Valneva SE, a specialty vaccine company and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, today announced that the companies have entered into a strategic partnership and exclusive licensing agreement for the development, manufacturing and commercialization of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis.

Shigella_stool

Source: CDC

This photomicrograph reveals stool exudates in a patient with shigellosis, which is also known as “Shigella dysentery”, or “Bacterial dysentery”. Usually, those who are infected with Shigella develop diarrhea, which is often bloody, fever, and stomach cramps starting a day or two after they are exposed to the bacterium.

Shigellosis, caused by Shigella bacteria, is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year, particularly among children in Low- and Middle-Income Countries (LMICs).

No approved Shigella vaccine is currently available and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO).

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Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions. The global market for a vaccine against Shigella is estimated to exceed $500 million annually.

Terms of agreement

Under the terms of the agreement with Valneva, LimmaTech will receive an upfront payment of €10 million and be eligible to receive additional regulatory, development and sales-based milestone payments as well as low double-digit royalties on sales. LimmaTech will be responsible for conducting a Phase 2 Controlled Human Infection Model (CHIM) and a Phase 2 pediatric study in LMICs. Both clinical trials are expected to begin in the second half of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide if approved.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are very pleased to partner with LimmaTech to advance a promising program 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. The anticipated development path follows a staggered and risk-mitigated strategy, and hence allows an efficient capital allocation in line with our communicated plan of having a new R&D program in Phase 3 by 2027.”

Accelerating the program

Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, said, “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 program with our partnership with Valneva. Their proven expertise in late-stage development and commercialization of vaccines will expedite potential market approval and bring a Shigella vaccine to people in need. This agreement underscores our capabilities to leverage LimmaTech’s proficiency in vaccine development with the best path to develop programs rapidly. We continue to expand our pipeline of vaccine candidates to combat microbial-based infectious diseases, providing protection against antimicrobial resistance, a dramatically increasing global health threat.”

LimmaTech initiated the tetravalent Shigella vaccine candidate and continued to lead its development as part of its ongoing collaboration with GSK, and later in-licensed the vaccine candidate from GSK. In February 2024, LimmaTech reported positive interim Phase 1/2 data for the S4V vaccine candidate,  including 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 1/2 study confirmed the interim data.

About Shigellosis

Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths. The standard treatment for shigellosis is oral rehydration and antibiotic therapy - however, the 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.

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