Valneva and LimmaTech Biologics have entered into a strategic partnership and exclusive licensing agreement aimed at accelerating the development of a Shigella vaccine candidate.
There is currently no vaccine approved for Shigella, the second leading cause of fatal diarrhoeal disease globally.
It places a particularly high burden on children in low- and middle-income countries (LMICs), and the development of Shigella vaccines has been identified as a priority by the World Health Organization.
The new agreement gives Valneva an exclusive global licence for LimmaTech’s Shigella4V, a tetravalent bioconjugate vaccine that has already shown promise in a phase 1/2 trial.
According to interim data from the study shared by the biotech earlier this year, the candidate demonstrated a favourable safety and tolerability profile as well as significant immunogenicity against the four most common pathogenic Shigella serotypes.
LimmaTech will now conduct a phase 2 controlled human infection model and a phase 2 paediatric study of the vaccine in LMICs, which are both expected to begin later this year, while Valneva will assume all further development and regulatory activities and will be responsible for its commercialisation globally if approved.
In exchange, LimmaTech will receive an upfront payment of €10m and will be eligible for additional regulatory, development and sales-based milestone payments, as well as low double-digit royalties on sales.
Valneva’s chief executive officer, Thomas Lingelbach, said: “We are very pleased to partner with LimmaTech to advance a promising programme in an area of high unmet medical need.
“The Shigella vaccine candidate enables a potential first-in-class vaccine solution for both LMICs and travellers and, as such, represents a potentially highly synergistic product for Valneva.”
LimmaTech initiated Shigella4V and continued to lead its development as part of its ongoing collaboration with GSK, which it later in-licensed the candidate from.
Commenting on the latest agreement for the vaccine, Dr Franz-Werner Haas, the company’s chief executive officer, said: “Having developed the S4V Shigella vaccine candidate from its early discovery phase to the promising clinical data we achieved to date, we are excited to accelerate the programme with our partnership with Valneva.
“[Its] proven expertise in late-stage development and commercialisation of vaccines will expedite potential market approval and bring a Shigella vaccine to people in need.”