2 days ago
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.
