Valneva and LimmaTech Biologics have signed a strategic partnership to further the development of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis.
Under the new deal, Valneva will give LimmaTech a €10m ($10.7m) upfront payment. The Switzerland-based company will later be eligible for additional regulatory, development, and sales-based milestone payments, as well as low double-digit royalties on sales.
LimmaTech will be responsible for conducting a Phase II controlled human infection model clinical study and a Phase II paediatric trial evaluating the S4V vaccine in lower and middle-income countries.
The company aims to initiate both clinical studies in H2 2024. After this, Valneva will take charge of the vaccine’s further development, including the chemistry, manufacturing, and controls (CMC), regulatory interactions, and global commercialisation plans.
LimmaTech initially developed S4V under a partnership with GSK and then in-licensed it from GSK in July 2023. This most recent deal adds to Valneva’s vaccine pipeline. Last year, the company received the first worldwide approval for a chikungunya vaccine with a November US Food and Drug Administration (FDA) approval. Other than its chikungunya vaccine, Valneva’s experimental pipeline currently consists of a Phase I Zika virus vaccine, VLA1601, and a Phase II Lyme disease vaccine, VLA15.
There are currently no approved vaccines for a shigella infection, which leads to an intestinal condition called shigellosis (bacillary dysentery). The World Health Organization (WHO) reported that shigella was the second leading cause of diarrhoeal mortality among people of all ages, accounting for 212,000 deaths.
Moreover, WHO has identified the development of a shigella vaccine as a priority action. According to GlobalData, there are currently ten experimental vaccine candidates in development for the prevention of shigellosis.
GlobalData is the parent company of Pharmaceutical Technology.
In a 1 August press release, Valneva’s CEO Thomas Lingelbach said: “The Shigella vaccine candidate enables a potential first-in-class vaccine solution for both low and middle-income countries (LMICs) and travellers and, as such, represents a potentially highly synergistic product for Valneva. The anticipated development path follows a staggered and risk-mitigated strategy, and hence allows an efficient capital allocation in line with our communicated plan of having a new R&D programme in Phase III by 2027.”
