Valneva leverages LimmaTech's leading Shigella vaccine candidate

Valneva has established a strategic partnership and exclusive licensing agreement with LimmaTech Biologics to acquire the rights to LimmaTech's vaccine candidate, Shigella4V (S4V), which targets shigellosis. Shigellosis is a severe intestinal infection caused by Shigella bacteria. According to Thomas Lingelbach, Valneva's CEO, the Shigella vaccine candidate is poised to become a first-in-class vaccine solution, representing a highly synergistic product.

In the agreement revealed on Thursday, LimmaTech will receive an initial payment of €10 million (approximately $10.8 million) and be eligible for further milestone payments based on regulatory progress, development achievements, and sales performance. Additionally, LimmaTech will benefit from low double-digit royalties on future sales of the vaccine. LimmaTech is set to conduct two mid-stage clinical studies of S4V, which are anticipated to start later this year. Valneva will oversee all subsequent development, regulatory processes, and global commercialization of the vaccine once it gains approval. Lingelbach mentioned that the company plans to implement a Phase III program by 2027.

Initially, LimmaTech teamed up with GSK in 2015 to develop the tetravalent bioconjugate vaccine candidate. The candidate was subsequently in-licensed by LimmaTech last year. Interim data from Phase I/II trials, which were reported in February of this year, indicated that S4V has favorable safety, tolerability, and immunogenicity profiles against the four most prevalent pathogenic Shigella serotypes.

Valneva's current vaccine portfolio includes approved vaccines for Japanese encephalitis, cholera, traveler's diarrhea, and hepatitis B. Furthermore, the company has recently received approvals for its chikungunya vaccine, Ixchiq, in the US, Canada, and the European Union. Valneva's developmental pipeline is also robust, featuring VLA15 for Lyme disease, in collaboration with Pfizer, and VLA1601 for the Zika virus.

The collaboration between Valneva and LimmaTech aims to bring a much-needed vaccine for shigellosis to the market. Shigellosis poses a significant health challenge, especially in regions with limited access to clean water and sanitation. The potential introduction of an effective vaccine could have a substantial impact on global health, reducing the incidence of this debilitating disease.

Overall, the partnership represents a strategic move for both companies. For LimmaTech, it provides the necessary financial backing and development expertise to advance the Shigella vaccine candidate through the crucial stages of clinical development. For Valneva, it enhances their already diverse portfolio of vaccines, aligning with their mission to address unmet medical needs through innovative vaccine solutions. The success of this collaboration could pave the way for future partnerships and advancements in the field of infectious diseases.