Latest news with #altSonflex1-2-3
Time of India
a day ago
- Health
- Time of India
Bharat Biotech in-licences GSK's Shigella vaccine
Hyderabad: Vaccine maker Bharat Biotech International Limited (BBIL) has in-licensed pharma giant GSK's under development Shigella vaccine candidate, altSonflex1-2-3. The vaccine candidate was being developed by GSK against Shigellosis, a severe form of bacterial diarrhoea that largely affects children aged below five years in low- and middle-income countries. While GSK has already conducted Phase I and II trials in Europe and Africa, Bharat Biotech will take up further development with Phase III clinical trials, regulatory advancement, and large-scale manufacturing, the Hyderabad-based vaccine maker said on Thursday. As part of the agreement, 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 vaccine has been developed on the innovative generalised modules for membrane antigens (GMMA) based platform, which uses bacterial outer membranes to deliver the O Antigen to the immune system. "The in-licensed candidate, altSonflex1-2-3, already showed encouraging results in early-stage clinical trials. A Phase 1 study conducted in Europe demonstrated a favourable safety profile and strong immune response," Bharat Biotech said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Toulouse: Nous recherchons des personnes pour tester les nouvelles aides auditives HearPro En savoir plus Undo "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 Executive Chairman Dr Krishna Ella said: "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 pointed out that Bharat Biotech already has a significant presence in vaccines for diarrhoeal infections, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi. In 2021, GSK had inked a product transfer agreement for the world's first malaria vaccine, RTS,S, with Bharat Biotech. Follow more information on Air India plane crash in Ahmedabad here . Get real-time live updates on rescue operations and check full list of passengers onboard AI 171 .
Time of India
2 days ago
- Health
- Time of India
Bharat Biotech in-licences GSK's Shigella vaccine candidate
HYDERABAD: Vaccine maker Bharat Biotech International Limited (BBIL) has in-licenced pharma giant GSK's Shigella vaccine candidate -- altSonflex1-2-3. The vaccine candidate was being developed by GSK against Shigellosis, which is a severe form of bacterial diarrhoea that largely affects children aged five years and below in low- and middle-income countries. While GSK has already conducted Phase-I and II trials in Europe and Africa, Bharat Biotech will be taking up further development with Phase-III clinical trials, regulatory advancement and large-scale manufacturing, Bharat Biotech said on Thursday. As part of the agreement, GSK will continue its support to the programme by assisting with clinical trial design, securing external funding, and contributing to the access and delivery plans and commercialisation strategy. The vaccine has been developed on the innovative generalized modules for membrane antigens (GMMA) based platform, which uses bacterial outer membranes to deliver 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 said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Is it better to shower in the morning or at night? Here's what a microbiologist says CNA Read More Undo '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 executive chairman Dr Krishna Ella said: '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 pointed out that the addition of this vaccine candidate to its portfolio will strengthen Bharat Biotech's already significant presence in vaccines for diarrhoeal infections, including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi. GSK already has an established relationship with BBIL, after it signed a product transfer agreement for the world's first malaria vaccine, RTS,S, to the Hyderabad-based company in 2021. Stay informed with the latest business news, updates on bank holidays and public holidays . AI Masterclass for Students. Upskill Young Ones Today!– Join Now
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Business Standard
2 days ago
- Health
- Business Standard
Bharat Biotech signs pact with GSK to develop Shigella vaccine candidate
Bharat Biotech on Thursday announced its partnership with UK-based pharma company GSK for the development and potential use of the Shigella vaccine candidate altSonflex1-2-3. As part of the agreement, Bharat Biotech will lead the further development of altSonflex1-2-3, including Phase 3 clinical trials, regulatory advancement and large-scale manufacturing. GSK, on the other hand, will support the programme by assisting with clinical trial design, securing external funding and contributing to the access and delivery plans and commercialisation strategy. The company said that the agreement marks a significant step in advancing the vaccine, which targets shigellosis, a severe form of bacterial diarrhoea that disproportionately affects children under five years of age in low- and middle-income countries (LMICs). 'The vaccine candidate has already demonstrated a strong safety and immunogenicity profile in both European and African trials, including in the primary target population of nine-month-old infants,' it added. Commenting on the development, Krishna Ella, Executive Chairman at Bharat Biotech, said that with no approved vaccine currently available and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on LMICs. 'This collaboration combines our strengths in innovation, manufacturing and global health commitment.' According to the World Health Organisation (WHO), Shigella was the second-leading cause of diarrhoeal mortality in 2016 (latest data) among all ages and the leading bacterial cause of diarrhoea, accounting for approximately 212,000 deaths and about 13 per cent of all diarrhoea-associated deaths. The disease is a major contributor to child morbidity and mortality, and the emergence of drug-resistant strains underscores the urgent need for a preventive vaccine. The standard of care for shigellosis primarily involves managing dehydration and using antibiotics. While mild cases often resolve with rest and fluid replacement, more severe cases or those with weakened immune systems may benefit from antibiotics like ciprofloxacin or azithromycin. Thomas Breuer, Chief Global Health Officer at GSK, said that by helping reduce illness and antibiotic use, this vaccine has the potential to play a critical role in combating antimicrobial resistance (AMR). The companies claimed that the vaccine candidate has broad serotype coverage, an innovative Generalised Modules for Membrane Antigens (GMMA)-based platform and robust early clinical results. 'GMMA technology is a platform that uses bacterial outer membranes to deliver the O antigen to the immune system, allowing for high-yield production, which creates affordable vaccines for underserved populations,' they added in a statement.
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.
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Business Standard
2 days ago
- Health
- Business Standard
Bharat Biotech, GSK partner to develop vaccine for Shigella diarrhoea
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 Press Trust of India New Delhi Bharat Biotech on Thursday said it has partnered with GSK plc for the development of a vaccine for Shigellosis, a severe form of bacterial diarrhoea. 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, the company said in a statement. 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 added. "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," Bharat Biotech Executive Chairman Krishna Ella said. 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 commercialisation strategy. "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," GSK Chief Global Health Officer Thomas Breuer said.
