Immutep announced that its first‑in‑human, placebo‑controlled, double‑blind Phase I study of the LAG‑3 agonist antibody IMP761 has successfully completed the single‑ascending‑dose portion, with dosing up to 14 mg/kg. The study was conducted in healthy participants and showed that IMP761 was well tolerated at all dose levels, with no safety concerns or dose‑limiting toxicities reported to date.
The company noted that the multiple‑ascending‑dose portion of the trial is now underway and is expected to finish in the third quarter of 2026. This milestone builds on earlier updates released in December 2025 and June 2025, which also highlighted favorable safety data and dose‑escalation progress.
While the IMP761 update is encouraging, it comes against a backdrop of recent negative news. In mid‑March, Immutep announced the discontinuation of its TACTI‑004 Phase III study in non‑small‑cell lung cancer, a decision that had already weighed on investor sentiment. The positive Phase I data therefore represents a key pivot point for the company’s autoimmune pipeline, but may not fully offset the impact of the TACTI‑004 setback.
Dr. Frédéric Triebel, Chief Scientific Officer, said that the first‑in‑human findings “support our mechanistic aim of selectively silencing pathogenic, self‑antigen–specific memory T cells via LAG‑3 agonism and provide the basis for dose levels to be tested in a future phase II trial in patients with autoimmunity.” The data also demonstrate durable inhibition of T‑cell–mediated responses after a single administration, underscoring the therapeutic potential of IMP761.
Analysts and investors are watching the progression of the multiple‑ascending‑dose phase closely, as the results will inform the design of the upcoming Phase II study and the broader positioning of Immutep’s autoimmune portfolio. The company plans to present the full Phase I data at the European Alliance of Associations for Rheumatology (EULAR) congress in London on June 4 2026.
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