Bharat Biotech Secures In-Licensing Agreement for GSK’s Shigella Vaccine Candidate
Vaccine manufacturer Bharat Biotech International Limited (BBIL) has secured the rights to develop GSK’s promising Shigella vaccine candidate, altSonflex1-2-3. This vaccine aims to combat Shigellosis, a severe bacterial infection that primarily affects young children in low- and middle-income countries. Following successful Phase I and II trials conducted by GSK in Europe and Africa, Bharat Biotech will now advance the candidate into Phase III clinical trials, regulatory processes, and large-scale production.
Collaboration and Development Plans
Under the agreement, GSK will continue to support Bharat Biotech throughout the development process. This collaboration includes assistance with clinical trial design, securing external funding, and formulating strategies for access, delivery, and commercialization of the vaccine. Bharat Biotech has expressed confidence in the vaccine’s potential, citing encouraging results from early-stage clinical trials. The Phase I study in Europe demonstrated a favorable safety profile and a robust immune response, while Phase II trials in Africa, which included vaccinations for infants, reported no safety concerns. Interim results from 2024 confirmed that the vaccine met its immunogenicity goals.
Addressing a Critical Health Need
Dr. Krishna Ella, executive chairman of Bharat Biotech, emphasized the urgent need for effective solutions against Shigella, especially given the rising issue of antimicrobial resistance. He highlighted that there are currently no approved vaccines for Shigella, making this development particularly crucial for low and middle-income countries. The collaboration aims to leverage Bharat Biotech’s strengths in innovation and manufacturing to address this significant public health challenge. The addition of the Shigella vaccine candidate will enhance Bharat Biotech’s existing portfolio, which already includes vaccines for various diarrheal infections such as rotavirus, typhoid, and cholera.
Previous Collaborations with GSK
Bharat Biotech’s partnership with GSK is not new; the two companies previously collaborated on the world’s first malaria vaccine, RTS,S, in 2021. This established relationship lays a strong foundation for the current project, as both companies share a commitment to advancing global health initiatives. The collaboration on the Shigella vaccine reflects a continued effort to address infectious diseases that disproportionately affect vulnerable populations, particularly children in developing regions. With the ongoing support from GSK, Bharat Biotech is poised to make significant strides in the fight against Shigellosis.
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