Valneva and LimmaTech Collaborate on Shigellosis Vaccine

Valneva and LimmaTech Biologics have embarked on a strategic partnership to advance the Shigella4V (S4V) vaccine candidate, a tetravalent bioconjugate vaccine aimed at combating shigellosis. Under the terms of the agreement, Valneva will make an initial payment of €10 million to LimmaTech, with the latter eligible for additional payments based on regulatory milestones, development progress, and sales achievements. Furthermore, LimmaTech will receive low double-digit royalties on sales.

LimmaTech will lead the initial stages of the clinical development, which includes a Phase II clinical trial in lower and middle-income countries slated to begin in the second half of 2024. Following the completion of these trials, Valneva will assume responsibility for further development activities, including the chemistry, manufacturing, controls (CMC), regulatory interactions, and global commercialization plans for the S4V vaccine.

The development of the S4V vaccine initially began under a partnership between LimmaTech and GSK. LimmaTech subsequently acquired the rights from GSK in July 2023. This new partnership with Valneva aims to push the vaccine candidate further in development and add to Valneva's expanding vaccine portfolio. Last year, Valneva marked a significant milestone by securing the first worldwide approval for a chikungunya vaccine from the US Food and Drug Administration (FDA). Valneva’s current experimental pipeline also includes a Phase I Zika virus vaccine (VLA1601) and a Phase II Lyme disease vaccine (VLA15).

Despite significant public health concerns, there are currently no approved vaccines for shigellosis, which is caused by shigella bacteria and results in severe intestinal symptoms. The World Health Organization (WHO) has highlighted the urgency of developing a shigella vaccine, identifying it as a priority action due to its significant mortality rate, especially among children in lower-income regions. Shigella is reported to be the second leading cause of diarrhoeal deaths globally, responsible for approximately 212,000 deaths annually.

CEO of Valneva, Thomas Lingelbach, emphasized the potential impact of the Shigella vaccine candidate, describing it as a first-in-class solution for both lower and middle-income countries and travelers. He noted that the development approach is designed to be staggered and risk-mitigated, allowing efficient capital allocation with the goal of advancing a new research and development program to Phase III by 2027.

The strategic agreement between Valneva and LimmaTech underscores the importance of collaborative efforts in the biopharmaceutical industry to address unmet medical needs. With the backing of two experienced players in the vaccine development arena, the S4V vaccine holds promise as a significant advancement in the fight against shigellosis.

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