Valneva and LimmaTech Partner to Accelerate Tetravalent Shigella Vaccine Development

Valneva SE, a specialty vaccine company, has entered into a strategic partnership with LimmaTech Biologics AG, a clinical-stage biotech firm specializing in vaccines for severe diseases. This collaboration includes an exclusive licensing agreement to develop, manufacture, and market Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate targeting shigellosis. This disease, caused by Shigella bacteria, is the second major cause of fatal diarrheal disease globally, with an estimated 165 million cases and 600,000 deaths annually, particularly among children in Low- and Middle-Income Countries (LMICs). Currently, no approved vaccine for Shigella exists, and the World Health Organization (WHO) has prioritized its development. Shigellosis also impacts international travelers and military personnel in regions where the disease is endemic. The global market for a Shigella vaccine is projected to exceed $500 million annually.

Under the terms of the agreement, LimmaTech will receive an upfront payment of €10 million and will be eligible for additional payments based on regulatory, development, and sales milestones, as well as low double-digit royalties on sales. LimmaTech will conduct a Phase 2 Controlled Human Infection Model (CHIM) and a Phase 2 pediatric study in LMICs, with both trials expected to commence in the second half of 2024. Valneva will handle all subsequent development, including chemistry, manufacturing, and controls (CMC) and regulatory activities, and will be responsible for global commercialization if the vaccine is approved.

Thomas Lingelbach, CEO of Valneva, expressed enthusiasm about the partnership, highlighting the potential of the Shigella vaccine to address a significant unmet medical need. He noted that the vaccine candidate represents a potential first-in-class solution for both LMICs and travelers. Lingelbach also emphasized the efficient capital allocation strategy that aligns with Valneva's plan to have a new R&D program in Phase 3 by 2027.

Dr. Franz-Werner Haas, CEO of LimmaTech, shared his excitement about accelerating the S4V Shigella vaccine candidate through the partnership with Valneva. He highlighted LimmaTech’s success in developing the vaccine from its early discovery phase to promising clinical data. Haas emphasized the importance of Valneva's expertise in late-stage development and commercialization to expedite market approval and bring the Shigella vaccine to those in need. He underscored LimmaTech's ongoing efforts to expand its pipeline of vaccine candidates to combat microbial infectious diseases and address the growing threat of antimicrobial resistance.

LimmaTech initiated the development of the tetravalent Shigella vaccine candidate and continued its progress as part of a collaboration with GSK, from whom it later in-licensed the vaccine. In February 2024, LimmaTech reported positive interim Phase 1/2 data for the S4V vaccine, demonstrating a favorable safety profile and robust immunogenicity against the four most common Shigella serotypes: S. flexneri 2a, 3a, 6, and S. sonnei. The completed Phase 1/2 study confirmed these interim results.

Shigellosis remains a global health threat caused by Gram-negative Shigella bacteria, with 62.3 million cases occurring in children under five years old. The disease leads to significant morbidity and mortality in numerous countries, as well as among travelers and military personnel in endemic regions. With an estimated 600,000 deaths each year, Shigella is the second leading cause of diarrheal mortality. Current treatment methods, including oral rehydration and antibiotic therapy, are becoming less effective due to increasing antibiotic resistance. Consequently, the development of a Shigella vaccine is critically needed.

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