Bharat Biotech to advance development of GSK's Shigella vaccine candidate for severe bacterial diarrhea
Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and manufacturing, today announced that it has partnered with GSK plc for the ongoing development and potential use of the Shigella vaccine candidate, altSonflex1-2-3. Shigellosis is a severe form of bacterial diarrhoea that disproportionately affects children under five in low- and middle-income countries.
Promising Early Clinical Results for altSonflex1-2-3
• The in-licensed candidate, altSonflex1-2-3, has demonstrated encouraging early-stage clinical trial results.
• Phase 1 study in Europe showed a favorable safety profile and strong immune response.
• Phase 2 trials in Africa, including testing in 9-month-old infants, reported no safety concerns.
• Interim results from 2024 confirmed that the candidate met its immunogenicity goals.
Development of altSonflex1-2-3 vaccine candidate
• The altSonflex1-2-3 vaccine candidate, developed by GSK and now advancing through a strategic collaboration with Bharat Biotech, represents one of the most advanced Shigella vaccine candidates globally.
• With no licensed Shigella vaccine currently available and rising antimicrobial resistance, this candidate stands out for its broad serotype coverage, innovative Generalized Modules for Membrane Antigens (GMMA)-based platform, and robust early clinical results.
• It has already demonstrated a strong safety and immunogenicity profile in both European and African trials, including in the primary target population of 9-month-old infants.
GMMA technology
GMMA technology is an innovative platform and the approach allows for high-yield production with a simple and cost-effective manufacturing process, offering a pathway to create affordable vaccines for underserved populations.
Dr. Krishna Ella, executive chairman, Bharat Biotech, said, ""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. 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.""
Terms of agreement
• 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.
• Thomas Breuer, chief global health officer, GSK, 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.”
• We 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."
• Shigella is a leading cause of child morbidity and mortality globally.
• The rise of drug-resistant strains highlights the urgent need for a preventive vaccine.
• By reducing illness and antibiotic use, the vaccine could play a critical role in fighting antimicrobial resistance (AMR).
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