$10.8 Million Funds Shigella Vaccine Candidate Development

A seldom-discussed diarrheal disease that affects millions of children and adults may soon have a preventive vaccine available. Furthermore, the World Health Organization has identified Shigella prevention as a priority.

LimmaTech Biologics AG today announced that it entered into a strategic partnership and exclusive licensing agreement with Valneva SE for the development, manufacturing, and commercialization of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against Shigellosis.

As of August 1, 2024, no approved Shigella vaccine is available.

However, the global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually.

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.

Moreover, Shigellosis affects international travelers and military personnel in endemic regions.

Under the terms of the agreement with Valneva, LimmaTech confirmed it will receive an upfront payment of €10 million ($10.8m) 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 and a Phase 2 pediatric study. Both clinical trials are expected to begin in the second half of 2024.

Dr. Franz-Werner Haas, LimmaTech's Chief Executive Officer, said in a press release, “Having developed the S4V Shigella vaccine candidate from its early discovery phase to the promising clinical data we have achieved to date, we are excited to accelerate the program with our partnership with Valneva."

"This agreement underscores our capabilities to leverage LimmaTech’s proficiency in vaccine development with the best path to develop programs rapidly."

LimmaTech initiated the tetravalent Shigella vaccine candidate and continued to lead its development as part of its ongoing collaboration with GSK. Later, it 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 and robust data on immunogenicity against the four most common pathogenic Shigella serotypes: S. flexneri 2a, 3a, 6, and S. sonnei4.

LimmaTech Biologics AG LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections.