Sanofi announces agreement on a potential first-in-class vaccine against extraintestinal pathogenic strains of E. Coli
The strains
E.coli
causes of extraintestinal infections (or ExPEC) are one of the leading causes of sepsis and responsible for approximately 10 million cases of invasive infections per year worldwide
1.2
.A phase III clinical trial of the vaccine candidate is underway. This new vaccine against extra-intestinal pathogenic strains of
E.coli
is expected to complement Sanofi’s current portfolio of vaccines for older adults.
Paris, October 3, 2023
. Sanofi today announced that it has entered into an agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize a 9-valent vaccine candidate against extra-viral pathogenic strains. intestinal
E.coli
developed by Janssen. This vaccine candidate is currently the subject of a phase III clinical trial. This agreement combines Janssen’s strong scientific know-how behind this potentially first-in-class pharmacotherapeutic product, and Sanofi’s global industrial footprint and globally recognized expertise in launching innovative vaccines.
Thomas Triumph
Executive Vice President, Vaccines, Sanofi
“E. coli
is an important cause of sepsis, mortality and antibiotic resistance in older adults and the number of cases increases with the aging of the population. Our ambition is to design and offer drugs and vaccines that are the first or the best in their pharmacotherapeutic class. This agreement with Janssen aims to have a positive impact on public health by reducing hospitalization expenses and the burden that infections caused by extraintestinal pathogenic strains of
E.coli
strain on health systems, and enable older adults to live longer and healthier lives everywhere.
»
Under the terms of the agreement, both parties will co-finance current and future research and development expenses. Sanofi will make an upfront payment of US$175 million to Janssen, followed by milestone payments based on the achievement of certain development and commercial objectives. A profit sharing agreement will be put in place in the United States, in four countries of the European Union (Germany, Spain, France, Italy), as well as in the United Kingdom. Elsewhere in the world, Janssen will receive tiered royalties and milestone payments based on sales achieved. The fence is subject to customary regulatory approvals.
Extraintestinal pathogenic strains of
E.coli
are among the leading causes of sepsis, particularly in older adults
3
. Sepsis is caused by a bacterial infection that spreads through the bloodstream and causes acute disruption of the body’s response, resulting in loss of organ function and life-threatening risk to the patient. The main risk factors are age (people aged 60 and over) and the presence of a chronic disease (diabetes, cancer or kidney failure). The strains of
E.coli
Antibiotic-resistant strains have become one of the main concerns of medicine today and extraintestinal pathogenic strains of
E.coli
are among the bacteria that contribute most to the threat that antibiotic resistance poses to global health
4
.
The phase III trial
E.mbrace
ongoing is designed to evaluate the effectiveness of a nonavalent vaccine against extraintestinal pathogenic strains of
E.coli
(ExPEC9V), compared to a placebo, for the prevention of invasive infections due
E.coli
(ExPEC9V O serotypes). The study was launched by Janssen in 2021 and patient recruitment continues. For more information :
https://classic.clinicaltrials.gov/ct2/show/NCT04899336
1
Russo TA and Johnson JR. Medical and economic impact of extraintestinal infections due to Escherichia coli: focus on an increasingly important endemic problem. Microbes Infect. 2003;5:449–456.
2
Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020;395(10219):200-211. doi:10.1016/S0140-6736(19)32989-7
3
Rhee C, et al. Prevalence of Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated with Inadequate and Broad-Spectrum Empiric Antibiotic Use. JAMA Network Open. 2020;3(4): e202899.
4
O’Neill J. Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. Review on Antimicrobial Resistance. Available at: https://amr-review.org/sites/default/files/AMR%20Review%20Pa
per%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf. Last accessed: October 2022.
About Sanofi
We are an innovative, global health company driven by a purpose: pursuing the miracles of science to improve people’s lives. Our teams, present in around a hundred countries, are working to transform the practice of medicine to make the impossible possible. We provide therapeutic solutions that can change the lives of patients and vaccines that protect millions of people around the world, guided by the ambition of sustainable development and our social responsibility.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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