Sanofi, SK bioscience to develop next-gen PCVs

Despite decades of public health vaccination programs, invasive pneumococcal disease (IPD) continues to inflict a substantial burden of disease, primarily due to Streptococcus pneumoniae serotypes that are not included in currently available conjugate vaccines. Next-generation PCVs have the potential to extend vaccine coverage of disease-causing serotypes. This expansion builds on the companies’ existing collaboration to develop and commercialize a PCV21 pediatric vaccine, for which the phase III clinical program commenced last week. This vaccine candidate is the first-ever PCV containing more than 20 serotypes to enter a phase III clinical study in infants and toddlers.

The PCV 21 phase III program is based on positive phase II results communicated last year and will include more than 7,700 infants, toddlers, young children and adolescents across multiple geographies, including the US, Europe, Australia, Asia, and Latin America.

Under the terms of their expanded agreement, both companies will co-fund research and development costs. Sanofi will pay EUR 50M upfront to SK bioscience, followed by development and commercial milestone payments. Once registered, Sanofi will commercialize the vaccines worldwide except for South Korea, where SK bioscience will have commercial exclusivity. SK bioscience will receive royalty payments on product sales outside South Korea.

Jaeyong Ahn, CEO of SK bioscience, said, “We are getting closer to successfully developing the pneumococcal protein conjugate vaccine,” adding, “We will contribute to global public health by successfully developing of GBP 410, as 740,000 infants, children, and adolescents are dying from pneumonia every year.”