Core Viewpoint - Immutep Limited is advancing its clinical-stage biotechnology programs focused on LAG-3 immunotherapies for cancer and autoimmune diseases, with significant progress in multiple trials and a strong financial position as of June 30, 2025 [2][21]. Oncology Development Program - The TACTI-004 Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with 78 sites across 23 countries activated for patient recruitment [3][4]. - The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy, aiming to randomize approximately 756 patients [4]. - Immutep reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 Phase I trial for non-squamous 1L NSCLC [6]. - In patients with TPS <50%, the triple combination achieved a 59.6% response rate compared to a historical control of 40.8% [7][8]. - The TACTI-003 Phase IIb trial for head and neck cancer showed a median overall survival of 17.6 months, outperforming historical standards of care [9][10]. - The EFTISARC-NEO Phase II trial for soft tissue sarcoma met its primary endpoint, significantly exceeding historical data for tumor hyalinization/fibrosis [12][13]. Autoimmune Disease Development Program - The Phase I trial of IMP761, a LAG-3 agonist antibody, demonstrated significant T cell suppression with a favorable safety profile at a dosing level of 0.9 mg/kg [16][17]. - Initial pharmacodynamic data indicated an 80% reduction in T cell activity, highlighting the potential efficacy of IMP761 in treating autoimmune diseases [18]. Intellectual Property - Immutep was granted four new patents during the quarter, including two for efti in combination with a PD-1 pathway inhibitor and two for IMP761 [19]. Corporate & Financial Summary - The company appointed Stephan Winckels as Chief Medical Officer, bringing over 15 years of oncology drug development experience [20]. - As of June 30, 2025, Immutep reported a cash position of approximately A$129.69 million, exceeding budget expectations [22]. - The net cash used in R&D activities during the quarter was A$15.66 million, reflecting increased clinical trial activities [23].

Core Insights - Immutep Limited announces positive initial efficacy and safety data from the Phase I study of IMP761, a first-in-class LAG-3 agonist antibody targeting autoimmune diseases [1][4][7] - The study shows significant T cell suppression and a favorable safety profile at the highest dosing level of 0.9 mg/kg, with no treatment-related adverse events reported [2][7] - The company plans to continue escalating the dosing levels to 2.5, 7, and 14 mg/kg, with additional data expected in the second half of CY2025 [5][7] Company Overview - Immutep is a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, particularly leveraging the LAG-3 immune checkpoint [3][8] - The company aims to address the root causes of autoimmune diseases by silencing dysregulated memory T cells, potentially offering a more targeted treatment approach with fewer side effects [4][6] Market Potential - The LAG-3 immune checkpoint is identified as a promising target for treating major autoimmune diseases such as rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, which represent multi-billion dollar markets [3][4] - IMP761 has shown encouraging pre-clinical results, indicating its potential to inhibit T cell proliferation and reduce effector cytokines in conditions like oligoarticular juvenile idiopathic arthritis [6]