Monday, July 15, 2024

Press Release: Sanofi Unveils Accord for Prospective Vaccine Targeting Extraintestinal Pathogenic E. coli, Possibly the First of Its Kind

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Sanofi has announced a collaboration with Janssen Pharmaceuticals, a Johnson & Johnson company, to develop and market a potential groundbreaking vaccine targeting extraintestinal pathogenic E. coli (ExPEC). ExPEC is a major cause of sepsis, leading to approximately 10 million cases of invasive ExPEC disease (IED) globally each year. The vaccine candidate, currently in Phase 3 clinical trials, has the potential to revolutionize the prevention of this life-threatening bacterial infection.

Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, emphasized the growing significance of E. coli in older adults, causing sepsis, mortality, and antimicrobial resistance. The collaboration aims to address these pressing public health concerns by reducing hospitalization costs and the burden on healthcare systems while improving the well-being of older individuals worldwide.

The agreement entails shared funding for ongoing and future research and development expenses. Sanofi will make an initial payment of USD 175 million to Janssen, followed by additional payments tied to development and commercial milestones. In specific regions, such as the U.S., EU countries (France, Germany, Italy, Spain), and the UK, profit-sharing arrangements will be in place, while Janssen will receive royalties and sales milestones in the rest of the world (ROW). The closing of the agreement is subject to customary regulatory approvals.

ExPEC, known for causing sepsis, especially in older adults, is a significant public health concern. Sepsis is a life-threatening bloodstream infection associated with severe illness and organ damage, often triggered by the body’s aggressive response to infection. Key risk factors include age (particularly 60+ years) and chronic medical conditions like diabetes, cancer, or kidney disease. The rise of antimicrobial-resistant (AMR) E. coli strains, with ExPEC as a major contributor, adds to the global AMR crisis.

The Phase 3 E.mbrace trial, initiated by Janssen in 2021, aims to assess the efficacy of the 9-valent ExPEC vaccine (ExPEC9V) in preventing invasive E. coli disease caused by ExPEC9V O-serotypes. The trial continues to enroll patients as part of its research efforts.

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