Full Press Release Details
Immutep Announces First Participant Dosed in Phase I Study
of IMP761, a First in Class Agonist LAG-3 Antibody
SYDNEY, AUSTRALIA 14 August 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 that the first participant has
been successfully dosed in the first-in-human Phase I trial of IMP761. 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.
The single and multiple ascending dose, placebo-controlled, double-blind Phase I study is being conducted by the Centre for Human Drug Research (CHDR), a
world-class institute in Leiden, the Netherlands, specializing in cutting-edge early-stage clinical drug research. The study aims to enrol 49 healthy volunteers, to assess safety, pharmacokinetics (PK) and pharmacodynamics (PD).
CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model allowing for the evaluation of IMP761 s pharmacodynamic activity at the
earliest stages of clinical development. Immutep anticipates the first safety data from the Phase I study to be available before end of the year with assessment of PK/PD relationships to follow in the first half of CY2025.
The immune checkpoint LAG-3 has been identified as a promising target for agonist
LAG-3 immunotherapy to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among other autoimmune diseases.1,2,3 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
IMP761, a first-in-class immunosuppressive 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.
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:
Catherine Strong, Morrow
+61 (0)406 759 268; c.strong@morrowsodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor
Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
1. Pedersen, J.M., Hansen, A.S., Skej , C. et al. Lymphocyte activation gene 3 is increased and affects cytokine production in rheumatoid arthritis.
Arthritis Res Ther 25, 97 (2023). https://doi.org/10.1186/s13075-023-03073-z
2. Jones BE, Maerz MD et al. Fewer LAG-3+ T Cells in Relapsing-Remitting Multiple Sclerosis and Type 1 Diabetes. J
Immunol. 2022 Feb 1;208(3):594-602. doi: 10.4049/jimmunol.2100850. Epub 2022 Jan 12. PMID: 35022272; PMCID: PMC8820445.
3. Zhou X, Gu Y et al. From bench to bedside: targeting lymphocyte activation gene 3 as a therapeutic strategy for autoimmune diseases. Inflamm Res. 2023
Jun;72(6):1215-1235. doi: 10.1007/s00011-023-01742-y. Epub 2023 Jun 14. PMID: 37314518.
4. Mathieu Angin, Chrystelle Brignone, Fr d ric Triebel; A LAG-3 Specific Agonist Antibody for
the Treatment of T Cell Induced Autoimmune Diseases. J Immunol 15 February 2020; 204 (4): 810 818. https://doi.org/10.4049/jimmunol.1900823
5. Sag, E., Demir, S., Aspari, M. et al. Juvenile idiopathic arthritis: lymphocyte activation gene-3 is a central
immune receptor in children with oligoarticular subtypes. Pediatr Res 90, 744 751 (2021).
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