Valneva, LimmaTech Start Phase 2 Pediatric Trial for S4V2 Vaccine

Valneva SE a specialty vaccine company, and LimmaTech Biologics AG , a biotechnology company developing vaccines for the prevention of life-threatening diseases, today announced the vaccination of the first participant in the Phase 2 pediatric safety and immunogenicity trial of Shigella4V2 (S4V2), the world’s leading tetravalent bioconjugate vaccine candidate against shigellosis.

Shigellosis is the second leading cause of fatal diarrheal disease worldwide and contributes significantly to pediatric morbidity and mortality. Up to 165 million infections worldwide are estimated to be due to shigellosis, including 62.3 million in children under five years of age . 1 The development of an effective vaccine to prevent this deadly disease is a public health imperative in many parts of the world.

In the Phase 2 S4V02 trial (ID: NCT06523231 ), the safety and immunogenicity of S4V2 will be evaluated in approximately 110 nine-month-old infants, with the goal of identifying the best dose for use in Phase 3. Sponsored and conducted by LimmaTech, S4V02 is a randomized, controlled, blinded trial conducted at a single clinical trial site in Kenya. Participants will receive one of two doses of S4V2 or a placebo. Safety will be assessed throughout the trial for approximately six months after the last vaccination. Results of the study, which is funded by the Gates Foundation, are expected in the second half of 2025.

Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva , said, ""Seeing so many infants and children die from shigellosis is simply unacceptable if it is preventable with a vaccine. That is why the World Health Organization (WHO) 2 has made the development of shigella vaccines a priority. In line with our mission to develop vaccines for infectious diseases with unmet medical needs, we are focused on finding a preventative solution for this deadly disease.""

Dr. Patricia Martin, Chief Operating Officer of LimmaTech, added, “We are proud to be leading the development of a vaccine against shigella , and the initiation of this trial marks an important milestone in our collaboration with Valneva to combat shigellosis. We are encouraged by the potential of S4V2 to provide a solution to a serious global health threat and have a significant impact on protecting the health of so many children around the world.”

In November 2024, Valneva and LimmaTech announced the vaccination of the first participant in the Phase 2b Controlled Infection in Human (CHIM) trial of the S4V2 vaccine candidate (ID: NCT06615375 ) in approximately 120 healthy participants, aged 18 to 50 years, who had never had Shigellosis 3 . This CHIM trial is part of the two companies' phasing and de-risking strategy for the development of S4V2, as it is expected to provide initial efficacy results before initiating additional CHIM and Phase 3 trials.

The U.S. Food and Drug Administration (FDA) has granted Fast Track status to S4V2 4 , recognizing its potential to target a serious disease and address an unmet medical need.

About Shigellosis
Shigellosis is a global public health threat caused by the gram-negative Shigella bacteria . An estimated 165 million infections 5 are due to Shigella , and 62.3 million are reported to affect children under five years of age. Infectious diarrhea is a leading cause of morbidity and mortality in many countries and also affects travelers and military personnel deployed to endemic regions. Approximately 600,000 deaths are attributed to Shigella each year, and it is the second leading cause of fatal diarrhea 6 . The standard treatment for shigellosis is oral rehydration therapy and antibiotics. However, the bacteria are now resistant to many antibiotics, and many outbreaks report drug-resistant strains, making treatment extremely difficult. There is currently no approved vaccine against shigellosis.

About Valneva SE
Valneva is a specialty vaccine company focused on the development, production, and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has a highly specialized and focused approach and utilizes its expertise in different immunization pathways to develop vaccines for diseases for which vaccines do not yet exist or for which existing solutions can be improved.
The Company has a strong R&D track record having advanced several vaccines from early stages of research to commercialization. Valneva currently commercializes three travel vaccines, including the world's first vaccine against chikungunya, as well as certain third-party vaccines.
Revenues from the Company's growing commercial activity contribute to the continued advancement of its vaccine portfolio. This includes the only Lyme disease vaccine candidate in late-stage clinical development, in partnership with Pfizer, the world's most advanced vaccine candidate against Shigellosis, as well as vaccine candidates against Zika virus and other global public health threats. More information is available at www.valneva.com .

About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global epidemic of antimicrobial resistance with its unparalleled track record in vaccine technology and clinical candidate development. The company leverages its proprietary platform of self-adjuvanted and multi-antigen vaccines, as well as other disease-specific vaccine approaches, to prevent increasingly difficult-to-treat microbial infections. With decades of expertise and a robust and expanding product pipeline, the LimmaTech team is dedicated to developing protective solutions to deliver value worldwide.
LimmaTech Biologics is backed by specialty healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.

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