• Initial pharmacological data shows significant T cell suppression and favorable safety profile at 0.9 mg/kg dose
• Potential efficacy of IMP761 in treating autoimmune diseases highlighted by substantial T cell activity reduction
• Single ascending dose levels to continue with 2.5, 7 and 14 mg/kg

Immutep Limited announced positive initial efficacy data and continued favorable safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. Through the highest dosing level to date (0.9 mg/kg of IMP761), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. Given the encouraging efficacy and safety, Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising therapeutic target for rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis. IMP761 is designed to enhance the 'brake' function of LAG-3 to silence dysregulated self-antigen-specific memory T cells and restore balance to the immune system. The Phase I trial is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, and additional data is expected in the second half of 2025.

Immutep is continuing with single ascending dose levels of IMP761 at 2.5, 7 and 14 mg/kg to further evaluate the potential efficacy and safety of the first-in-class LAG-3 agonist antibody in treating autoimmune diseases.