Sanofi has entered into a significant partnership with Johnson & Johnson's Janssen unit, committing $175 million upfront to co-develop a promising vaccine targeting extraintestinal pathogenic Escherichia coli (ExPEC), a major cause of life-threatening blood infections.
The collaboration focuses on VAC52416 (ExPEC9V), a nine-valent bioconjugate vaccine currently undergoing phase 3 clinical evaluation. This innovative vaccine targets nine distinct E. coli strains responsible for severe invasive infections and represents a potential breakthrough in combating antimicrobial resistance.
Rising Threat of ExPEC Infections
ExPEC infections pose a substantial global health burden, causing approximately 10 million cases of invasive disease annually. The bacteria are responsible for roughly 40% of all bacterial sepsis cases, with treatment challenges intensifying due to growing antimicrobial resistance.
Recent studies have revealed alarming resistance patterns, with 66% of cases showing resistance to standard antibiotics and 41% demonstrating multi-drug resistance. This increasing antimicrobial resistance has made traditional cephalosporin-based treatments increasingly ineffective, elevating the risk of progression to sepsis and organ failure.
Phase 3 Trial Details
The ongoing phase 3 clinical trial is evaluating the vaccine's efficacy in a vulnerable population of 18,500 participants aged 60 years and older. All enrolled subjects have a history of urinary tract infections, placing them at higher risk for invasive E. coli disease. The study, which commenced in 2021, will track participants for three years, with results anticipated in 2025.
Economic and Healthcare Impact
"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," stated Thomas Triomphe, Sanofi's head of vaccines. The economic burden is substantial, with the CDC estimating annual sepsis treatment costs exceeding $20 billion in the US alone.
Partnership Structure
Under the collaboration agreement, both companies will share research and development costs and profits in key markets, including the United States, United Kingdom, and four major European Union countries (France, Germany, Italy, and Spain). Sanofi will retain exclusive commercial rights in other global markets, paying royalties and milestone payments to Janssen.
The partnership aims to address a critical public health challenge by reducing hospitalization costs and healthcare system burden while improving outcomes for vulnerable older adults worldwide.
