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Immutep's Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma
GlobeNewswire News Room· 2025-05-27 12:00
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].
Immutep’s Efti with KEYTRUDA® (pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung Cancer
Globenewswire· 2025-05-15 12:00
Marc Voigt, CEO of Immutep, stated, "Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in respons ...
Immutep Limited: Surging On Positive Head And Neck Data
Seeking Alpha· 2025-05-08 12:46
Immutep Limited (IMMP, PRRUF) is an immunotherapy-focused biotech that I've covered recently, coming away with an optimistic take on their investment thesis built on pivoting fully into the development of a LAG3I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of in ...
First Patient Dosed in Immutep’s TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer
Globenewswire· 2025-03-25 12:00
First patient safely dosed at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone for ImmutepGlobal Phase III with efti will enrol approximately 756 patients at more than 150 clinical sitesTrial results will inform potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology SYDNEY, AUSTRALIA, March 25, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy ...
First Patient Dosed in Immutep's TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer
Newsfilter· 2025-03-25 12:00
First patient safely dosed at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone for ImmutepGlobal Phase III with efti will enrol approximately 756 patients at more than 150 clinical sitesTrial results will inform potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology  SYDNEY, AUSTRALIA, March 25, 2025 (GLOBE NEWSWIRE) --  Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy ...
Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the European Lung Cancer Congress 2025
Newsfilter· 2025-03-20 12:00
Core Insights - Immutep Limited is set to present a poster on the pivotal TACTI-004 Phase III trial at the European Lung Cancer Congress (ELCC) 2025, highlighting its focus on immunotherapy for cancer treatment [1][2] Group 1: Trial Overview - The TACTI-004 Phase III trial evaluates Immutep's MHC Class II agonist, eftilagimod alfa (efti), in combination with Merck's anti-PD-1 KEYTRUDA® and chemotherapy for first-line treatment of advanced or metastatic non-small cell lung cancer (1L NSCLC) [2][3] - The global trial aims to enroll approximately 750 patients across over 150 clinical sites in more than 25 countries, regardless of PD-L1 expression [2] Group 2: Presentation Details - The poster presentation is titled "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" [4] - The presentation is scheduled for March 26, 2025, at 13:50 CET, with the poster to be made available on Immutep's website following the event [4] Group 3: 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][6] - Efti is under evaluation for various solid tumors, including NSCLC, head and neck squamous cell carcinoma, and metastatic breast cancer, and has received Fast Track designation from the FDA for first-line treatments in HNSCC and NSCLC [6] 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 Lymphocyte Activation Gene-3 (LAG-3) [7] - The company aims to provide innovative treatment options while maximizing shareholder value [7]
Immutep(IMMP) - 2025 Q2 - Quarterly Report
2025-02-27 11:03
Exhibit 99.1 IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2024 (previous corresponding period: half-year ended 31 December 2023) To be read in conjunction with the 30 June 2024 Annual Report. In compliance with Listing Rule 4.2A. ABN 90 009 237 889 ASX/Media Release (ASX: IMM) 26 February 2025 Appendix 4D Half-Year Financial Report Results for Announcement to the Market Current Reporting Period – Half-year Ended 31 December 2024 Previous Repor ...
Immutep Quarterly Activities Report Q2 FY25
Newsfilter· 2025-01-31 13:00
Core Viewpoint - Immutep Limited has made significant advancements in its clinical programs, particularly with the initiation of the Phase III trial for eftilagimod alfa (efti) in first-line metastatic non-small cell lung cancer (1L NSCLC), marking its transition into a Phase III biotechnology company [3][4][8]. Clinical Development Updates - The TACTI-004 Phase III trial for efti in 1L NSCLC commenced in December 2024, following regulatory approval from the Australian Therapeutic Goods Administration [3][4]. - Positive results from the TACTI-003 (KEYNOTE-C34) Phase IIb trial were reported, showing a 67% 12-month overall survival (OS) rate and a promising progression-free survival (PFS) of 5.8 months for patients with PD-L1 negative tumors [5][6]. - The AIPAC-003 trial in metastatic breast cancer completed patient enrollment in October 2024, with 65 patients randomized to receive different doses of efti in combination with paclitaxel [7][9]. - The INSIGHT-003 trial reported a median OS of 32.9 months and a 24-month OS rate of 81.0% for patients with advanced or metastatic non-squamous NSCLC [10][11][12]. - The EFTISARC-NEO trial demonstrated a greater than three-fold increase in tumor hyalinization compared to historical data, indicating significant efficacy in soft tissue sarcoma [13][14][15]. Product Development and Research - IMP761, a first-in-class agonist LAG-3 antibody for autoimmune diseases, reported favorable initial safety data from its Phase I study [16][17]. - Collaboration with Monash University led to new findings on the binding of LAG-3 to MHC Class II, enhancing the understanding of LAG-3 therapeutics [18]. Intellectual Property - Immutep was granted three new patents for efti and IMP761 in various territories, including Brazil and Japan, enhancing its intellectual property portfolio [19][20]. Financial Overview - As of December 31, 2024, Immutep reported a strong cash position of approximately A$159.26 million, expected to fund operations until the end of CY2026 [23]. - The net cash used in R&D activities during Q2 FY25 was A$16.2 million, reflecting increased clinical trial activities [25]. - Total cash flow used in investing activities for the quarter was A$30.4 million, primarily due to an increase in short-term investments [26].
Immutep Limited: Continuing To Make The Case For Eftilagimod
Seeking Alpha· 2025-01-28 21:37
Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].
Patient Enrolment Completed for EFTISARC-NEO Phase II Trial
Globenewswire· 2025-01-22 13:00
Core Insights - Immutep Limited has completed patient enrolment in the EFTISARC-NEO trial, which evaluates eftilagimod alpha in combination with radiotherapy and KEYTRUDA® for patients with resectable soft tissue sarcoma [1][2][4] Group 1: Trial Details - The Phase II trial, conducted by the Maria Skłodowska-Curie National Research Institute of Oncology, has successfully enrolled 40 patients [2] - Positive data from the trial was presented at the CTOS Annual Meeting in November 2024, showing a greater than three-fold increase in tumour hyalinization/fibrosis (median 50%) compared to a historical median of 15% from radiotherapy alone [3] - The treatment has shown safety with no grade ≥3 toxicities related to efti and pembrolizumab [4] Group 2: Future Expectations - Data updates from the EFTISARC-NEO trial are anticipated in 2025 [4][8]