Valneva and LimmaTech Biologics collaborate on Shigella vaccine development

16 August 2024

Valneva has entered into a strategic partnership and exclusive licensing agreement with LimmaTech Biologics to fast-track the development of a Shigella vaccine candidate. Shigella is the second leading cause of deadly diarrhoeal disease worldwide, particularly affecting children in low- and middle-income countries (LMICs). The World Health Organization has highlighted the urgent need for a Shigella vaccine due to its significant health burden.

Through this new agreement, Valneva gains an exclusive global licence to LimmaTech’s Shigella4V, a tetravalent bioconjugate vaccine. This vaccine has demonstrated promise in a phase 1/2 clinical trial, showing a good safety profile and significant immunogenicity against the four most common pathogenic Shigella serotypes. Earlier this year, interim data from this study showed the vaccine candidate's potential to meet unmet medical needs.

LimmaTech will now proceed with a phase 2 controlled human infection model and a phase 2 paediatric study in LMICs, set to begin later this year. Valneva will take on all further development, regulatory processes, and global commercialisation of the vaccine if it gains approval. In return, LimmaTech will receive an upfront payment of €10 million and will be eligible for additional payments based on regulatory, development, and sales milestones. They will also earn low double-digit royalties from future sales.

Thomas Lingelbach, Valneva’s CEO, expressed enthusiasm about the partnership, stating, "We are very pleased to partner with LimmaTech to advance a promising programme in an area of high unmet medical need. The Shigella vaccine candidate enables a potential first-in-class vaccine solution for both LMICs and travelers and, as such, represents a potentially highly synergistic product for Valneva."

LimmaTech originally initiated the development of Shigella4V and has continued its progress through an existing collaboration with GSK. Dr. Franz-Werner Haas, CEO of LimmaTech, commented on the new agreement with Valneva, saying, "Having developed the S4V Shigella vaccine candidate from its early discovery phase to the promising clinical data we achieved to date, we are excited to accelerate the programme with our partnership with Valneva. [Their] proven expertise in late-stage development and commercialisation of vaccines will expedite potential market approval and bring a Shigella vaccine to people in need."

The Shigella4V vaccine candidate represents a significant step forward in addressing a major global health challenge, especially in regions that are most affected by the disease. If successful, the partnership between Valneva and LimmaTech could lead to the first approved vaccine for Shigella, providing a crucial tool in combating diarrhoeal diseases and potentially saving countless lives.

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