Immutep Limited

SYDNEY, AUSTRALIA, July 29, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces 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.

Immutep CMO, Stephan Winckels M.D., Ph.D, said, “Our engagement to date with physicians in the lung cancer community, including at ELCC in Paris and ASCO in Chicago, has yielded encouraging feedback with a shared view of efti as a safe, easy-to-administer immunotherapy with strong efficacy across two 1L NSCLC trials. We look forward to continuing our investigator discussions at WCLC and ESMO around the pivotal TACTI-004 Phase III, which has the potential to change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression.”

Details for the poster presentation:
Title: TACTI-004, a Phase 3 trial of Eftilagimod Alfa plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1st line NSCLC 
Presenter: Dr. Martin Sebastian, University Hospital of Frankfurt, Germany
Session: Clinical Trials in Progress
Date and Time: Tuesday, 9 September 2025 at 10:00 AM CEST

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

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-ƴ 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 carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 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).

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About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. 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. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; [email protected]

U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; [email protected]

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