A year and a half after Sanofi swooped in on Johnson & Johnson’s dismantled vaccines unit to pick up an E. coli candidate, the asset has failed its phase 3 trial.
A scheduled review by the study’s independent data monitoring committee (IDMC) had decided that the vaccine was “not sufficiently effective” at preventing invasive E. coli disease compared to placebo, Sanofi reported in a Feb. 13 release.
The phase 3 trial had aimed to enroll 18,500 people aged 60 years and up with a history of urinary tract infection to assess whether the nine-valent vaccine candidate could prevent invasive extraintestinal pathogenic E. coli disease, a leading bacterial cause of sepsis.
If successful, the vaccine could have tackled a top cause of death in seniors while cutting the burdens the pathogen imposes on healthcare systems and reducing the use of antibiotics, some of which are being rendered ineffective by the evolution of the bacterium.
However, as a result of the committee’s verdict, the study will be discontinued, Sanofi said this morning. No safety signals related to the vaccine had been identified, the company pointed out.
The pharma will amend its fourth-quarter financial results to reflect an impairment charge of $250 million as a result of the discontinuation. However, the company’s 2025 guidance remains unchanged, it said in the release.
“We are disappointed to see that the vaccine was not associated with sufficient efficacy to support the trial continuation, and we will work tirelessly to understand the factors behind the IDMC’s finding and to share further analysis once available,” Sanofi’s head of vaccine R&D Jean-François Toussaint said in this morning’s release.
“While disappointed by this outcome, we remain steadfast in our commitment to drive innovation in R&D by developing first and best-in-class vaccines in areas of high unmet need,” Toussaint added.
Sanofi gambled $175 million to take the vaccine off J&J’s hands in October 2023. At the time, J&J had been reassessing its entire vaccines unit, including dropping programs against respiratory syncytial virus and other pathogens as well as closing an R&D site. Despite the shake-up, J&J had been continuing with the phase 3 E. coli vaccine trial, which had a targeted primary completion date of May 2025.
The vaccine caught Sanofi’s attention. In return for the upfront fee and an agreement to co-fund R&D costs, the French drugmaker secured commercialization rights for the candidate, with profit splits planned for the U.S. and certain European countries.
At the time, Sanofi framed the deal as a way to put its worldwide manufacturing footprint and expertise in launching vaccines behind the candidate.