Immutep Limited reported that its first‑in‑human, placebo‑controlled Phase I study of the LAG‑3 agonist antibody IMP761 has completed the 2.5 mg/kg and 7 mg/kg dose cohorts in healthy volunteers, with no treatment‑related adverse reactions beyond mild intensity.
The study confirmed dose‑dependent immunosuppression, showing significant, long‑lasting inhibition of T‑cell‑mediated intradermal reactions to a strong foreign antigen at days 2, 9 and 23. The pharmacokinetic‑pharmacodynamic analysis established a clear relationship between dose and effect, supporting the hypothesis that IMP761 can silence dysregulated T cells in autoimmune disease settings.
Dr. Frédéric Triebel, Chief Scientific Officer, highlighted that the long‑lasting immunosuppressive effect and the robust PK/PD curve provide a strong proof‑of‑concept for treating conditions such as rheumatoid arthritis, type 1 diabetes and multiple sclerosis. The data reinforce Immutep’s strategy to expand its LAG‑3 platform beyond oncology into the high‑potential autoimmune market.
Immutep’s FY 2025 financials show a net loss of A$61.4 million, up from A$42.7 million in FY 2024, and revenue of A$10.33 million, a rise from A$7.84 million. The company maintains a solid cash position that supports continued investment in its pipeline, including the ongoing Phase III program for eftilagimod alfa in non‑small cell lung cancer.
The company plans to release additional Phase I data in the first half of 2026 and expects to present the findings at a major autoimmune conference. The successful completion of the higher‑dose cohorts positions IMP761 as a promising candidate for future clinical development and underscores Immutep’s commitment to advancing its LAG‑3 therapeutics.
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