Clinical-stage biotechnology company Immutep (ASX: IMM) has received 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.
"We are very encouraged by the safety data generated to date for IMP761, the world’s first LAG-3 agonist antibody, in this Phase I setting," D. Frédéric Triebel, CSO of Immutep, said.
"Derisking this promising asset in this proof-of-concept study in healthy subjects assessing its safety and immunosuppressive efficacy on an antigen- specific T-cell mediated intra-dermal reaction is an important step for this exciting program in autoimmune diseases. Given that IMP761 is potentially addressing the root cause of many different autoimmune diseases, we are eager to see this study generating more data.”
The trial in up to 49 participants is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, the trial is being used to evaluate IMP761’s pharmacological activity. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025.
The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising target for an agonist antibody to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among potentially many other autoimmune diseases.This first-in-class agonist LAG-3 antibody is 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.
In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.