Sanofi starts Phase 3 for PCV21, expands SK bioscience partnership

Sanofi and SK bioscience have made significant strides in their collaborative efforts to tackle pneumococcal disease, a persistent global health issue, by expanding their partnership to develop new pneumococcal conjugate vaccines (PCVs). This joint initiative highlights their ongoing commitment to advancing healthcare solutions and aims to address the limitations of current vaccination programs.

Despite the availability of vaccines, pneumococcal disease continues to pose a serious threat to public health worldwide. This is primarily due to the invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae serotypes not covered by existing vaccines. The development of next-generation PCVs is seen as a crucial step in broadening the protection against these disease-causing serotypes.

At the forefront of this collaboration is the development of a 21-valent pneumococcal conjugate vaccine (PCV21), marking a groundbreaking advancement in vaccine research. The PCV21 is the first candidate of its kind, designed to target over 20 serotypes, to reach phase 3 clinical trials in infants and toddlers. This phase 3 program, which commenced recently, builds upon successful phase 2 results and involves over 7,700 participants across various regions, including the United States, Europe, Australia, Asia, and Latin America.

Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, expressed enthusiasm about expanding the collaboration with SK bioscience. He emphasized the importance of leveraging both companies' strengths to develop innovative vaccines that could significantly reduce the global impact of pneumococcal disease. This partnership not only aims to meet the unmet public health needs but also intends to set a benchmark in vaccine innovation.

Jaeyong Ahn, CEO and President of SK bioscience, echoed this sentiment. He highlighted the strategic importance of their partnership with Sanofi in developing new solutions against pneumococcal disease. Ahn also pointed out that the expansion of their advanced manufacturing facilities, co-financed by Sanofi, will be instrumental in launching PCV21 and future vaccines.

Under the terms of the expanded agreement, Sanofi has committed to an upfront payment of EUR 50 million to SK bioscience, alongside additional payments based on development and commercial milestones. Once the vaccine is approved and registered, Sanofi will handle its commercialization globally, except in South Korea, where SK bioscience will retain exclusive rights. Additionally, SK bioscience will earn royalties from the vaccine sales outside of South Korea.

This collaboration between Sanofi and SK bioscience represents a significant step toward addressing the global burden of pneumococcal disease. By advancing the development of next-generation vaccines, both companies are poised to make a substantial impact on public health, potentially saving millions of lives worldwide.