Immutep Announces Initial Efficacy Data And Continued Safety Data From Placebo-Controlled, Double-Blind First-In-Human Phase I Study Evaluating IMP761, LAG-3 Agonist Antibody For Autoimmune Diseases

• Initial pharmacological data from placebo-controlled, double-blind Phase I study shows significant T cell suppression and a favourable safety profile at dosing level of 0.9 mg/kg
• The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases
• Single ascending dose levels will continue with 2.5, 7 and 14 mg/kg
• Additional data from the Phase I to follow in second half of CY2025

 SYDNEY, AUSTRALIA, June 23, 2025 (GLOBE NEWSWIRE) --  Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces positive initial efficacy data and continued favourable 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 in multiple publications.1-3  IMP761 is the first LAG-3 agonist antibody developed to potentially treat these large and growing disorders, each of which represent multi-billion dollar markets, and many other autoimmune diseases. By enhancing the "brake" function of LAG-3 to silence dysregulated self-antigen-specific memory T cells, IMP761 is designed to target the cause of autoimmune diseases and restore balance to the immune system.