Valneva SE and LimmaTech Biologics AG have announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis. This designation aims to accelerate the development and review of S4V, addressing a significant global health threat, particularly in low- and middle-income countries (LMICs).
Addressing a Critical Unmet Need
Shigellosis, caused by Shigella bacteria, results in an estimated 165 million cases and 600,000 deaths each year, with children in LMICs being disproportionately affected. The disease also poses a risk to international travelers and deployed military personnel. Currently, there is no approved vaccine for Shigella, and the rise of multidrug-resistant strains complicates treatment, making prevention a critical priority.
Thomas Lingelbach, Chief Executive Officer of Valneva, stated, "Shigellosis is the second leading cause of fatal diarrheal disease worldwide... Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease."
Strategic Partnership and Development Plan
Valneva and LimmaTech entered a strategic partnership in August 2024, granting Valneva an exclusive worldwide license for S4V. Following positive Phase 1/2 results, LimmaTech will conduct a Phase 2 Controlled Human Infection Model (CHIM) study in the U.S. and a Phase 2 pediatric study in LMICs, both anticipated to commence before the end of 2024. Valneva will then assume responsibility for further development, including chemistry, manufacturing, and controls (CMC), regulatory activities, and commercialization.
The anticipated regulatory pathway for S4V involves leveraging CHIM studies to support initial approval in adults, followed by field efficacy studies to potentially expand the indication to children.
The Significance of Fast Track Designation
Fast Track designation is granted by the FDA to products that demonstrate the potential to treat serious conditions and address unmet medical needs. It facilitates closer collaboration with the FDA, potentially expediting the development and review process. This designation underscores the urgent need for a Shigella vaccine and the potential of S4V to address this global health challenge.
Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, stated, "We are highly encouraged by the FDA’s Fast Track designation, which reinforces our efforts and underscores the significant potential of the S4V Shigella vaccine candidate to address a serious global health threat."
