Immutep Provides Positive Update on Phase I Study of IMP761, a First-in-Class LAG-3 Agonist Antibody
On December 22, 2025, Immutep Limited (NASDAQ: IMMP), a leading late-stage immunotherapy company focused on cancer and autoimmune diseases, announced promising results from the first-in-human Phase I clinical study of IMP761, a pioneering LAG-3 agonist antibody. The study has successfully progressed beyond the single-ascending dose portion, specifically at the 2.5 mg/kg and 7 mg/kg dosing levels.
Key Study Findings
The Phase I clinical trial, which is placebo-controlled and double-blind, showed that IMP761 has been well tolerated, with no significant treatment-related adverse effects observed. The outcomes include:
- Successful completion of the 2.5 mg/kg and 7 mg/kg dosing levels.
- Observed dose-dependent immunosuppressive effects against a strong foreign antigen.
- Significant and prolonged inhibition of T-cell-mediated responses at multiple time points.
Specifically, the trial recorded marked long-lasting inhibition of T-cell reactions at days 2, 9, and 23 after administration.
Dr. Frédéric Triebel’s Insights
Dr. Frédéric Triebel, Chief Scientific Officer of Immutep, expressed enthusiasm regarding the findings: “We are excited to see IMP761 having a long-term immunosuppressive effect after a single injection. A solid pharmacokinetic/pharmacodynamic relationship has now been established between 1 and 7 mg/kg with eight participants per group to cover the variability of the responses.” He further emphasized that the substantial immune suppression seen with IMP761 highlights its potential efficacy in addressing autoimmune disorders associated with dysregulated T cells.
Potential Impact on Autoimmune Diseases
The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has emerged as a significant target for treating various autoimmune diseases, including rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis—each representing multi-billion dollar markets. IMP761 is the first LAG-3 agonist antibody specifically designed to mitigate these prevalent disorders.
By enhancing the inhibitory function of LAG-3, IMP761 aims to silence memory T cells that cause autoimmune responses, restoring balance in the immune system while potentially minimizing side effects compared to existing treatments.
Next Steps for Immutep
With the encouraging safety and efficacy data available thus far, Immutep is committed to advancing the trial as planned. The company anticipates further updates in the first half of CY2026, including possible presentations of data during major medical conferences focused on autoimmune diseases.
About IMP761
IMP761 represents a cutting-edge approach to treating autoimmune conditions through the selective suppression of pathogenic T cells. Preclinical findings published in the Journal of Immunology indicated that IMP761 effectively inhibits T cell proliferation and activation. Notably, further research has highlighted its potential benefits in treating conditions such as oligoarticular juvenile idiopathic arthritis (o-JIA).
About Immutep
Immutep is a late-stage biotechnology company dedicated to developing novel immunotherapies targeting cancer and autoimmune diseases. Spearheading advancements related to Lymphocyte Activation Gene-3 (LAG-3), Immutep aims to harness its expertise to deliver innovative treatments while maximizing shareholder value. For additional information, please visit www.immutep.com.