HYDERABAD: Vaccine maker Bharat Biotech International Limited (BBIL) has in-licenced pharma giant GSK’s Shigella vaccine candidate — altSonflex1-2-3.The vaccine candidate was being developed by GSK against Shigellosis, which is a severe form of bacterial diarrhoea that largely affects children aged five years and below in low- and middle-income countries.While GSK has already conducted Phase-I and II trials in Europe and Africa, Bharat Biotech will be taking up further development with Phase-III clinical trials, regulatory advancement and large-scale manufacturing, Bharat Biotech said on Thursday.As part of the agreement, GSK will continue its support to 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 generalized 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, 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,” the Hyderabad-based vaccine maker 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 the addition of this vaccine candidate to its portfolio will strengthen Bharat Biotech’s already significant presence in vaccines for diarrhoeal infections, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi.GSK already has an established relationship with BBIL, after it signed a product transfer agreement for the world’s first malaria vaccine, RTS,S, to the Hyderabad-based company in 2021.
