India Pharma Outlook Team | Thursday, 12 June 2025
Bharat Biotech International Limited (BBIL) announces a strategic partnership with GSK plc to advance the development and distribution of the Shigella vaccine candidate, altSonflex1-2-3.
Shigellosis, a serious bacterial diarrhoeal disease, mainly affects children aged under five years in low- and middle-income countries, where treatment is increasingly complicated by increasing antimicrobial resistance (AMR).
Dr. Krishna Ella, executive chairman, Bharat Biotech, said, "As the market leader in vaccines for diarrhoeal infections, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi. Bharat Biotech is proud to partner with GSK to develop a next-generation Shigella vaccine candidate, for a severe form of bacterial diarrhoea affecting millions of children under five. With no approved vaccine currently available and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on low and middle-income countries."
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The altSonflex1-2-3 vaccine, developed by GSK, was found to have promising results in early clinical trials. Phase 1 trials in Europe indicated the vaccine candidates' safety and appropriate immune response; meanwhile, phase 2 trials which took place in Africa with infants aged 9-months-old (the target population) were supportive of its immunogenicity and safety. The vaccine uses GMMA (Generalized Modules for Membrane Antigens) technology, enabling high yield and cost-effective manufacturing to enable access globally.
Under this partnership agreement, Bharat Biotech will take the lead on Phase 3 trials, regulatory activities, and large-scale manufacturing. GSK will provide direct input into the design of the clinical trials, as well as funding and strategies for access. Bharat Biotech and GSK have collaborated previously on the world's first malaria vaccine.
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