Sanofi, Janssen ink pact to develop vaccine for extraintestinal pathogenic E. coli

Under the terms of the agreement, both parties will co-fund current and future research and development costs. Sanofi will pay USD 175M upfront to Janssen, followed by development and commercial milestones. There will be a profit-share arrangement in the U.S., EU4 (France, Germany, Italy, Spain), and the UK. In the rest of the world (ROW), Janssen will receive tiered royalties and sales milestones. Closing is subject to customary regulatory clearance.

Extraintestinal pathogenic E. coli is a leading cause of sepsis, particularly in older adults. Sepsis is a life-threatening bloodstream infection accompanied by severe illness and widespread organ damage, generated by the body’s self-destructive response to the infection. The main risk factors include​ age, especially 60​+, and chronic illnesses (e.g., diabetes, cancer, or kidney disease). Antimicrobial resistant (AMR) E. coli strains are an ongoing healthcare concern, with extraintestinal pathogenic E. coli a major driver behind the global AMR crisis.

The ongoing Phase 3 E.mbrace trial is designed to evaluate the efficacy of the 9-valent extraintestinal pathogenic E. coli vaccine (ExPEC9V) compared to placebo in the prevention of invasive E. coli disease (IED) caused by ExPEC9V O-serotypes. The study was started in 2021 by Janssen and continues to enroll patients.