Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP761

Media Release

• Centre for Human Drug Research (CHDR) will conduct Phase I trial to evaluate IMP761, a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system and address the underlying cause of autoimmune diseases
• CHDR will utilize its unique challenge model that enables insights into IMP761’s pharmacological activity early in clinical development
• Trial expected to begin mid-CY2024
  
  

SYDNEY, AUSTRALIA, April 18, 2024 (GLOBE NEWSWIRE) -- 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.”