Immutep's Phase I Study Regulatory Clearance

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has received regulatory clearance from the ethics and competent authority in the Netherlands to initiate the first-in-human Phase I study of IMP761. IMP761 is the world's first therapeutic LAG-3 agonist antibody designed to treat autoimmune diseases, with the study expected to enrol first participants during Q3 CY2024.

Executive Commentary on IMP761 Phase I Study

Professor Bent Deleuran, MD, Department of Biomedicine, Aarhus University (DK), stated, 'Immune checkpoint molecules such as LAG-3 play pivotal roles in determining the outcome of antigen activation, and as a result hold significant potential in the treatment of autoimmune diseases.' Dr. Frédéric Triebel, Immutep's CSO, added, 'Blocking LAG-3 with an antagonist antibody in cancer patients unleashes the power of the anti-tumor T cell responses, but also leads to autoimmunity in a fraction of the patients. This has put LAG-3 at the center of autoimmune disorders as a co-inhibitory receptor that downplays the T cell receptor response. Using IMP761, an agonist LAG-3 antibody, to reinforce this physiological upstream control of the T cell response represents a new approach to silence the few aggressive T cells that lead to autoimmune diseases.'

Summary of Immutep's Regulatory Clearance for IMP761 Phase I Study

Immutep has received regulatory clearance to initiate the first-in-human Phase I study of IMP761, the world's first therapeutic LAG-3 agonist antibody designed to treat autoimmune diseases. The study aims to enrol 49 healthy volunteers during Q3 CY2024 to assess safety, pharmacokinetics (PK) and pharmacodynamics (PD). The company anticipates first data being available before the end of the year. IMP761 is positioned uniquely in the treatment landscape for autoimmune diseases, aiming to restore balance to the immune system by enhancing the 'brake' function of LAG-3 to silence unregulated self-antigen-specific memory T cells. Immutep's innovative approach represents a significant milestone in the development of novel autoimmune disease treatments, with the potential to address the root cause of many autoimmune diseases and bring innovative treatment options to patients in need.