GW Cancer Center to initiate Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in HR+/HER2-neg breast cancer patientsSecond investigator-initiated trial to evaluate efti in earlier stage disease where its unique activation of a broad anti-cancer immune response may drive optimal benefit and high pathologic response rates SYDNEY, AUSTRALIA, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a ...

Core Insights - Biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and investor conference appearances across several small- and mid-cap companies [1] Company Summaries - **Immutep Ltd. (IMMP)**: Shares rose by 4.37% to $1.67 after-hours, following a decline of 6.98% during regular trading. The stock's rebound was fueled by the acceptance of data from its EFTISARC-NEO Phase II trial for oral presentation at CTOS 2025, focusing on a rare cancer with high unmet need [2][3] - **Nautilus Biotechnology Inc. (NAUT)**: Shares surged by 12.25% to $0.7521 after-hours, recovering from a 4.42% decline in regular trading. The increase was attributed to insider buying by CEO Sujal M. Patel, who purchased 83,500 shares, signaling confidence in the company [4][5] - **Pliant Therapeutics Inc. (PLRX)**: The stock ended regular trading at $1.75, up 1.16%, and jumped 16.00% to $2.03 after-hours. The upcoming third-quarter earnings report on November 6, 2025, is expected to provide updates on its lead candidate targeting idiopathic pulmonary fibrosis [6][7] - **Jin Medical International Ltd. (ZJYL)**: Shares closed at $0.6532, gaining 3.65% during regular trading and rising 7.15% to $0.6999 after-hours. The catalyst for this movement was the announcement of expanded production capabilities in China, aimed at enhancing global delivery of medical equipment [7][8] - **Phio Pharmaceuticals Corp. (PHIO)**: The stock rose 8.20% to $2.64 after-hours, building on a 13.49% increase during regular trading. The momentum was driven by participation in the H.C. Wainwright 27th Annual Global Investment Conference, where updates on its Phase 1b clinical trial for PH-762 will be presented [8][9] - **Kura Oncology Inc. (KURA)**: Shares increased by 6.12% to $8.50 after-hours, following a 1.60% decline in regular trading. The rally was linked to the company's presentation at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for Ziftomenib [10][11][12]

Core Viewpoint - Immutep Limited is set to present findings from the EFTISARC-NEO Phase II trial at the CTOS 2025 Annual Meeting, highlighting the potential of eftilagimod alpha in treating soft tissue sarcoma [1][2]. Group 1: Trial Overview - EFTISARC-NEO is the first study to assess eftilagimod alpha in a neoadjuvant setting, combined with radiotherapy and KEYTRUDA for soft tissue sarcoma patients [2]. - The trial is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, and is primarily funded by a Polish government grant [5]. Group 2: Disease Context - Soft tissue sarcoma (STS) is classified as an orphan disease with significant unmet medical needs and poor patient prognosis [4]. - In the United States, approximately 13,520 new STS cases are expected in 2025, with around 5,420 deaths projected [4]. Group 3: Company Background - Immutep is a late-stage biotechnology company focused on developing innovative immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 [6]. - The company aims to maximize shareholder value while providing new treatment options for patients in need [6].

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]