Sanofi partners J&J on E. coli vaccine

Sanofi is paying $175 million upfront to claim a share of an experimental vaccine developed by Johnson & Johnson’s pharma unit Janssen that aims to tackle a major cause of blood infections.

The vaccine, currently in phase 3 trials, targets extraintestinal pathogenic Escherichia coli or ‘ExPEC’, which is estimated to cause around 10 million cases of invasive disease every year and is a leading cause of bacterial sepsis, accounting for around 40% of all cases, according to some studies.

The search for a vaccine has become particularly important as antimicrobial resistance (AMR) is on the rise in ExPEC, with standard cephalosporin-based treatment losing its efficacy, raising the risk that patients progress to sepsis, septic shock, and organ failure.

The nine-valent ExPEC9V bioconjugate vaccine, targeting nine separate strains of E. coli and also known as VAC52416, is currently being compared to placebo in a phase 3 trial involving around 18,500 patients aged 60 years and over, the age group most at risk of invasive E. coli disease (IED).

All the patients in the study are considered at risk of IED because they have a history of urinary tract infections, and will be followed up for three years. The trial started in 2021 and is due to generate results in 2025, according to its clinicaltrials.gov listing.

A recent US study looking at IED showed that more than three-quarters of patients presenting in hospital with IED were aged over 60, with the urinary tract being the source of infection in around half of them, and with this age group most likely to show signs of organ failure.

Alarmingly, resistance to one standard antibiotic was seen in 66% of cases, with almost 41% also resistant to a drug from second antimicrobial class as well.

“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,” said Sanofi’s head of vaccines, Thomas Triomphe (pictured top).

“This agreement with Janssen aims to positively impact public health by reducing hospitalisation costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives,” he added.

The Centers for Disease Control and Prevention (CDC) has estimated the cost of treating sepsis at more than $20 billion a year, making it the most expensive reason for hospitalisation in the US.

Under the terms of the agreement, Sanofi and Janssen will co-fund R&D into the vaccine and share profits in the US, the UK, and four EU markets (France, Germany, Italy, and Spain). In the rest of the world, Sanofi will have sole commercial rights and pay royalties and sales milestones to Janssen.

Sanofi has made vaccines a key component of its growth strategy in the coming years, aiming to more than double sales in the category to €10 billion or more by 2030.