Core Insights - Immutep Limited has received positive feedback from the FDA regarding the clinical development of its MHC Class II agonist, eftilagimod alfa (efti), for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression below 1 [1][2][4] Clinical Development - The FDA acknowledged the potential of efti in combination with Merck's KEYTRUDA (pembrolizumab) for patients with CPS <1, indicating support for further development of this combination therapy [2][4] - Future clinical development paths may include a randomized registrational trial comparing efti with KEYTRUDA against standard-of-care therapy or a smaller single-arm study focusing on safety and response rates, followed by a confirmatory randomized study [3][6] Market Need - Patients with CPS <1 in 1L HNSCC represent a significant unmet medical need, with up to 20% of these patients not benefiting from current anti-PD-1 therapies, which are only approved for those with PD-L1 expression (CPS >1) [7] - Current treatment options for patients with PD-L1 CPS <1 are limited to chemotherapy [7] Company Focus - The primary focus of Immutep remains on the pivotal TACTI-004 Phase III trial evaluating efti as first-line therapy for non-small cell lung cancer, with positive feedback from physicians regarding its progress [5] - The company is considering future collaborative clinical development paths for head and neck cancer based on FDA feedback [4][5] About Immutep - Immutep is a late-stage biotechnology company specializing in immunotherapies for cancer and autoimmune diseases, particularly focusing on Lymphocyte Activation Gene-3 (LAG-3) [8] - The company aims to leverage its expertise to provide innovative treatment options and maximize shareholder value [8]

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

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 ...

Core Insights - Immutep Limited, a late-stage immunotherapy company, announced that three abstracts for clinical trials of its MHC Class II agonist, eftilagimod alfa, have been accepted for presentation at the ESMO Congress 2025 in Berlin, Germany [1][2]. Group 1: Clinical Trials and Presentations - A Proffered Paper oral presentation will detail results from the EFTISARC-NEO Phase II trial in resectable soft tissue sarcoma, scheduled for October 19, 2025 [2]. - Data from the INSIGHT-003 Phase I trial in first-line non-small cell lung cancer (1L NSCLC) will be presented as a poster on October 18, 2025 [2]. - An abstract on the pivotal TACTI-004 Phase III trial in 1L NSCLC has been accepted for a Trials in Progress ePoster presentation [2]. Group 2: Company Overview - Immutep is focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging the LAG-3 pathway to stimulate or suppress immune responses [4]. - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [4].

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

Core Insights - Immutep Limited's investigator-initiated EFTISARC-NEO Phase II trial has successfully met its primary endpoint, demonstrating a significant increase in tumour hyalinization/fibrosis in patients with resectable soft tissue sarcoma (STS) when treated with eftilagimod alfa (efti) combined with radiotherapy and KEYTRUDA® [1][7]. Company Overview - Immutep is a late-stage biotechnology company focused on developing innovative immunotherapies for cancer and autoimmune diseases, particularly leveraging the Lymphocyte Activation Gene-3 (LAG-3) pathway [7]. - The company is pioneering the understanding and advancement of therapeutics related to LAG-3, aiming to provide novel treatment options for patients and maximize shareholder value [7]. Trial Details - The EFTISARC-NEO trial showed a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients, significantly exceeding the prespecified median of 35% [3]. - The trial is primarily funded by a grant from the Polish government, with a total enrollment of 40 patients completed in January 2025 [3][4]. Medical Significance - Tumour hyalinization/fibrosis serves as an early surrogate endpoint linked to improved overall survival and recurrence-free survival in STS patients [2]. - STS is classified as an orphan disease with a high unmet medical need and poor prognosis, with an estimated 13,520 new cases and 5,420 deaths in the U.S. in 2025 [4]. Eftilagimod Alfa (efti) Profile - Efti is a proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [5]. - Efti is under evaluation for various solid tumours, including non-small cell lung cancer and head and neck squamous cell carcinoma, and has received Fast Track designation from the FDA for certain indications [6].

Core Insights - Immutep Limited has reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 trial for its immunotherapy treatment in advanced non-small cell lung cancer [1][7] Group 1: Trial Results - The INSIGHT-003 trial evaluated eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer [1] - The trial showed a significant improvement in overall response rates compared to historical controls, with a 60.8% response rate versus 48.0% in previous registrational trials [4] - In patients with PD-L1 expression below 50%, the response rate was 59.6%, compared to a historical control of 40.8% [5] Group 2: Patient Demographics - Approximately 92% of evaluable patients in the INSIGHT-003 study had PD-L1 Tumor Proportion Score (TPS) below 50%, indicating a high unmet medical need [3][7] - The breakdown of PD-L1 expression levels among evaluable patients included 49% with TPS of 1-49% and 43% with TPS below 1% [3] Group 3: Safety and Future Steps - The safety profile of the triple combination therapy remains favorable, with no new safety signals reported [9] - Additional data updates from the INSIGHT-003 trial are expected to be presented at a medical conference later in 2025 [10] Group 4: Company Background - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [14] - Eftilagimod alpha (efti) is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity for cancer treatment [12]

Group 1 - Immutep Limited (IMMP, PRRUF) is focused on immunotherapy and is pivoting fully into the development of a LAG3 [1] - The company has received an optimistic investment thesis based on its strategic direction in the biotech sector [1] Group 2 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, indicating a strong background in the field [1]

Core Insights - Immutep Limited has reported a median Overall Survival (OS) of 17.6 months in Cohort B of the TACTI-003 Phase IIb trial for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with PD-L1 expression below 1 [1][2] Group 1: Clinical Trial Results - The 17.6-month median OS in evaluable patients (N=31) is significantly better than historical results from standard-of-care treatments, which include 10.7 months from cetuximab + chemotherapy, 11.3 months from anti-PD-1 therapy + chemotherapy, and 7.9 months from anti-PD-1 monotherapy [2] - Efti in combination with pembrolizumab has shown a high overall response rate with multiple complete responses, indicating a promising efficacy profile [4][5] Group 2: Unmet Medical Need - Patients with CPS <1 in 1L HNSCC represent a high unmet medical need, as up to 20% of these patients lack approved immunotherapy-only treatment options [3][6] - The combination of efti and pembrolizumab addresses this gap, as current treatments for this population typically involve chemotherapy [3][6] Group 3: Safety and Regulatory Path - The combination therapy continues to be well-tolerated with no new safety signals reported, reinforcing its potential as a viable treatment option [4] - Immutep has requested a meeting with the U.S. FDA to discuss potential paths to approval for efti in 1L HNSCC with PD-L1 CPS <1, following its Fast Track designation [7][10] Group 4: About Efti - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [8] - The drug is under evaluation for various solid tumors, including non-small cell lung cancer and metastatic breast cancer, highlighting its broad therapeutic potential [9] Group 5: Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [11]

Core Insights - Immutep Limited has successfully dosed the first patient in its pivotal TACTI-004 Phase III trial, evaluating eftilagimod alfa in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer [1][6] Company Overview - Immutep is a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 to stimulate or suppress immune responses [8] Trial Details - TACTI-004 is a randomized, double-blind, controlled Phase III study enrolling approximately 756 patients across over 150 clinical sites in more than 25 countries, targeting advanced or metastatic non-small cell lung cancer without specific genomic aberrations [5][7] - The trial's dual primary endpoints are progression-free survival and overall survival, with recruitment currently underway [7] Market Context - Lung cancer is the leading cause of cancer-related deaths, with an expected increase to approximately 3 million cases globally by 2030, and non-small cell lung cancer (NSCLC) accounts for about 80-85% of all lung cancer diagnoses [3] - There is a significant unmet need for new treatment options in NSCLC, as less than 30% of patients survive five years post-diagnosis [3]