Immutep Limited (ASX:IMM) has entered into an agreement with the Centre for Human Drug Research (CHDR) in the Netherlands to perform a first-in-human clinical study of IMP761.
This LAG-3 agonist antibody has been designed to restore balance to the immune system and address the underlying cause of many autoimmune diseases.
The company said subject to the relevant ethical and regulatory approvals, the single and multiple ascending doses, placebo-controlled, double-blind, Phase 1 study would enrol approximately 49 healthy volunteers, to assess safety, pharmacokinetics and pharmacodynamics.
The study will implement CHDR's 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, Dr Frédéric Triebel, said, "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."
Dr Matthijs Moerland, research director of immunology and principal Investigator for the 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."
