Sanofi and Janssen Sign Agreement for Phase III Extraintestinal Pathogenic E. coli Vaccine Candidate

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On Oct 3, 2023, Sanofi announced an agreement with Janssen Pharmaceuticals to develop and commercialize Janssen’s Phase III vaccine candidate for extraintestinal pathogenic Escherichia coli (E. coli) (9-valent). Both companies will co-fund current and future research and development costs, and there will be a profit-share agreement in the United States, the European Union, and the United Kingdom. Janssen will receive tiered royalties and sales milestones in the rest of the world. Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones. The Phase III trial, called E.mbrace, is intended to assess the efficacy 9-valent extraintestinal pathogenic E.coli vaccine (ExPEC9V0), as compared to placebo, in the prevention of invasive E.coli disease caused by ExPEC9V O-serotypes.

Extraintestinal pathogenic E. coli (ExPEC) is a main bacterial cause of sepsis, a chronic and life-threatening bloodstream infection, especially in older adults. Major risk factors for ExPEC include age (especially older than 60) and chronic illnesses, such as diabetes, kidney disease, or cancer. It causes around 10 million cases of invasive ExPEC disease annually worldwide and is a large force behind the global Antimicrobial Resistance crisis. Antimicrobial resistant E. coli strains are an ongoing concern in the global healthcare community.

In a Sanofi press release, Thomas Triomphe, executive vice president, Vaccines, Sanofi, said, “E. coli is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults, and the number of cases is rising as the population ages. In line with our commitment to design and deliver first- or best-in-class medicines and vaccines, this agreement with Janssen aims to positively impact public health by reducing hospitalization costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives.”

Source: Sanofi