Immutep（YP1A）株式概要イミューテップ社（Immutep Limited）は、後期段階のバイオテクノロジー企業で、オーストラリアで癌や自己免疫疾患に対する新規のLAG-3関連免疫療法の開発に従事している。 詳細YP1A ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長2/6過去の実績0/6財務の健全性6/6配当金0/6報酬収益は年間47.02%増加すると予測されています リスク分析German市場と比較して、過去 3 か月間の株価の変動が非常に大きい意味のある時価総額がありません ( €54M )現在は利益が出ておらず、今後3年間で利益が出る見込みはない すべてのリスクチェックを見るYP1A Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€0.39374.7% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-108m54m2016201920222025202620282031Revenue AU$54.4mEarnings AU$9.9mAdvancedSet Fair ValueView all narrativesImmutep Limited 競合他社Genetic AnalysisSymbol: DB:8V8Market cap: €42.7m2investSymbol: XTRA:2INVMarket cap: €62.9mDarwinSymbol: MUN:7V0Market cap: €74.4mFormyconSymbol: XTRA:FYBMarket cap: €354.3m価格と性能株価の高値、安値、推移の概要Immutep過去の株価現在の株価AU$0.3952週高値AU$2.9252週安値AU$0.24ベータ2.361ヶ月の変化-19.26%3ヶ月変化-83.45%1年変化-75.68%3年間の変化-81.06%5年間の変化-90.00%IPOからの変化-93.47%最新ニュースお知らせ • Mar 19Immutep Limited Reports Progress From Phase I Study Of LAG-3 Agonist IMP761 For Autoimmune DiseasesImmutep 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.お知らせ • Mar 13Immutep Limited Discontinues TACTI-004 Phase III Study in First Line NSCLC Following Futility AnalysisImmutep 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).お知らせ • Feb 06Immutep Limited Achieves 50% Enrolment in Global TACTI-004 (KeyNOTE-F91) Phase III Trial in 1L NSCLCImmutep Limited announced it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC). The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy., across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival. The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating efti, a first-in-class MHC Class II agonist, in combination with MSD's ("Merck & Co. Inc. ("Merck & Co. Ltd., Rahway, NJ,USA) anti-PD-1 Therapy, 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. 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") in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).お知らせ • Dec 17Immutep Limited Announces Strong Operational Progress in Global TACTI-004 (KEYNOTE-F91) Phase III and Enrolment Continues At Robust PaceImmutep Limited reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer. The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial's targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals. This includes the United States where the first of multiple clinical sites has received full regulatory approvals following the recent completion of the FDA's Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals. As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy's. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment. KeyTRUDA®? is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. The study's dual primary endpoints are 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).お知らせ • Dec 02Immutep Limited to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer SymposiumImmutep Limited announces new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025. The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative. Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-?). Data cut-off date for efficacy results was 15 September 2025. Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD. The AIPAC-003 trial has resulted in the successful completion of the FDA’s Project Optimus requirements and agreement on 30 mg as efti’s OBD carries strategic importance in ongoing and future clinical programs in oncology. This includes the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression, which is now in the process of opening sites in the United States. Details on the SABCS 2025 presentation are as follows: Title: Optimal biological dose of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003. Presenter: Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Presentation number: PS1-09-16. Abstract number: 315. Date and time: Wednesday, December 10 at 12:30-2:30 p.m. CST.お知らせ • Nov 13Immutep Limited Announces Positive Data from the EFTISARC-NEO TrialImmutep Limited announced positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Pawel Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study's prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hylanization/fibrosis (p(fold change from week 1 through pre-surgery). The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery. The promising tumour hylanization/Fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data) may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients. Disease-free survival and overall survival data are immature at this stage and will be presented in the future. 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PDCTL1 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).最新情報をもっと見るRecent updatesお知らせ • Mar 19Immutep Limited Reports Progress From Phase I Study Of LAG-3 Agonist IMP761 For Autoimmune DiseasesImmutep 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.お知らせ • Mar 13Immutep Limited Discontinues TACTI-004 Phase III Study in First Line NSCLC Following Futility AnalysisImmutep 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).お知らせ • Feb 06Immutep Limited Achieves 50% Enrolment in Global TACTI-004 (KeyNOTE-F91) Phase III Trial in 1L NSCLCImmutep Limited announced it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC). The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy., across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival. The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating efti, a first-in-class MHC Class II agonist, in combination with MSD's ("Merck & Co. Inc. ("Merck & Co. Ltd., Rahway, NJ,USA) anti-PD-1 Therapy, 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. 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") in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).お知らせ • Dec 17Immutep Limited Announces Strong Operational Progress in Global TACTI-004 (KEYNOTE-F91) Phase III and Enrolment Continues At Robust PaceImmutep Limited reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer. The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial's targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals. This includes the United States where the first of multiple clinical sites has received full regulatory approvals following the recent completion of the FDA's Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals. As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy's. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment. KeyTRUDA®? is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. The study's dual primary endpoints are 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).お知らせ • Dec 02Immutep Limited to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer SymposiumImmutep Limited announces new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025. The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative. Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-?). Data cut-off date for efficacy results was 15 September 2025. Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD. The AIPAC-003 trial has resulted in the successful completion of the FDA’s Project Optimus requirements and agreement on 30 mg as efti’s OBD carries strategic importance in ongoing and future clinical programs in oncology. This includes the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression, which is now in the process of opening sites in the United States. Details on the SABCS 2025 presentation are as follows: Title: Optimal biological dose of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003. Presenter: Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Presentation number: PS1-09-16. Abstract number: 315. Date and time: Wednesday, December 10 at 12:30-2:30 p.m. CST.お知らせ • Nov 13Immutep Limited Announces Positive Data from the EFTISARC-NEO TrialImmutep Limited announced positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Pawel Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study's prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hylanization/fibrosis (p(fold change from week 1 through pre-surgery). The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery. The promising tumour hylanization/Fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data) may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients. Disease-free survival and overall survival data are immature at this stage and will be presented in the future. 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PDCTL1 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).お知らせ • Oct 21Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented At ESMO Congress 2025Immutep Limited announced positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001). This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients. These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade =3 toxicity related to immunotherapy.お知らせ • Oct 15Immutep Limited, Annual General Meeting, Nov 27, 2025Immutep Limited, Annual General Meeting, Nov 27, 2025.お知らせ • Oct 14Immutep Limited Announces Successful Completion of FDA Project Optimus RequirementsImmutep Limited announced that positive and straightforward feedback has been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti). The agreement with the FDA on eftilagimod Alfa (efti). The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of this first-in-class immunotherapy, including the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression. With the conclusion of Project Optimus, this registrational study is now in process of opening sites in the United States.お知らせ • Oct 09Immutep Limited Announces Update for Tacti-004 (Keynote-F91) Phase Iii Trial in First Line Non-Small Cell Lung CancerImmutep Limited announced a patient enrolment update for the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) and chemotherapy as first line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC). This registrational Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount necessary to conduct the futility analysis. Additionally, the number of activated clinical trial sites continues to expand at a strong pace and there are now over 100 active clinical sites across 24 countries globally. The futility analysis will be assessed by an independent data monitoring committee (IDMC) based on the data of a predefined number of patients with sufficient follow-up (minimum 12 weeks) and predefined criteria for efficacy. The trial remains on track for the IDMC to conduct the futility analysis in the first quarter of CY2026. The study's dual primary endpoints are 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 in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).お知らせ • Sep 08Immutep Limited Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation At CTOS 2025Immutep Limited announced an abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Bocaaton, Florida. EFTISARC-N NEO is the first study to evaluate eftilagimod alpha (efti) in a neoadjuvant setting (prior to surgery) administered in combination with radiotherapy plus KEYTRUDA®? (pembrolizumab) for patients with soft tissue sarcoma (STS).お知らせ • Aug 05Immutep Limited Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPSImmutep Limited announced it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa ("efti"), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] Based on its review of the encouraging data in 1L HNSCC with CPS ®? (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS Paths for future clinical development and potential accelerated approval in light of the FDA's Project FrontRunner include a randomised registrational trial evaluating efti in combination with KeyTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data. Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients' lives. Patients with CPS 1). All currently available treatment options for patients with PD-L1 CPS. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response.お知らせ • Jul 29Immutep Limited to Present Pivotal TACTI-004 Trial in Progress Poster at the 2025 World Conference on Lung CancerImmutep Limited announced an upcoming poster presentation for the pivotal TACTI-004 (KEYNOTE-F91) Phase III trial at the IASLC 2025 World Conference on Lung Cancer (WCLC), taking place in Barcelona, Spain, from 6-9 September 2025. The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company's antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA®? (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%) and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.お知らせ • Jun 24Immutep Limited Announces Positive Update from Phase I Study of IMP761, A First-In-Class LAG-3 Agonist Antibody for Autoimmune DiseasesImmutep Limited announced positive initial efficacy data and continued favourable safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. Through the highest dosing level to date (0.9 mg/kg of IMP761), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. Given the encouraging efficacy and safety, Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising therapeutic target for rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis in multiple publications.1-3 IMP761 is the first LAG-3 agonist antibodies developed to potentially treat these large and growing disorders, each of which represent multi-billion dollar markets, and many other autoimmune diseases. By enhancing the "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. The Phase I trial is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761's pharmacological activity. Additional data from the Phase I to follow in second half of CY2025.お知らせ • May 27Immutep Limited's Efti with Radiotherapy & KEYTRUDA®? (Pembrolizumab) Meets Primary Endpoint in Phase Ii for Soft Tissue SarcomaImmutep Limited announced the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sar Coma (STS). Tumour hyalinization/fIBrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients. The trial's investigators at the Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization /fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTIS ARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.お知らせ • May 15Immutep Limited's Efti with Keytruda (Pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung CancerImmutep Limited announced that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). Major of Patients have PD-L1 TPS 1: 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%) 64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (PS 1-49%) and 54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression. The trial will assess the safety, tolerability, and initial efficacy of the combination. Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-y and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L1 immunotherapy 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).お知らせ • May 06Immutep Limited's Efti in Combination with KEYTRUDA®? (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPSImmutep Limited announced an excellent median Overall Survival (OS) of 17.6 months has been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the Phase II study evaluates Eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below 1 (Combined Positive Score [CPS] The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches for 1L HNSCC patients withPS 1,2 Patients with CPS 1). Additionally, all available treatment options for patients with PD-L1 CPS 3. Efti has Fast Track designation in 1L HNSCC and Immutep has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps including potential paths to approval for 1L HNSCC with PD-L1 CPS. About Eftilagimod Alfa (efti) Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, Efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-y and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L1 immunotherapy 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).お知らせ • Mar 25Immutep Limited Announces First Patient Dosed in TACTI-004 Phase III Trial in First Line Non-Small Cell Lung CancerImmutep Limited announced the first patient has been successfully dosed in the Company's pivotal TACTI-004 Phase III trial. TACTI-004 will evaluate Immutep's eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first line treatment for patients with advanced or metastatic non- small cell lung cancer (1L NSCLC). Recruitment in TACTI-004 is underway at a growing number of activated clinical sites and countries with approvals from all regulatory authorities continues to expand including Australia, Austria, Belgium, Bulgaria, Canada, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Lithuania, Portugal, Spain, and the United Kingdom. Further regulatory clearances in three additional countries are expected shortly, with the remaining countries anticipated in the weeks and months ahead. Lung cancer is the leading cause of death among all cancer types and the incidence is set to increase to approximately 3 million cases worldwide by 2030. NSCLC is the most common type of lung cancer representing ~80-85% of all diagnoses. The condition is often diagnosed at a late stage, and less than 30% of patients are alive five years after diagnosis. There remains a high unmet need for additional treatment options for people living with NSCLC.お知らせ • Mar 20Immutep Limited to Present Pivotal TACTI-004 Trial in Progress Poster At the European Lung Cancer Congress 2025Immutep Limited announced an upcoming poster presentation for the pivotal TACTI-004 Phase III trial. The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025. The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase II agonist, eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA®? (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Details for the poster presentation: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod Alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C. Presentation number: 131TiP. Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau. Session Date and Time: 26 March 2025, 13:50 CET.お知らせ • Jan 22Immutep Limited Announces Patient Enrolment Complete in the Investigator-Initiated EFTISARC-NEO TrialImmutep Limited announced that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial. EFTISARC-N NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS). The Phase II trial conducted by the Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO) in Poland, the national reference centre for STS in Poland, has reached its enrolment target of 40 patients. Additionally, the treatment has been safe with no grade =3 toxicities related to efti and pembrolizumab. Data updates from EFTISARC-NEO are expected in 2025.お知らせ • Dec 18Immutep Announces Initial Safety Data from First-in-Human Phase I Trial Evaluating IMP761Immutep Limited announced favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. Through the first three of five single ascending dose cohorts in healthy participants, there have been no treatment related adverse events. The trial in up to 49 participants is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761’s pharmacological activity. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025. The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising target for an agonist antibody to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among potentially many other autoimmune diseases. This first-in-class agonist LAG-3 antibody is designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.お知らせ • Dec 16Immutep Limited and Monash University Announce First Publication Detailing How Human LAG-3 Binds to MHC Class IIImmutep Limited announced new findings published in Science Immunology that resolve how human lymphocyte activation gene 3 (LAG-3) binds to its main ligand MHC Class II (MHC-II), also known as HLA Class II (HLA-II) in humans. The publication is the first to show the crystal structure of a human LAG-3/HLA-II complex and provides a better foundation for development of blocking LAG-3 therapeutics, including Immutep's anti-LAG-3 small molecule program. Under the oversight of Professor Jamie Rossjohn FAA FRS, at Monash University's Biomedicine Discovery Institute (BDI), and in collaboration with Immutep, this breakthrough is an exemplar of the importance of industry-academia alliances. The LAG-3 immune control mechanism is the exclusive focus of Immutep across both cancer and autoimmunity and a clinically validated target of deep interest throughout the academic, medical, and industry sectors. The Crystal Structure of the Human LAG-3-HLA-DR1-Peptide Complex publication details how LAG-3 engages two HLA-II molecules. The data in the publication supports efti's (soluble LAG-3) preferential binding to a subset of MHC-II molecules on antigen-presenting cells leading to their activation.お知らせ • Dec 12Immutep Limited Reports Promising New Data in Head and Neck Cancer At ESMO Immuno-Oncology 2024Immutep Limited announced positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This study evaluates eftilagimod alpha (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with negative PD-L1 expression. The new promising data presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024 includes strong overall survival, progression-free survival, and durability. This adds to the high response rates and favourable safety data previously reported on 12 July 2024. Data as of the 31 October 2024 cut-off date in evaluable 1L HNSCC patients (N=31) whose tumours express PD-L1 below 1 (Combined Positive Score [CPS]1); Efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals. This data compares favourably to historical results from anti-PD-1 therapy alone in 1L HNSCC patients with PD-L1 CPS 2-3.お知らせ • Dec 10Immutep Limited Announces Initiation of TACTI-004 Phase III Trial in First Line Non-Small Cell Lung CancerImmutep Limited announced the initiation of the pivotal TACTI-004 Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The receipt of regulatory approval from the Australian Therapeutic Goods Administration to commence the TACTI-004 trial is a significant milestone for Immutep and marks its transformation into a Phase III company. This also represents a key step towards potentially establishing a new standard of care for patients with metastatic NSCLC. Australia represents the first approval by all regulatory authorities including ethics committees and Institutional Review Boards (IRB). The Company also anticipates full approval in the United Kingdom shortly as it has received clearances from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Additional approvals from multiple countries are expected in the weeks and months ahead.株主還元YP1ADE BiotechsDE 市場7D5.9%0.9%3.2%1Y-75.7%-12.2%2.5%株主還元を見る業界別リターン: YP1A過去 1 年間で-12.2 % の収益を上げたGerman Biotechs業界を下回りました。リターン対市場: YP1Aは、過去 1 年間で2.5 % のリターンを上げたGerman市場を下回りました。価格変動Is YP1A's price volatile compared to industry and market?YP1A volatilityYP1A Average Weekly Movement45.2%Biotechs Industry Average Movement8.7%Market Average Movement6.1%10% most volatile stocks in DE Market13.6%10% least volatile stocks in DE Market2.7%安定した株価: YP1Aの株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: YP1Aの 週次ボラティリティ は、過去 1 年間で25%から45%に増加しました。会社概要設立従業員CEO（最高経営責任者ウェブサイト1987n/aMarc Voigtwww.immutep.comイミューテップ社（Immutep Limited）は後期段階のバイオテクノロジー企業で、オーストラリアにおいて癌や自己免疫疾患に対する新規のLAG-3関連免疫療法の開発に従事している。同社の主要製品候補は、可溶性LAG-3lg融合ベースのエフティラギモドα（eftiまたはIMP321）で、各種癌の治療薬として臨床開発中である。同社の製品パイプラインには、1次治療非小細胞肺がん（1L NSCLC）を対象とした第III相臨床試験中のTACTI-004、1次治療頭頸部扁平上皮がん（HNSCC）を対象とした第IIb相臨床試験中のTACTI-003も含まれる；TACTI-002はNSCLCとHNSCCの治療薬として第II相臨床試験中、AIPAC-003は転移性乳がんの治療薬として第II/III相臨床試験中、EFTISARC-NEOは軟部肉腫の治療薬として第II相臨床試験中である。さらに、1L NSCLCおよび固形がんを対象とした第I相試験中のINSIGHT-003、転移性尿路上皮がんを対象とした第I相試験中のINSIGHT-005、自己免疫疾患を対象とした前臨床試験中のIMP761、臨床開発中のIMP731およびIMP701を開発している。さらに、固形がん、血液がん、トリプルネガティブ乳がん、メラノーマを対象とした第II相臨床試験中、トリプルネガティブ乳がんを対象とした第I相臨床試験中のLAG525を開発している。イミューテップ社はメルク社、グラクソ・スミスクライン社、EOCファーマ社、ノバルティス社、ラボラトリー・コーポレーション・オブ・アメリカ・ホールディングス社と提携している。同社は以前Prima BioMed Ltdとして知られていたが、2017年11月にImmutep Limitedに社名を変更した。同社は1987年に法人化され、オーストラリアのシドニーに本社を置いている。もっと見るImmutep Limited 基礎のまとめImmutep の収益と売上を時価総額と比較するとどうか。YP1A 基礎統計学時価総額€54.34m収益（TTM）-€51.57m売上高(TTM)€4.87m11.2xP/Sレシオ-1.1xPER（株価収益率YP1A は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計YP1A 損益計算書（TTM）収益AU$7.92m売上原価AU$82.70m売上総利益-AU$74.78mその他の費用AU$9.14m収益-AU$83.92m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）-0.057グロス・マージン-943.86%純利益率-1,059.19%有利子負債／自己資本比率0%YP1A の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/22 20:24終値2026/05/22 00:00収益2025/12/31年間収益2025/06/30データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Immutep Limited 7 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。14 アナリスト機関Melissa BensonBarrenjoey Markets Pty LimitedThomas WakimBell PotterDylan DupuisB. Riley Securities, Inc.11 その他のアナリストを表示
お知らせ • Mar 19Immutep Limited Reports Progress From Phase I Study Of LAG-3 Agonist IMP761 For Autoimmune DiseasesImmutep 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.
お知らせ • Mar 13Immutep Limited Discontinues TACTI-004 Phase III Study in First Line NSCLC Following Futility AnalysisImmutep 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).
お知らせ • Feb 06Immutep Limited Achieves 50% Enrolment in Global TACTI-004 (KeyNOTE-F91) Phase III Trial in 1L NSCLCImmutep Limited announced it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC). The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy., across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival. The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating efti, a first-in-class MHC Class II agonist, in combination with MSD's ("Merck & Co. Inc. ("Merck & Co. Ltd., Rahway, NJ,USA) anti-PD-1 Therapy, 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. 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") in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).
お知らせ • Dec 17Immutep Limited Announces Strong Operational Progress in Global TACTI-004 (KEYNOTE-F91) Phase III and Enrolment Continues At Robust PaceImmutep Limited reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer. The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial's targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals. This includes the United States where the first of multiple clinical sites has received full regulatory approvals following the recent completion of the FDA's Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals. As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy's. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment. KeyTRUDA®? is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. The study's dual primary endpoints are 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).
お知らせ • Dec 02Immutep Limited to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer SymposiumImmutep Limited announces new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025. The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative. Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-?). Data cut-off date for efficacy results was 15 September 2025. Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD. The AIPAC-003 trial has resulted in the successful completion of the FDA’s Project Optimus requirements and agreement on 30 mg as efti’s OBD carries strategic importance in ongoing and future clinical programs in oncology. This includes the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression, which is now in the process of opening sites in the United States. Details on the SABCS 2025 presentation are as follows: Title: Optimal biological dose of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003. Presenter: Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Presentation number: PS1-09-16. Abstract number: 315. Date and time: Wednesday, December 10 at 12:30-2:30 p.m. CST.
お知らせ • Nov 13Immutep Limited Announces Positive Data from the EFTISARC-NEO TrialImmutep Limited announced positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Pawel Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study's prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hylanization/fibrosis (p(fold change from week 1 through pre-surgery). The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery. The promising tumour hylanization/Fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data) may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients. Disease-free survival and overall survival data are immature at this stage and will be presented in the future. 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PDCTL1 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).
お知らせ • Mar 19Immutep Limited Reports Progress From Phase I Study Of LAG-3 Agonist IMP761 For Autoimmune DiseasesImmutep 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.
お知らせ • Mar 13Immutep Limited Discontinues TACTI-004 Phase III Study in First Line NSCLC Following Futility AnalysisImmutep 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).
お知らせ • Feb 06Immutep Limited Achieves 50% Enrolment in Global TACTI-004 (KeyNOTE-F91) Phase III Trial in 1L NSCLCImmutep Limited announced it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC). The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy., across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival. The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating efti, a first-in-class MHC Class II agonist, in combination with MSD's ("Merck & Co. Inc. ("Merck & Co. Ltd., Rahway, NJ,USA) anti-PD-1 Therapy, 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. 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") in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).
お知らせ • Dec 17Immutep Limited Announces Strong Operational Progress in Global TACTI-004 (KEYNOTE-F91) Phase III and Enrolment Continues At Robust PaceImmutep Limited reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer. The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial's targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals. This includes the United States where the first of multiple clinical sites has received full regulatory approvals following the recent completion of the FDA's Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals. As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy's. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment. KeyTRUDA®? is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. The study's dual primary endpoints are 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).
お知らせ • Dec 02Immutep Limited to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer SymposiumImmutep Limited announces new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025. The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative. Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-?). Data cut-off date for efficacy results was 15 September 2025. Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD. The AIPAC-003 trial has resulted in the successful completion of the FDA’s Project Optimus requirements and agreement on 30 mg as efti’s OBD carries strategic importance in ongoing and future clinical programs in oncology. This includes the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression, which is now in the process of opening sites in the United States. Details on the SABCS 2025 presentation are as follows: Title: Optimal biological dose of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003. Presenter: Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Presentation number: PS1-09-16. Abstract number: 315. Date and time: Wednesday, December 10 at 12:30-2:30 p.m. CST.
お知らせ • Nov 13Immutep Limited Announces Positive Data from the EFTISARC-NEO TrialImmutep Limited announced positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Pawel Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study's prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hylanization/fibrosis (p(fold change from week 1 through pre-surgery). The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery. The promising tumour hylanization/Fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data) may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients. Disease-free survival and overall survival data are immature at this stage and will be presented in the future. 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) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PDCTL1 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).
お知らせ • Oct 21Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented At ESMO Congress 2025Immutep Limited announced positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001). This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients. These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade =3 toxicity related to immunotherapy.
お知らせ • Oct 15Immutep Limited, Annual General Meeting, Nov 27, 2025Immutep Limited, Annual General Meeting, Nov 27, 2025.
お知らせ • Oct 14Immutep Limited Announces Successful Completion of FDA Project Optimus RequirementsImmutep Limited announced that positive and straightforward feedback has been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti). The agreement with the FDA on eftilagimod Alfa (efti). The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of this first-in-class immunotherapy, including the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression. With the conclusion of Project Optimus, this registrational study is now in process of opening sites in the United States.
お知らせ • Oct 09Immutep Limited Announces Update for Tacti-004 (Keynote-F91) Phase Iii Trial in First Line Non-Small Cell Lung CancerImmutep Limited announced a patient enrolment update for the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) and chemotherapy as first line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC). This registrational Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount necessary to conduct the futility analysis. Additionally, the number of activated clinical trial sites continues to expand at a strong pace and there are now over 100 active clinical sites across 24 countries globally. The futility analysis will be assessed by an independent data monitoring committee (IDMC) based on the data of a predefined number of patients with sufficient follow-up (minimum 12 weeks) and predefined criteria for efficacy. The trial remains on track for the IDMC to conduct the futility analysis in the first quarter of CY2026. The study's dual primary endpoints are 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 in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L1 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).
お知らせ • Sep 08Immutep Limited Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation At CTOS 2025Immutep Limited announced an abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Bocaaton, Florida. EFTISARC-N NEO is the first study to evaluate eftilagimod alpha (efti) in a neoadjuvant setting (prior to surgery) administered in combination with radiotherapy plus KEYTRUDA®? (pembrolizumab) for patients with soft tissue sarcoma (STS).
お知らせ • Aug 05Immutep Limited Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPSImmutep Limited announced it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa ("efti"), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] Based on its review of the encouraging data in 1L HNSCC with CPS ®? (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS Paths for future clinical development and potential accelerated approval in light of the FDA's Project FrontRunner include a randomised registrational trial evaluating efti in combination with KeyTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data. Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients' lives. Patients with CPS 1). All currently available treatment options for patients with PD-L1 CPS. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response.
お知らせ • Jul 29Immutep Limited to Present Pivotal TACTI-004 Trial in Progress Poster at the 2025 World Conference on Lung CancerImmutep Limited announced an upcoming poster presentation for the pivotal TACTI-004 (KEYNOTE-F91) Phase III trial at the IASLC 2025 World Conference on Lung Cancer (WCLC), taking place in Barcelona, Spain, from 6-9 September 2025. The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company's antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA®? (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%) and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.
お知らせ • Jun 24Immutep Limited Announces Positive Update from Phase I Study of IMP761, A First-In-Class LAG-3 Agonist Antibody for Autoimmune DiseasesImmutep Limited announced positive initial efficacy data and continued favourable safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. Through the highest dosing level to date (0.9 mg/kg of IMP761), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. Given the encouraging efficacy and safety, Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising therapeutic target for rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis in multiple publications.1-3 IMP761 is the first LAG-3 agonist antibodies developed to potentially treat these large and growing disorders, each of which represent multi-billion dollar markets, and many other autoimmune diseases. By enhancing the "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. The Phase I trial is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761's pharmacological activity. Additional data from the Phase I to follow in second half of CY2025.
お知らせ • May 27Immutep Limited's Efti with Radiotherapy & KEYTRUDA®? (Pembrolizumab) Meets Primary Endpoint in Phase Ii for Soft Tissue SarcomaImmutep Limited announced the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sar Coma (STS). Tumour hyalinization/fIBrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients. The trial's investigators at the Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization /fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTIS ARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.
お知らせ • May 15Immutep Limited's Efti with Keytruda (Pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung CancerImmutep Limited announced that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). Major of Patients have PD-L1 TPS 1: 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%) 64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (PS 1-49%) and 54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression. The trial will assess the safety, tolerability, and initial efficacy of the combination. Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-y and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L1 immunotherapy 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).
お知らせ • May 06Immutep Limited's Efti in Combination with KEYTRUDA®? (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPSImmutep Limited announced an excellent median Overall Survival (OS) of 17.6 months has been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the Phase II study evaluates Eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below 1 (Combined Positive Score [CPS] The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches for 1L HNSCC patients withPS 1,2 Patients with CPS 1). Additionally, all available treatment options for patients with PD-L1 CPS 3. Efti has Fast Track designation in 1L HNSCC and Immutep has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps including potential paths to approval for 1L HNSCC with PD-L1 CPS. About Eftilagimod Alfa (efti) Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, Efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-y and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L1 immunotherapy 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).
お知らせ • Mar 25Immutep Limited Announces First Patient Dosed in TACTI-004 Phase III Trial in First Line Non-Small Cell Lung CancerImmutep Limited announced the first patient has been successfully dosed in the Company's pivotal TACTI-004 Phase III trial. TACTI-004 will evaluate Immutep's eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first line treatment for patients with advanced or metastatic non- small cell lung cancer (1L NSCLC). Recruitment in TACTI-004 is underway at a growing number of activated clinical sites and countries with approvals from all regulatory authorities continues to expand including Australia, Austria, Belgium, Bulgaria, Canada, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Lithuania, Portugal, Spain, and the United Kingdom. Further regulatory clearances in three additional countries are expected shortly, with the remaining countries anticipated in the weeks and months ahead. Lung cancer is the leading cause of death among all cancer types and the incidence is set to increase to approximately 3 million cases worldwide by 2030. NSCLC is the most common type of lung cancer representing ~80-85% of all diagnoses. The condition is often diagnosed at a late stage, and less than 30% of patients are alive five years after diagnosis. There remains a high unmet need for additional treatment options for people living with NSCLC.
お知らせ • Mar 20Immutep Limited to Present Pivotal TACTI-004 Trial in Progress Poster At the European Lung Cancer Congress 2025Immutep Limited announced an upcoming poster presentation for the pivotal TACTI-004 Phase III trial. The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025. The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase II agonist, eftilagimod alfa (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA®? (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Details for the poster presentation: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod Alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C. Presentation number: 131TiP. Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau. Session Date and Time: 26 March 2025, 13:50 CET.
お知らせ • Jan 22Immutep Limited Announces Patient Enrolment Complete in the Investigator-Initiated EFTISARC-NEO TrialImmutep Limited announced that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial. EFTISARC-N NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA®? (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS). The Phase II trial conducted by the Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO) in Poland, the national reference centre for STS in Poland, has reached its enrolment target of 40 patients. Additionally, the treatment has been safe with no grade =3 toxicities related to efti and pembrolizumab. Data updates from EFTISARC-NEO are expected in 2025.
お知らせ • Dec 18Immutep Announces Initial Safety Data from First-in-Human Phase I Trial Evaluating IMP761Immutep Limited announced favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. Through the first three of five single ascending dose cohorts in healthy participants, there have been no treatment related adverse events. The trial in up to 49 participants is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761’s pharmacological activity. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025. The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising target for an agonist antibody to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among potentially many other autoimmune diseases. This first-in-class agonist LAG-3 antibody is designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.
お知らせ • Dec 16Immutep Limited and Monash University Announce First Publication Detailing How Human LAG-3 Binds to MHC Class IIImmutep Limited announced new findings published in Science Immunology that resolve how human lymphocyte activation gene 3 (LAG-3) binds to its main ligand MHC Class II (MHC-II), also known as HLA Class II (HLA-II) in humans. The publication is the first to show the crystal structure of a human LAG-3/HLA-II complex and provides a better foundation for development of blocking LAG-3 therapeutics, including Immutep's anti-LAG-3 small molecule program. Under the oversight of Professor Jamie Rossjohn FAA FRS, at Monash University's Biomedicine Discovery Institute (BDI), and in collaboration with Immutep, this breakthrough is an exemplar of the importance of industry-academia alliances. The LAG-3 immune control mechanism is the exclusive focus of Immutep across both cancer and autoimmunity and a clinically validated target of deep interest throughout the academic, medical, and industry sectors. The Crystal Structure of the Human LAG-3-HLA-DR1-Peptide Complex publication details how LAG-3 engages two HLA-II molecules. The data in the publication supports efti's (soluble LAG-3) preferential binding to a subset of MHC-II molecules on antigen-presenting cells leading to their activation.
お知らせ • Dec 12Immutep Limited Reports Promising New Data in Head and Neck Cancer At ESMO Immuno-Oncology 2024Immutep Limited announced positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This study evaluates eftilagimod alpha (efti) in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with negative PD-L1 expression. The new promising data presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024 includes strong overall survival, progression-free survival, and durability. This adds to the high response rates and favourable safety data previously reported on 12 July 2024. Data as of the 31 October 2024 cut-off date in evaluable 1L HNSCC patients (N=31) whose tumours express PD-L1 below 1 (Combined Positive Score [CPS]1); Efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals. This data compares favourably to historical results from anti-PD-1 therapy alone in 1L HNSCC patients with PD-L1 CPS 2-3.
お知らせ • Dec 10Immutep Limited Announces Initiation of TACTI-004 Phase III Trial in First Line Non-Small Cell Lung CancerImmutep Limited announced the initiation of the pivotal TACTI-004 Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The receipt of regulatory approval from the Australian Therapeutic Goods Administration to commence the TACTI-004 trial is a significant milestone for Immutep and marks its transformation into a Phase III company. This also represents a key step towards potentially establishing a new standard of care for patients with metastatic NSCLC. Australia represents the first approval by all regulatory authorities including ethics committees and Institutional Review Boards (IRB). The Company also anticipates full approval in the United Kingdom shortly as it has received clearances from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Additional approvals from multiple countries are expected in the weeks and months ahead.
