Exhibit 99.1
Immutep Announces Initial Safety Data from First-in-Human Phase I Trial Evaluating IMP761
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Favourable safety profile for world’s first LAG-3 agonist, IMP761,
with no treatment related adverse events to date |
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Additional safety data and assessment of PK/PD relationships to follow in first half of CY2025
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IMP761 is designed to enhance the “brake” function of
LAG-3 on T cells to restore balance to the immune system and address the underlying cause of many autoimmune diseases |
SYDNEY, AUSTRALIA – 17 December 2024 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the
Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces 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.
Dr. Frédéric Triebel, CSO of Immutep, said: “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. 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, 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 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.1,2,3 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.4,5
For more information on the trial, please visit clinicaltrials.gov (NCT06637865).
About IMP761
IMP761, a first-in-class immunosuppressive lymphocyte-activation gene-3 (LAG-3) agonist antibody, has the potential to address the root
cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. As published in the Journal of Immunology, encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-
