Valneva and LimmaTech Biologics announced in October 2024 that they have been granted Fast Track designation by the United States FDA for Shigella4V (S4V). S4V is “the world’s most clinically advanced” tetravalent bioconjugate shigellosis vaccine candidate. In August 2024 the two organisations announced a strategic partnership and exclusive licensing agreement to develop, manufacture, and commercialise S4V. The FDA designation is granted to products in development that have the potential to treat serious conditions and fill an unmet medical need, with the goal of facilitating clinical development and expediting review.
Addressing a global health threat
An estimated 165 million cases of disease and 600,000 deaths are attributed to Shigella every year; the greatest burden is among children in low- and middle-income countries (LMICs). Shigellosis also affects international travellers from high-income countries and deployed military personnel in endemic regions.
Thomas Lingelbach, Chief Executive Officer of Valneva, stated that shigellosis is the “second leading cause of fatal diarrhoeal disease worldwide” with no approved Shigella vaccine.
“The development of Shigella vaccines has been identified as a priority by the World Health Organisation (WHO). Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease.”
Dr Franz-Werner Haas, Chief Executive Officer of LimmaTech, is “highly encouraged” by the designation, which “reinforces our efforts”.
“[It] underscores the significant potential of the S4V Shigella vaccine candidate to address a serious global health threat.”
The way forward
After positive Phase I/II results earlier in the year, LimmaTech will conduct a Phase II Controlled Human Infection Model study (CHIM) in the United States and a Phase II paediatric study in LMICs. These are expected to begin before the end of 2024. Valneva will assume all further development, including chemistry, manufacturing, and controls (CMC) and regulatory activities. It will also be responsible for global commercialisation if the vaccine is approved.
