Valneva and LimmaTech have signed an exclusive licensing and partnership agreement for the development of a shigellosis vaccine. Credit: SOPA Images via Getty images.
Valneva
and LimmaTech Biologics have signed a strategic partnership to further the development of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis.
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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.
See Also:
HilleVax slashes workforce by 40% after norovirus vaccine trial failure
Molecure and Avicenna link to develop cancer drugs
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.”
Free Report
How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
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