Posted: 19 April 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 it has entered into an agreement with the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761. This proprietary LAG-3 agonist antibody has been designed to restore balance to the immune system and address the underlying cause of many autoimmune diseases.
Subject to the relevant ethic and regulatory approvals, the single and multiple ascending dose, placebo-controlled, double-blind, Phase I study will enrol approximately 49 healthy volunteers, with the objective of assessing safety, pharmacokinetics (PK) and pharmacodynamics (PD). The study will implement CHDR’s unique keyhole limpet haemocyanin (KLH) challenge model that allows for the evaluation of immunomodulatory agents’ pharmacological activity at the earliest stages of clinical development.
Immutep’s Chief Scientific Officer, Frédéric Triebel, M.D., Ph.D., stated, “IMP761 is a first-in-class LAG-3 agonist antibody developed to reinforce the dampening of T cell responses in autoimmunity. The phase I trial in healthy subjects is designed to establish clear PK/PD relationships at different dose levels, with a placebo control group, to lay the foundation for the future development of this novel immunotherapy. We are excited to leverage CHDR’s expertise in working with targeted immunotherapy candidates in the clinical setting to evaluate IMP761’s potential in changing how autoimmune disorders are treated.”
Matthijs Moerland, Ph.D., CHDR’s Research Director Immunology and Principal Investigator for the upcoming trial, said, “It is an honour for us to run the first clinical study with IMP761. We’re very excited to be partnering with Immutep for this critical step in the development plan of their promising antibody. We are confident that CHDR’s unique neoantigen KLH challenge model will help define and measure by dose levels its pharmacological activity in man.”
Immune checkpoint agonists, including LAG-3, PD-1, and CTLA-4, are increasingly gaining recognition in the healthcare industry for their inherent ability to treat autoimmune diseases.1 In numerous scientific publications, LAG-3 has been identified as a promising target for agonist immunotherapy for autoimmune disorders including rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among others.2,3,4
IMP761 is uniquely positioned as the world’s first immunosuppressive LAG-3 agonist antibody. It may address numerous autoimmune diseases by silencing self-antigen-specific memory T cells, which accumulate at disease sites, and preventing their overactivation. This is accomplished through enhancing LAG-3’s natural downregulation of auto-reactive memory T cells. IMP761 remains on target to enter the clinic mid-CY2024 and Immutep looks forward to providing more information as it approaches this important milestone.
