Without providing specific data, Sanofi on Thursday announced that the experimental vaccine did not significantly prevent invasive E. coli disease versus placebo.
Sanofi and Johnson & Johnson on Thursday terminated the Phase III E.mbrace study of their investigational vaccine for invasive E. coli disease due to disappointing data.
As a result of the termination, Sanofi will record a $250 million impairment charge, to be reflected in its fourth-quarter 2024 balance sheet, according to the company’s press announcement.
The decision to discontinue E.mbrace came after an independent data monitoring committee found during a scheduled review of the trial that the vaccine candidate “was not sufficiently effective at preventing” the disease versus placebo. Safety was clean overall, with no signals of concern linked to the shot throughout the study.
Patients who developed invasive E. coli disease (IED) were given adequate treatment, according to Thursday’s announcement.
Jean-François Toussaint, global head of vaccines R&D at Sanofi, said in a statement that the vaccine candidate “was not associated with sufficient efficacy to support the trial continuation” and that the pharma was “disappointed” by these findings. Sanofi will “work tirelessly” to understand the reasons behind the failure, which it plans to share with the broader medical community “once available,” Toussaint added.
Sanofi and J&J, through the latter’s subsidiary Janssen Pharmaceuticals, inked their vaccine pact in October 2023, with Sanofi surrendering $175 million upfront—though according to Thursday’s announcement, the pharma has already made $250 million in total payments under this deal, including certain milestones.
The partners set their sights on IED, which occurs when bacteria that typically stay in the intestines infiltrate and infect other parts of the body. Patients with IED suffer from a wide variety of infections, some of which can become severe and life-threatening, especially for seniors. To combat IED and its related complications, Sanofi and J&J agreed to co-fund R&D activities related to the vaccine candidate.
Following Thursday’s discontinuation, Janssen, the study sponsor, will be responsible for continuing the appropriate safety follow-up for enrolled participants.
Sanofi’s E. coli stumble comes just days after another big-ticket partnership suffered some strain. Last week, Dupixent partner Regeneron sued Sanofi, alleging that it failed to provide “full access to material information” regarding sales of the blockbuster drug, and that Sanofi, when asked to hand over relevant figures, “stonewalled” Regeneron.
For J&J, the discontinuation follows its massive $14.6 billion acquisition of neuro specialist Intra-Cellular last month. In the pharma’s fourth-quarter and full-year business report a week later, CEO Joaquin Duato told investors on a call that the pharma will be focusing on “smaller opportunities” for the rest of the year.
