Latest news with #GMMA
Hindustan Times
8 hours ago
- Health
- Hindustan Times
Health Talk: Bharat Biotech-GSK's Shigella vaccine candidate holds promise
Hyderabad-based Bharat Biotech has partnered with GSK—a British multinational pharmaceutical and biotechnology company—for the ongoing development and potential use of the Shigella vaccine candidate, altSonflex1-2-3, the companies announced in a joint statement on Thursday. The partnership will mark a critical step in the advancement of this promising vaccine, targeting Shigellosis—a severe form of bacterial diarrhoea that disproportionately affects children under five in low- and middle-income countries. India is also impacted. A 2021 study published in the Indian Journal of Medical Biology— Antimicrobial Resistant Shigella in North India Since the Turn of the 21st Century — talks about how the ubiquitous presence and rampant spread of Shigellosis in Asian and African countries, along with the emergence of antibiotic-resistant strains, is particularly concerning. 'The scientific community must focus efforts to identify the drugs most suitable for empirical therapy according to these antibiograms. To decrease the morbidity and mortality associated with diarrhea in our country, we not only need newer antimicrobials, cost-effective vaccines but also public health measures such as safe drinking water and sanitation…,' concluded researchers in the paper. Talking about the partnership, Bharat Biotech executive chairman Krishna Ella 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. This collaboration combines our strengths in innovation, manufacturing, and global health commitment. The use of Generalised Modules for Membrane Antigens (GMMA) technology reflects our mission to deliver accessible vaccines that protect and improve lives worldwide,' Ella added. According to the statement issued, 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. 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 read. The vaccine candidate 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 GMMA-based platform, and robust early clinical results. GMMA technology is an innovative platform that uses bacterial outer membranes to deliver the O Antigen to the immune system. This approach allows for high-yield production with a simple and cost-effective manufacturing process, offering a pathway to create affordable vaccines for underserved populations. As part of this agreement, Bharat Biotech will lead the further development of the vaccine candidate, 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 commercialisation strategy. '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,' GSK chief global health officer Thomas Breuer said. Having effective vaccines, which are also cost-effective, can reduce the overall disease burden significantly.
The Hindu
2 days ago
- Health
- The Hindu
GSK partners with Bharat Biotech for Shigella vaccine
Hyderabad-based vaccine maker Bharat Biotech International and global biopharma major GSK have announced a collaboration to advance development of latter's Shigella vaccine candidate altSonflex1-2-3. Under their agreement, Bharat Biotech will lead further development of altSonflex1-2-3, including the 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 commercialisation strategy, the companies said on Thursday, June 12. Shigellosis is an acute human inflammatory disease of the large intestine caused by Gram-negative Shigella. It is characterised by watery diarrhoea, fever, abdominal cramps and pain, and bloody and mucus-filled stools. There is no licenced Shigella vaccine currently available. Now entering Phase 3 trials altSonflex1-2-3 is poised to become the first scalable, affordable and globally accessible vaccine to combat this urgent public health threat, Bharat Biotech said on the in-licensed vaccine candidate. GSK's vaccine candidate stands out for its broad serotype coverage, innovative Generalized Modules for Membrane Antigens (GMMA)-based platform and robust early clinical results. It has demonstrated a strong safety and immunogenicity profile in both European and African trials, including in the primary target population of 9-month-old infants, it said. A Phase 1 study in Europe demonstrated a favourable safety profile and strong immune response. Subsequent Phase 2 trials in Africa, including vaccination of nine-month-old infants, the primary target population, reported no safety concerns. Interim results from 2024 confirmed the vaccine candidate met its pre-set immunogenicity goals. 'This collaboration [Shigella vaccine] 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,' Bharat Biotech executive chairman Krishna Ella said in a release. GMMA technology uses bacterial outer membranes to deliver the O Antigen to the immune system. This approach allows for high-yield production with a simple and cost-effective manufacturing process, offering a pathway to create affordable vaccines for underserved populations, the company said. GSK's chief global health officer Thomas Breuer said 'the 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'. The collaboration builds on GSK's existing relationship with Bharat Biotech, following a product transfer and license agreement in 2021 for the world's first malaria vaccine, RTS,S.
