Immutep Announces First-in-Human Phase I Study of IMP761 Progresses to Dose Escalation Portion of Trial

Media Release

First safety data anticipated before year end with assessment of PK/PD relationships to follow in H1’CY2025

SYDNEY, AUSTRALIA, Oct. 17, 2024 (GLOBE NEWSWIRE) -- (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 part (Part A, single dose) of the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761 has been fully recruited and the drug has been administered with no safety issues.

The trial being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, has now progressed to the Part B dose escalation phase with single IMP761 dosing planned to move from 0.03 mg/kg up to 0.90 mg/kg. Both safety and pharmacokinetic/pharmacodynamic (PK/PD) modeling will be assessed in this second cohort of healthy volunteers (N=30). Pending no safety issues, the trial will then shift to the multiple ascending dose portion (Part C) in 14 subjects in which PK will be further evaluated.

CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model in Parts B and C of this Phase I study, allowing for the evaluation of IMP761’s pharmacodynamic activity at this early stage of clinical development.

Immutep anticipates the first safety data from the trial to be available before year end with assessment of PK/PD relationships to follow in the first half of CY2025. For more information on the trial, please visit clinicaltrials.gov (NCT06637865).

About IMP761

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 , 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  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.

About Immutep

Immutep 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 .

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