Valneva licences LimmaTech’s Shigella vaccine

Under the terms of the global licence agreement with French-Austrian Valneva SE, Swiss LimmaTech Biologics AG will receive €10m upfront plus several milestone payments plus  low two-digit royalty payments on sales of S4V. LimmaTech will be responsible for conducting two Phase II studies: one in an Controlled Human Infection Model (CHIM) as well as a paediatric study in LMICs. Both clinical trials are expected to begin in the second half of 2024. Valneva will assume all further development, including CMC and regulatory activities, and be responsible for its commercialization worldwide in case of approval.

Shigella4V (S4V) is a tetravalent bioconjugate vaccine candidate against shigellosis. Shigellosis, caused by Shigella bacteria, is the second leading cause of fatal diarrheal disease worldwide. According to estimates, up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella every year, particularly among children in Low- and Middle-Income Countries.  The global market for a vaccine against Shigella is estimated to exceed US$500m per year.

LimmaTech, a specialist in vaccines against multidrug resistant pathogens, initiated the tetravalent Shigella vaccine candidate and continued to lead its development as part of its ongoing collaboration with GlaxoSmithKline, and later re-licensed the vaccine candidate from GSK. In February 2024, LimmaTech reported  a favorable safety and tolerability profile as well as robust data on immunogenicity against the four most common pathogenic Shigella serotypes, S. flexneri 2a, 3a, 6, and S. sonnei. The results of the completed Phase I/II study confirmed these interim data.

The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the Gram-negative bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available on the market.

Valneva recently got market approval for its Chikungunya vaccine, and has completed Phase III testing of its Lyme vaccine with commercialisation partner Pfizer Inc.