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Hyderabad-based Bharat Biotech International Limited (BBIL) has partnered with GSK plc for the ongoing development and potential use of the Shigella vaccine candidate, altSonflex1-2-3.
The agreement marks a critical step in the advancement of this promising vaccine, targeting Shigellosis, a severe form of bacterial diarrhoea that disproportionately affects children under five in low- and middle-income countries.
The in-licensed candidate, altSonflex1-2-3, has already shown encouraging results in early-stage clinical trials. A Phase 1 study conducted in Europe demonstrated a favourable safety profile and strong immune response. Subsequent Phase 2 trials in Africa, including vaccination of 9-month-old infants—the primary target population—reported no safety concerns. Interim results from 2024 confirmed that the candidate met its pre-set immunogenicity goals.
The altSonflex1-2-3 vaccine candidate, developed by GSK and now advancing through a strategic collaboration with Bharat Biotech, represents one of the most advanced Shigella vaccine candidates globally.
With no licensed Shigella vaccine currently available and rising antimicrobial resistance, this candidate stands out for its broad serotype coverage, innovative Generalized Modules for Membrane Antigens (GMMA)-based platform, and robust early clinical results. It has already demonstrated a strong safety and immunogenicity profile in both European and African trials, including in the primary target population of 9-month-old infants.
Now entering Phase 3 trials under Bharat Biotech’s leadership, altSonflex1-2-3 is poised to become the first scalable, affordable, and globally accessible vaccine to combat this urgent public health threat.
GSK will continue to support the programme by assisting with clinical trial design, securing external funding, and contributing to the Access and Delivery Plans and commercialisation strategy.
GMMA technology is an innovative platform that uses bacterial outer membranes to deliver the O Antigen to the immune system. This novel approach allows for high-yield production with a simple and cost-effective manufacturing process, offering a pathway to create affordable vaccines for underserved populations.
