Hyderabad: Vaccine maker Bharat Biotech International Limited (BBIL) has in-licensed pharma giant GSK’s under development Shigella vaccine candidate, altSonflex1-2-3. The vaccine candidate was being developed by GSK against Shigellosis, a severe form of bacterial diarrhoea that largely affects children aged below five years in low- and middle-income countries.While GSK has already conducted Phase I and II trials in Europe and Africa, Bharat Biotech will take up further development with Phase III clinical trials, regulatory advancement, and large-scale manufacturing, the Hyderabad-based vaccine maker said on Thursday. As part of the agreement, 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.The vaccine has been developed on the innovative generalised modules for membrane antigens (GMMA) based platform, which uses bacterial outer membranes to deliver the O Antigen to the immune system.“The in-licensed candidate, altSonflex1-2-3, already showed encouraging results in early-stage clinical trials. A Phase 1 study conducted in Europe demonstrated a favourable safety profile and strong immune response,” Bharat Biotech said. “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,” it added.Bharat Biotech Executive Chairman Dr Krishna Ella said: “With no approved vaccine currently available for Shigella and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on low and middle-income countries. This collaboration combines our strengths in innovation, manufacturing, and global health commitment.” He pointed out that Bharat Biotech already has a significant presence in vaccines for diarrhoeal infections, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi.In 2021, GSK had inked a product transfer agreement for the world’s first malaria vaccine, RTS,S, with Bharat Biotech.
