Hyderabad: Bharat Biotech International Limited (BBIL), a leading vaccine manufacturer based in Hyderabad, has announced a major partnership with global pharmaceutical giant GSK plc to advance the development of altSonflex1-2-3, an innovative vaccine candidate targeting Shigellosis—a severe form of bacterial diarrhoea that poses a significant threat to children under five, especially in low- and middle-income countries.
Under the agreement, Bharat Biotech has in-licensed the vaccine candidate from GSK, which has already completed Phase I and II clinical trials in Europe and Africa.
These early-stage trials demonstrated a favourable safety profile and strong immune response, with no safety concerns reported in African infants as young as nine months—the primary target population. Interim results from 2024 confirmed that the vaccine met its pre-set immunogenicity goals.
Bharat Biotech will now take the lead on further development, including Phase III clinical trials, regulatory advancement, and large-scale manufacturing. GSK will continue to support the project by assisting with clinical trial design, securing external funding, and contributing to strategies for access, delivery, and commercialisation.
The altSonflex1-2-3 vaccine has been developed using the Generalised Modules for Membrane Antigens (GMMA) platform, which utilises bacterial outer membranes to deliver the O Antigen to the immune system.
This innovative approach offers broad serotype coverage and is considered one of the most advanced Shigella vaccine candidates globally.
Currently, there is no approved vaccine for Shigella, despite the rising threat of antimicrobial resistance and the significant disease burden in vulnerable populations.
Bharat Biotech’s Executive Chairman, Dr. Krishna Ella, emphasised the urgent need for scalable, science-backed solutions for low- and middle-income countries.
He highlighted Bharat Biotech’s existing expertise in vaccines for diarrhoeal diseases, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi.
GSK’s Chief Global Health Officer, Thomas Breuer, noted that the collaboration combines GSK’s scientific innovation with Bharat Biotech’s manufacturing capabilities, aiming to accelerate the delivery of a much-needed vaccine to prevent illness and save lives worldwide,
