• Favourable safety profile for world's first LAG-3 agonist, IMP761, with no treatment related adverse events to date
• Additional safety data and assessment of PK/PD relationships to follow in first half of CY2025
• IMP761 designed to enhance the 'brake' function of LAG-3 on T cells to restore balance to the immune system

Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies, today announced favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. Through the first three of five single ascending dose cohorts in healthy participants, there have been no treatment related adverse events. IMP761 is a first-in-class immunosuppressive lymphocyte-activation gene-3 (LAG-3) agonist antibody designed to restore balance to the immune system by enhancing the 'brake' function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. Preclinical studies have shown IMP761 leads to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell-mediated immune responses. The trial in up to 49 participants is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, and in addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761's pharmacological activity. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships are expected to follow in the first half of CY2025.

Given that IMP761 is potentially addressing the root cause of many different autoimmune diseases, the company is eager to see this study generating more data.