In August 2024 Valneva and LimmaTech announced that they have entered a strategic partnership and exclusive licensing agreement for the development, manufacture, and commercialisation of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis. LimmaTech will receive an upfront payment of €10 million and will be eligible to receive further regulatory, development, and sales-based milestone payments as well as royalties on sales. LimmaTech will lead on a Phase II Controlled Human Infection Model (CHIM) and a Phase II paediatric study in low- and middle-income countries (LMICs). These trials are expected to begin in the second half of 2024. Valneva will cover other areas of development, including CMC (chemistry, manufacturing, and controls) and regulatory activities, as well as worldwide commercialisation if approved.
Shigellosis
Shigellosis is caused by the Gram-negative Shigella bacteria. In 2016 it was the second-leading cause of diarrhoeal mortality across all ages. The US CDC suggests that it causes an estimated 80 million – 165 million cases of disease and 600,000 deaths annually; most of these are among children. The development of Shigella vaccines is a WHO priority, but there is currently no approved vaccine. Valneva estimates that the global market for a vaccine against Shigella exceeds $500 million annually. Standard treatment for shigellosis is oral rehydration and antibiotic therapy, but the bacteria have developed resistance to many antibiotics and there are reports of outbreaks of multidrug-resistant strains.
Shigella4V
LimmaTech signed a research collaboration agreement with GSK in 2015 to develop novel, bioconjugate antigen-based vaccines. Among them was a monovalent Shigella vaccine; after positive results in a proof-of-concept trial, LimmaTech and GSK initiated the development of a multivalent vaccine. In 2023 LimmaTech announced that it had in-licensed the candidate from GSK to lead further development. The candidate is a tetravalent bioconjugate vaccine targeting four predominant pathogenic Shigella serotypes. In February 2024 LimmaTech reported positive interim Phase I/II data for the S4V vaccine candidate, including a favourable safety and tolerability profile.
A promising programme
Thomas Lingelbach, Valneva’s CEO, is “very pleased” to partner with LimmaTech to advance the “promising programme in an area of high-unmet medical need”. He believes that the vaccine candidate enables a “potential first-in-class vaccine solution” for LMICs and travellers, representing a “potentially highly synergistic product”.
“The anticipated development path follows a staggered and risk-mitigated strategy, and hence allows and efficient capital allocation in line with our communicated plan of having a new R&D programme in Phase III by 2027.”
CEO of LimmaTech, Dr Franz-Werner Haas, is “excited to accelerate the programme” through the partnership with Valneva. The LimmaTech has taken the vaccine candidate from early discovery to “promising clinical data” and now welcomes Valneva’s “proven expertise” in late-stage development and commercialisation.
“This agreement underscores our capabilities to leverage LimmaTech’s proficiency in vaccine development with the best path to develop programmes 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.”
We look forward to welcoming senior representatives from both LimmaTech and Valneva to the Congress in Barcelona this October, so get your tickets to join us there and don’t forget to subscribe to our weekly newsletters here.
