LimmaTech signs in-license agreement with GSK

Shigellosis is a serious diarrheal infection and global health threat with a major impact in low- and middle-income countries where mortality and morbidity are high. Currently, no vaccines help prevent shigellosis. It is estimated that about 188 million infections are due to Shigella of which 62.3 million cases occur in children younger than 5 years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travellers and deployed military personnel in endemic regions. There are 600,000 deaths attributed to Shigella each year, and it is the second leading cause of diarrheal deaths.

The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, which makes treatment extremely difficult. Currently, no licensed Shigella vaccine is available. With the pathogen developing resistance to the antibiotics used to treat it, a vaccine is urgently needed in order to prevent the disease.

Clinical advancement for Shingella bioconjugate vaccine
LimmaTech Biologics AG has signed a research collaboration agreement with GSK to develop novel bioconjugate antigen-based vaccines, including a monovalent Shigella vaccine, in cooperation with the Wellcome Trust. Following positive results from the proof-of-concept human challenge clinical trial with the monovalent Shigella vaccine, LimmaTech initiated the development of a multivalent Shigella vaccine in 2018 with a Wellcome Trust grant received by GSK for the new program.

The multivalent vaccine candidate is composed of antigens from the four most epidemiologically relevant Shigella bacterial strains. It is being tested in an ongoing Phase I/II dose-finding and age-descending (adults-children-infants) double-blind study to evaluate its safety and immunogenicity in the 9-month-old infants target population. The results from the Phase I/II study are expected in 2023. A positive outcome for safety and immunogenicity will support the further development of the vaccine with pivotal efficacy trials in the target pediatric population as well as travellers and military personnel travelling to Shigella endemic countries.

Thomas Breuer, Chief Global Health Officer at GSK, said, “LimmaTech will give this candidate vaccine the greatest chance of success while GSK continues to use its expertise to progress another vaccine in clinical development using a GSK proprietary vaccine platform technology called GMMA. Having more than one vaccine could improve supply security and enable countries to implement the one that best suits their particular needs. Together, we can get ahead of Shigella.”

LimmaTech Biologics spun out from GlycoVaxyn after that company’s acquisition by GSK. LimmaTech applies its deep know-how of engineering complex carbohydrate molecules to develop next-generation vaccines to prevent life-threatening diseases. The company is advancing its own proprietary clinical pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance and sexually transmitted infections such as gonorrhea, alongside partnered programs with GSK.

(Press release/RAN)