Sanofi and Janssen Pharmaceuticals, Inc. have announced a collaboration to develop and commercialize a groundbreaking vaccine targeting extraintestinal pathogenic Escherichia coli (ExPEC), a leading cause of sepsis. The vaccine, known as ExPEC9V, is currently in Phase 3 clinical trials and aims to combat the devastating impact of ExPEC on global health, particularly among older adults.
ExPEC is a significant public health concern, causing approximately 10 million cases of invasive ExPEC disease (IED) annually. Older adults and individuals with chronic illnesses are particularly at risk. The rise of antimicrobial-resistant strains of E. coli, with ExPEC playing a pivotal role, has further compounded the global healthcare crisis.
The 9-valent ExPEC vaccine represents a potential game-changer in the fight against ExPEC-related illnesses. Developed by Janssen Pharmaceuticals, it is currently undergoing Phase 3 clinical trials as part of the E.mbrace study. The study aims to evaluate the vaccine’s efficacy in preventing invasive E. coli disease caused by specific O-serotypes targeted by ExPEC9V.
The partnership between Sanofi and Janssen combines Janssen’s cutting-edge science behind ExPEC9V with Sanofi’s global manufacturing capabilities and expertise in vaccine development. Both companies will co-fund ongoing and future research and development costs, with Sanofi making an upfront payment of USD 175 million to Janssen. The agreement also includes profit-sharing arrangements and royalties to ensure the potential vaccine reaches those who need it most.
ExPEC9V takes a comprehensive approach to combat ExPEC, a bacterial pathogen with far-reaching implications for global health. Unlike intestinal pathogenic E. coli (IPEC), which are obligate pathogens, ExPEC is a facultative pathogen that can reside in the gut flora without causing harm. This makes the development of an effective vaccine against ExPEC complex but vital.
The ongoing Phase 3 E.mbrace trial is rigorously assessing the efficacy of ExPEC9V in preventing invasive E. coli disease in adults aged 60 and older. The study, initiated in 2021, incorporates multiple phases and safety assessments to ensure the vaccine’s safety and efficacy. The results of this trial hold the promise of a safer and healthier future for individuals worldwide.
In conclusion, the partnership between Sanofi and Janssen to develop and commercialize the potential first-in-class ExPEC vaccine is a significant milestone in the fight against sepsis and antimicrobial resistance. The ongoing Phase 3 trials offer hope in reducing hospitalization costs, alleviating the burden on healthcare systems, and extending the lives of individuals affected by ExPEC.