Full Press Release Details
Immutep Announces Initial Safety Data from First-in-Human Phase I Trial Evaluating IMP761
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. Fr d ric 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
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).
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-
induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile
idiopathic arthritis (o-JIA) published in Pediatric Research details how IMP761 led to a decrease in a broad spectrum of effector cytokines in just 48 hours. This study also showed
children with o-JIA have a skewed LAG-3 metabolism and suggested they can benefit from agonistic LAG-3 activity.
Immutep is a clinical-stage biotechnology
company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its
expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
+61 (0)406 759 268; catherine.strong@sodali.com
Chris Basta, VP, Investor Relations and
Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
This announcement was authorised for release by the CEO of Immutep Limited.
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