First-in-Class Extraintestinal Pathogenic E. coli Vaccine Candidates Gains a Partner

Two world-class pharmaceutical companies announced an agreement for a potential first-in-class vaccine against extraintestinal pathogenic E. coli.

On October 3, 2023, France-based Sanofi confirmed it has agreed with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, to develop and commercialize a 9-valent vaccine candidate for extraintestinal pathogenic E. coli currently in Phase 3 study.

The agreement combines Janssen's robust science behind this potential first-in-class product, Sanofi's worldwide manufacturing footprint, and the recognized world-class expertise of these companies in launching innovative vaccines.

This is important news since Extraintestinal pathogenic E. coli is a leading cause of sepsis, particularly in older adults, with an approved vaccine available in 2023.

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.

Thomas Triomphe, Executive Vice President, Vaccines, at Sanofi, commented in a press release, "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."

The ongoing Phase 3 E.mbrace clinical trial is designed to evaluate the efficacy of the 9-valent extraintestinal pathogenic  E. coli vaccine (ExPEC9V) compared to placebo in preventing invasive E. coli disease caused by ExPEC9V O-serotypes.

The study was started in 2021 by Janssen and continues to enroll patients. To learn more, visit  https://classic.clinicaltrials.gov/ct2/show/NCT04899336. 

Under the terms of the new agreement, both companies will co-fund current and future research and development costs.

Sanofi will pay USD 175M upfront to Janssen, followed by development and commercial milestones. A profit-share arrangement will exist in the U.S., EU4 (France, Germany, Italy, Spain), and the U.K. In the rest of the world, Janssen will receive tiered royalties and sales milestones.