Immutep to Present Positive Interim Phase I Data for IMP761, a First-in-Class LAG-3 Agonist Antibody, at EULAR 2026

• First-in-human Phase I study met its primary endpoint, demonstrating favourable safety and tolerability in healthy volunteers in the single ascending dose part of the study
• Phase I data demonstrate statistically significant pharmacodynamic activity at 7 mg/kg in a validated placebo controlled double blinded setting, supporting further clinical investigation in autoimmune diseases
• Additional trial updates will follow in H2 CY2026
  
  

SYDNEY, AUSTRALIA, June 04, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel immunotherapies, today announced it will present first-in-human clinical data for its lead autoimmune candidate, IMP761, at the European Alliance of Associations for Rheumatology (EULAR) Congress, in London, UK on 4th June 2026 at 1.30 pm UK time in a poster session.

The data is from the ongoing Phase I, randomized, placebo-controlled, double-blind first-in-human study (NCT06637865) being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, evaluating IMP761 in healthy volunteers using CHDR’s keyhole limpet haemocyanin (KLH) challenge model. The KLH challenge is a validated human immune response model that enables insights into IMP761’s pharmacological activity early in clinical development.

Initial clinical findings showed significant and clinically relevant pharmacodynamic activity, including reduction of local inflammatory responses and attenuated T-cell activity compared to placebo across cohorts ranging from 0.9 mg/kg to 7 mg/kg, with 7 mg/kg being statistically significantly better in terms of skin blood perfusion compared to placebo (p = 0.029). IMP761 was safe and very well tolerated at all dose levels tested and the study successfully reached its primary endpoint for the single ascending dose part of the study. The pharmacokinetics of single ascending doses of IMP761 support once per 4-week dosing.

The results highlight the potential of IMP761 to treat multiple autoimmune diseases driven by T-cell mediated inflammation and support further evaluation in a Phase II setting.

Dr. Frédéric Triebel, CSO of Immutep commented: “I am very excited about this first clinical evaluation of IMP761. IMP761 is designed to selectively target overactive T cells linked to chronic inflammation and is now showing clear immunosuppressive effects at dose levels above 0.9 mg/kg in this placebo controlled Phase I study. IMP761 could be positioned to address significant unmet need across multiple autoimmune indications such as rheumatoid arthritis or other T cell driven conditions.”

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