LimmaTech Biologics announces the start of a Phase I/II trial of a novel Klebsiella vaccine candidate

LimmaTech Biologics AG today announced the start of a Phase I/II clinical trial in Germany of a 4-valent candidate vaccine to help prevent Klebsiella infections. LimmaTech is developing the asset in collaboration with GSK.

Klebsiella is a bacterium threatening humans in many different settings, including hospitals and in the community, often related to infections of the blood, urinary tract, or lungs. These infections can be severe and are associated with high mortality in intensive care units, infants, elderly, hospitalized patients, immunocompromised, and those with chronic diseases. Both the World Health Organization and the United States Centers for Disease Control and Prevention (CDC) list Klebsiella as a priority for urgent intervention due to the alarming increase in antibiotic resistance. Without new antibiotics, the first effective vaccine against Klebsiella would be a very significant advance.

To help address this serious threat, LimmaTech and GSK have developed a tetravalent bioconjugate vaccine. It includes O-antigens (to target the serogroups causing the most infections) combined with GSK’s proprietary adjuvant system, which has already demonstrated it can provide strong immune responses in people of all ages including older adults. The Phase I/II study has received approval from the German regulatory agency (Paul Ehrlich Institute) and this week marked the start of the randomized, observer-blind, placebo-controlled clinical trial. The primary objectives of the study are the safety and tolerability of the vaccine as well as the immunogenicity.

Dr. Patricia Martin, Managing Director, Clinical and Regulatory Affairs of LimmaTech commented: “In these challenging times, with increasing antimicrobial resistance (AMR), it is imperative that we keep looking for alternatives to antibiotics. Vaccines have proven to be the most important tool to prevent infections and stop the spread of disease.” Dr. Martin further noted: “This Klebsiella vaccine is another example of the success of our over nine-years collaboration which combines the complementary expertise of GSK and LimmaTech.”

Dr Rino Rappuoli, Head of Vaccines R&D at GSK, highlighted: “COVID-19 has shown that vaccine platform technologies can be instrumental to develop innovative tools to help protect people against emerging infectious diseases – and AMR is one of the biggest growing health threats globally. At GSK, we’re committed to using our scientific expertise and novel technologies, such as adjuvants and bioconjugation, and collaborate with our partners to contribute to the global response against AMR”.