GSK has entered into a licensing agreement with Bharat Biotech International Limited (BBIL) for its Shigella vaccine candidate, altSonflex1-2-3.
The partnership aims to advance the development and potential distribution of the vaccine in low- and middle-income countries, where Shigella is a leading cause of diarrhoea among children under five.
The vaccine candidate has shown promising results in Phase 1 trials and interim analyses from Phase 2 trials, meeting pre-set immunogenicity success criteria.
The Shigella vaccine utilises GMMA technology, a platform developed by GSK’s Global Health team. The technology employs outer membrane vesicles (OMVs) from bacteria to deliver antigens that activate the immune system.
GMMA technology is cost-effective and scalable, making it suitable for producing vaccines for low-income regions. It often stimulates a strong immune response without adjuvants and can target various bacterial diseases, including Shigella.
The rise of antimicrobial-resistant enteric bacteria, such as Shigella, underscores the potential impact of a Shigella vaccine. It could help reduce illness and mortality rates while indirectly decreasing antibiotic use and addressing antimicrobial resistance (AMR).
Following the technology transfer, GSK will work with BBIL on the Phase 3 trial design and support BBIL in securing external funding. This collaboration builds on a previous agreement in 2021 between GSK and the Indian biotech firm for the malaria vaccine, RTS,S.
GSK chief global health officer Thomas Breuer said: “With young children in lower-income countries disproportionately impacted by Shigella, the development of a low-cost vaccine is an important goal for global public health.
“With no licensed vaccines widely available, the development of our Shigella vaccine candidate which has demonstrated promising clinical trial results, fills us with immense pride.
“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.”
