Valneva(US:VALN) Newsfilter·2024-08-01 05:00Core Insights - Valneva has secured an exclusive worldwide license for LimmaTech's S4V Shigella vaccine candidate, enhancing its R&D pipeline with a promising Phase 2 clinical asset [1][3] - Shigellosis, caused by Shigella bacteria, is a significant global health issue, leading to approximately 165 million infections and 600,000 deaths annually, particularly affecting children in low- and middle-income countries [2][5] - The global market for a Shigella vaccine is projected to exceed $500 million annually, indicating a substantial commercial opportunity [2][3] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, with a strong track record in advancing vaccines from early R&D to market [7] - LimmaTech Biologics AG specializes in vaccine technology and is dedicated to combating antimicrobial resistance, leveraging its proprietary vaccine platform to develop solutions for microbial infections [8] Agreement Details - Under the licensing agreement, LimmaTech will receive an upfront payment of €10 million and is eligible for additional milestone payments and royalties on sales [3] - LimmaTech will conduct a Phase 2 Controlled Human Infection Model and a Phase 2 pediatric study in low- and middle-income countries, with trials expected to start in the second half of 2024 [3] - Valneva will manage all further development and commercialization efforts if the vaccine is approved [3][4] Clinical Development - The S4V vaccine candidate has shown positive interim Phase 1/2 data, demonstrating a favorable safety profile and robust immunogenicity against the four most common pathogenic Shigella serotypes [4][6] - The anticipated development strategy is designed to be staggered and risk-mitigated, aligning with Valneva's goal of advancing a new R&D program into Phase 3 by 2027 [4]