Bharat Biotech in-licences GSK’s Shigella vaccine candidate

HYDERABAD: Vaccine maker Bharat Biotech International Limited (BBIL) has in-licenced pharma big GSK’s Shigella vaccine candidate — altSonflex1-2-3.The vaccine candidate was being developed by GSK in opposition to Shigellosis, which is a extreme type of bacterial diarrhoea that largely impacts kids aged 5 years and beneath in low- and middle-income nations.While GSK has already carried out Phase-I and II trials in Europe and Africa, Bharat Biotech shall be taking on additional improvement with Phase-III scientific trials, regulatory development and large-scale manufacturing, Bharat Biotech stated on Thursday.As a part of the settlement, GSK will proceed its assist to the programme by aiding with scientific trial design, securing exterior funding, and contributing to the entry and supply plans and commercialisation technique. The vaccine has been developed on the progressive generalized modules for membrane antigens (GMMA) primarily based platform, which makes use of bacterial outer membranes to ship 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 stated.“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 govt chairman Dr Krishna Ella stated: “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 identified that the addition of this vaccine candidate to its portfolio will strengthen Bharat Biotech’s already vital presence in vaccines for diarrhoeal infections, together with rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi.GSK already has a longtime relationship with BBIL, after it signed a product switch settlement for the world’s first malaria vaccine, RTS,S, to the Hyderabad-based firm in 2021.