GSK has licensed its shigella vaccine candidate to Bharat Biotech. The Big Pharma, which has vowed to help Bharat with trial design and fundraising, framed the deal as a way to get the vaccine to patients in low- and middle-income countries where the pathogen is a health threat.
Shigella, a type of bacteria, is a leading cause of death from diarrhea. While antibiotics are available, the bacteria is estimated to be responsible for the deaths of tens of thousands of children under 5 years of age in low- and middle-income countries every year. The recent rise of strains that are resistant to many antibiotics has ratcheted up the need for a vaccine.
GSK developed altSonflex1-2-3 to address the unmet need. Phase 1 and interim phase 2 data met GSK’s immunogenicity success criteria, the London-based drugmaker said. Yet, GSK has decided to hand off to India’s Bharat for the phase 3 trial.
Thomas Breuer, chief global health officer at GSK, said in a statement that Bharat’s “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.” GSK licensed its malaria vaccine, RTS,S, to Bharat in 2021.
After the shigella technology transfer, GSK will work with Bharat to design the phase 3 trial and support its partner’s search for external funding. The Bill & Melinda Gates Foundation supported GSK’s clinical development of the malaria vaccine RTS,S.
GSK has taken steps to keep the cost of making the vaccine low. The candidate uses GMMA technology, a platform that repurposes vesicles from bacteria to deliver antigens. One study found that a 500L fermenter could make 100 million doses of a GMMA vaccine a year for $1 each.
The deal marks the second time in two years that GSK has offloaded a shigella vaccine candidate. In 2023, the drugmaker returned the rights to another vaccine to LimmaTech Biologics. LimmaTech went on to license the candidate to Valneva, which is now racing GSK and Bharat to market.