Sanofi-Janssen collaboration to advance novel E. coli vaccine

Sanofi and Janssen Pharmaceuticals have agreed to jointly develop and commercialise ExPEC9V, a 9-valent vaccine candidate for extraintestinal pathogenic E. coli (ExPEC).

Developed by Janssen, the potential first-in-class vaccine is currently in Phase III trials. It is administered as a single intramuscular (IM) injected dose. In total, there are 18,556 participants in the study.

Extraintestinal pathogenic E. coli is a leading cause of sepsis, mainly in older adults, 2020 research published in JAMA states. Extraintestinal pathogenic E. coli a major driver behind the global AMR crisis, according to a review on AMR by O’Neill.

Developing a potential first-in-class E. coli vaccine

Under the deal between the two pharma companies, Janssen and Sanofi will co-fund current and future research and development costs of the novel product candidate. Sanofi will pay $175M upfront to Janssen, followed by development and commercial milestones. There will be a profit-share arrangement in the US, France, Germany, Italy, Spain and the UK. In the rest of the world, Janssen will obtain tiered royalties and sales milestones.

The ongoing Phase III 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.

This new agreement “aims to positively impact public health by reducing hospitalisation costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives,” remarked Thomas Triomphe, Executive Vice President of Vaccines at Sanofi.

Closing of the agreement between Sanofi and Janssen is subject to requirements such as customary regulatory clearance.

Innovating in pharma

For Janssen, news of this collaboration follows last month’s announcement by Johnson & Johnson (J&J) that its pharmaceutical division was refreshing its identity and would be known going forward, as J&J Innovative Medicine.