Valneva SE
For the period ended Dec 31, 2025. Filed Nov 26, 2025.
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Dec 31, 2025 · Filed Nov 26, 2025
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EX-99.1 · Two Phase 2 trials ongoing
Two Phase 2 trials ongoing
S4V2 is the world’s most clinically advanced tetravalent vaccine candidate against shigellosis, the second leading cause of fatal diarrhea worldwide. Two clinical studies of S4V2, a Phase 2 infant safety and immunogenicity study 7, and a Phase 2b Human Challenge Study (CHIM)8, sponsored by LimmaTech Biologics AG, are ongoing. Subject to positive results for both studies, Valneva will assume responsibility for all further development 9.
No approved multivalent Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)10. In October 2024, the U.S. FDA granted Fast Track designation to S4V2,
6 https://valneva.com/press-release/valneva-reports-95-seroresponse-four-years-after-single-shot-of-chikungunya-vaccine-ixchiq/
7 Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2 - Valneva
8 Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2
9 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva
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