FDA Fast Tracks Valneva and LimmaTech's Tetravalent Shigella Vaccine S4V

Valneva SE, a vaccine company specializing in infectious diseases, and LimmaTech Biologics AG, a biotech company focused on vaccine development, have announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V). This designation is given to products in development that show potential in treating serious conditions with unmet medical needs, expediting the review process to ensure timely access for those in need.

Shigellosis, caused by the Shigella bacteria, is a significant global health concern and the second leading cause of deadly diarrheal disease. Despite the severity and prevalence of the disease, no Shigella vaccine has been approved so far. The World Health Organization (WHO) has identified the development of Shigella vaccines as a priority due to its severe impact, particularly on children in Low- and Middle-Income Countries (LMICs). The disease also poses a risk to international travelers and military personnel in areas where it is endemic.

Thomas Lingelbach, CEO of Valneva, highlighted the urgent need for a Shigella vaccine, given the disease's extensive impact and current lack of prophylactic solutions. He emphasized that the FDA's Fast Track designation would strengthen their collaboration with the FDA to expedite the development of S4V, aiming to provide a preventative measure against this critical health threat.

Dr. Franz-Werner Haas, CEO of LimmaTech, expressed optimism about the Fast Track designation, viewing it as a reinforcement of their efforts to address a major global health issue. The recognition underscores the significant potential of the S4V vaccine candidate in combating Shigella infections.

Shigellosis is responsible for an estimated 165 million cases and approximately 600,000 deaths annually, with a substantial proportion of cases occurring among children under five years old. The conventional treatment for shigellosis involves oral rehydration and antibiotics, but the increasing antibiotic resistance among Shigella strains complicates treatment efforts. The development of a vaccine is thus critical in addressing this challenge.

In August 2024, Valneva and LimmaTech entered a strategic partnership to develop, manufacture, and commercialize S4V. Following promising Phase 1/2 trial results earlier in the year, LimmaTech plans to conduct a Phase 2 Controlled Human Infection Model (CHIM) study in the U.S. and a Phase 2 pediatric study in LMICs, both expected to commence before the end of 2024. Valneva will be responsible for all subsequent development stages, including chemistry, manufacturing, and regulatory activities, as well as the global commercialization of the vaccine, if approved.

The regulatory strategy for S4V will utilize CHIM studies to seek initial approval for adults, followed by field efficacy studies aimed at extending the vaccine's use to children. This approach aims to comprehensively address the significant burden of shigellosis across different population groups.

Valneva has a history of successfully advancing vaccines from early research to market approval and currently offers three proprietary travel vaccines. Among their projects is the only advanced clinical candidate for a Lyme disease vaccine developed in partnership with Pfizer, as well as the world's most advanced Shigella vaccine candidate. Their efforts extend to potential vaccines for Zika virus and other pressing public health issues.

LimmaTech Biologics is recognized for its innovative vaccine technologies addressing antimicrobial resistance. With a strong pipeline and proprietary platforms, LimmaTech is committed to developing vaccines that provide robust protective solutions against challenging microbial infections. The company benefits from support by specialized healthcare investors, positioning it as a leader in the field of vaccine development.