Board Change • May 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 5 highly experienced directors. Independent Non-Executive Director Lis Boyce was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Mar 19
Immutep Limited Reports Progress From Phase I Study Of LAG-3 Agonist IMP761 For Autoimmune Diseases Immutep Limited reported that the single ascending dose (SAD) portion of its IMP761 study has been successfully completed, with dosing up to 14 mg/kg. IMP761 was well tolerated across all dose levels, and no safety concerns or dose-limiting toxicities were observed to date. The study is currently progressing in the multiple ascending dose (MAD) portion, which is evaluating pharmacokinetics and safety across two dose levels. Completion of the MAD portion is expected in the third quarter of 2026. IMP761 continues to show a clear immunosuppressive effect in healthy participants challenged with a foreign antigen in an intra-dermal reaction, with durable inhibition of T-cell–mediated responses after a single administration. These 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. IMP761 data, including Phase I results, will be presented at the European Alliance of Associations for Rheumatology (EULAR) annual congress in London, UK on 4th June 2026 at 1.30 pm UK time in a poster view session. A LAG-3 agonist represents a novel therapeutic approach aimed at restoring immune tolerance by modulating T-cell activity, with potential applications across a range of autoimmune diseases, including rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis. IMP761 is the first LAG-3 agonist antibody developed to potentially treat these large, increasingly prevalent disorders, each of which represent multi-billion-dollar markets. By enhancing the physiological “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells, IMP761 is designed to target the cause of autoimmune diseases and restore balance to the immune system. LAG-3 expression on activated T cells demonstrates high specificity for disease sites, especially in tissues characterised by chronic inflammation. This distinct characteristic of the LAG-3 immune checkpoint suggests IMP761 may enable a more targeted therapeutic approach with fewer adverse effects compared to other treatments. IMP761, a first-in-class immunosuppressive lymphocyte-activation gene-3 (LAG-3) agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. Encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile idiopathic arthritis details how IMP761 led to a decrease in 48 hours in a broad spectrum of effector cytokines in coculture experiments where patients T cells are mixed with autologous synoviocytes. Similarly, IMP761 decreased IFN?, interleukin-4, and tumor necrosis factor a levels in supernatants from cocultures of T cells from patients with systemic sclerosis with their autologous dermal fibroblasts. Announcement • Mar 13
Immutep Limited Discontinues TACTI-004 Phase III Study in First Line NSCLC Following Futility Analysis Immutep Limited announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating eftilagimod alfa (efti) in patients in first line non-small cell lung cancer has recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol. Based on its review of the available safety and efficacy data, the IDMC recommended that the trial be discontinued for futility. In response to the IDMC’s recommendation, enrolment in the study will be halted and the Company will implement an orderly wind down of the study, including appropriate patient follow up and site close out in accordance with regulatory and ethical obligations. Immutep now anticipates its cash runway will be extended well beyond the previously guided timeframe of Second Quarter calendar year 2027, which was set prior to the trial's cessation. The Company will provide an updated outlook on its revised cash runway and will reassess capital allocation priorities once operational assessments and a full analysis of the study data have been finalised. TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial was to enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients were being randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints were progression-free survival and overall survival. Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile has enabled various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). 
