercialize GBP410, a 21-valent pneumococcal conjugate vaccine candidate. As part of the joint venture, the companies will initiate a phase 3 trial for GBP410 following positive phase 2 results reported in 2023. The study is expected to include over 7700 infants, toddlers, young children, and adolescents across the US, Europe, Australia, Asia, and Latin America.

Under the new agreement, Sanofi will provide an upfront payment of approximately $51 million to SK bioscience, with additional milestones. Research and development expenses will be shared equally between the companies, whereas Sanofi will cover all commercialization expenses. SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales.

“Given the vast unmet public health needs in IPD, we’re delighted to extend this collaboration and continue our pursuit of innovative work in PCV,” Thomas Triomphe, executive vice president, vaccines, Sanofi, said in a press release. “Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and brining innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.”

In June 2024, the US FDA approved Merck’s 21-valent pneumococcal vaccine Capvaxive, the only pneumococcal vaccine formulated specifically to protect adults 50 years and older from IPD.

Reference: Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines. News release. Sanofi. December 23, 2024. Accessed January 6, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-23-06-00-00-3001006