Immutep (ASX:IMM), a pioneer in LAG-3 immunotherapy, has reached a milestone in the treatment of autoimmune diseases.
The company announced the completion of the single ascending dose portion of its Phase I study for IMP761, a first-in-class LAG-3 agonist antibody.
The innovative therapy is designed to restore immune tolerance by enhancing the body's natural "brake" on T-cell receptor signaling, effectively silencing the dysregulated memory T cells that drive autoimmune responses.
The placebo-controlled, double-blind study conducted in healthy participants demonstrated that IMP761 was well tolerated at doses reaching 14 mg/kg, with no safety concerns or dose-limiting toxicities reported.
Dr Frédéric Triebel, Immutep’s Chief Scientific Officer, noted a clear and durable immunosuppressive effect following a single administration.
The findings provide a robust mechanistic foundation for the drug’s ability to selectively target pathogenic cells, paving the way for future Phase 2 trials in patients suffering from conditions such as rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.
The study has now transitioned into the multiple ascending dose phase, which will further evaluate pharmacokinetics and safety across two dose levels.
Results from this phase are expected by the third quarter of 2026.