Bharat Biotech in-licenses GSK vaccine candidate for bacterial diarrhoea

Hyderabad based vaccine maker Bharat Biotech International Limited (BBIL) has in-licensed a potential vaccine candidate for Shigellosis, a severe form of bacterial diarrhoea that disproportionately affects children under five in low- and middle-income countries, from global pharmaceutical major GSK Plc.

BBIL will conduct further clinical trials of the vaccine candidate and, if successful, carry out large scale manufacturing.

The in-licensed candidate, altSonflex1-2-3, has already shown encouraging results in early-stage clinical trials, the company said in a statement. While a Phase 1 clinical trial 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 company claimed.

"As the market leader in vaccines for diarrhoeal infections, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi, Bharat Biotech is proud to partner with GSK to develop a next-generation Shigella vaccine candidate, for a severe form of bacterial diarrhoea affecting millions of children under five”, said Krishna Ella, Executive Chairman, Bharat Biotech.

“With no approved vaccine currently available 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. The use of GMMA technology reflects our mission to deliver accessible vaccines that protect and improve lives worldwide", he added.

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, the company said in the statement.

As part of this agreement, Bharat Biotech will lead the further development of altSonflex1-2-3, including Phase 3 clinical trials, regulatory advancement, and large-scale manufacturing. 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 commercialization strategy. GSK has an established relationship with BBIL, after signing a product transfer agreement for the world’s first malaria vaccine, RTS,S, to the Indian Biotech company in 2021.

“We are proud to collaborate with Bharat Biotech, whose expertise in developing and supplying vaccines for infectious diseases, especially as a trusted supplier to Gavi, the Vaccine Alliance, and UNICEF, positions them to further advance this important work. This agreement allows us to combine our strengths in science, research, and technology with Bharat Biotech's capacity to develop and deliver vaccines at scale, potentially preventing illness and saving lives around the world", Thomas Breuer, Chief Global Health Officer, GSK, said.