The registrational TACTI-004 trial in first line non-small cell lung cancer (1L NSCLC) has enrolled 378 patients globally, 50% of the trial's targeted enrolment Futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively SYDNEY, AUSTRALIA, Feb. 06, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announ ...

Media Release Entered into strategic collaboration with Dr. Reddy’s for commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater ChinaIn January 2026, Immutep received ~A$30 million upfront payment from Dr. Reddy’s and is eligible to receive up to ~A$528 million in potential milestones, plus royalties on commercial sales of eftiStrong operational progress reported for TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in first line non-small cell l ...

Core Insights - Immutep Limited announced positive results from a Phase I study of IMP761, a first-in-class LAG-3 agonist antibody targeting autoimmune diseases [1][2][3] Study Results - The trial successfully completed the single-ascending dose escalation at 2.5 and 7 mg/kg, showing positive safety and efficacy data with no significant adverse reactions [2][7] - Evidence of dose-dependent immunosuppressive effects was observed, with significant inhibition of T-cell-mediated reactions at multiple time points [2][3][7] Mechanism and Target - IMP761 enhances the "brake" function of LAG-3 to silence dysregulated T cells, potentially addressing the root causes of autoimmune diseases [4][6] - The LAG-3 immune checkpoint is a promising target for conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, which represent multi-billion dollar markets [3][4] Future Developments - The trial will continue as planned, with further updates expected in the first half of CY2026, including potential presentations at major medical conferences [5][7] 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 [9]

Core Insights - Immutep Limited reports significant operational progress in the TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer [1][5] Group 1: Trial Progress - The TACTI-004 trial has enrolled 289 patients, which is over 38% of the targeted 756 patients, with recruitment continuing at a strong pace [2][8] - More than 120 clinical sites have been activated across 27 countries, all of which have received full regulatory approvals [2][8] - The first clinical site in the United States has received regulatory clearance following the FDA's Project Optimus initiative [3] Group 2: Future Milestones - The trial has already enrolled the necessary 170 patients for a futility analysis, which is expected to be conducted in the first quarter of CY2026 [4] - Completion of patient enrollment is anticipated in the third quarter of CY2026 [4] Group 3: Efti Overview - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to initiate a broad anti-cancer immune response [7] - Efti is being evaluated for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer [8][9] 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 therapeutics [10]

Company Overview - Immutep Limited (NASDAQ:IMMP) is a biotechnology company focused on developing therapies for cancer and autoimmune diseases [2]. Recent Developments - The company recently entered into an agreement with Dr. Reddy's Laboratories Ltd.'s subsidiary to develop and commercialize its Eftilagimod Alfa drug outside of North America, Europe, Japan, and Greater China [2]. - Immutep will retain manufacturing rights for Eftilagimod Alfa and will receive a $20 million upfront payment from Dr. Reddy [2]. Clinical Trials and Efficacy - Positive results from phase one and phase two studies were reported, with the phase two study showing efficacy in patients with soft tissue sarcoma when combined with radiotherapy and Merck's Keytruda [4]. - The phase one study demonstrated an 81% survival rate over 24 months for metastatic non-squamous non-small cell lung cancer when Eftilagimod Alfa was used as a first-line treatment in combination with Keytruda and chemotherapy [4].

Core Insights - Immutep Limited (NASDAQ:IMMP) is recognized as a promising micro-cap stock by analysts [1] - The company reported positive results from clinical trials for its drug candidate eftilagimod alpha (efti), showing significant efficacy in treating soft tissue sarcoma and a high overall survival rate for lung cancer patients [2] - A Phase III trial for efti as a first-line treatment for advanced non-small cell lung cancer has successfully enrolled over 170 patients, surpassing the necessary amount for futility analysis [3] Company Overview - Immutep Limited is a biotechnology firm focused on developing novel immunotherapies related to Lymphocyte Activation Gene-3 for cancer and autoimmune diseases, based in Australia [4]

Core Viewpoint - Immutep Limited and Dr. Reddy's Laboratories have entered into a strategic collaboration and exclusive licensing agreement for the development and commercialization of Eftilagimod Alfa (efti) outside of North America, Europe, Japan, and Greater China, marking a significant milestone for both companies [1][6]. Group 1: Collaboration Details - The agreement allows Immutep to retain global manufacturing rights for efti and supply the product to Dr. Reddy's in the licensed markets while keeping all rights in key pharmaceutical markets [3][6]. - Immutep will receive an upfront payment of USD 20 million (approximately AUD 30.2 million) and is eligible for potential regulatory development and commercial milestone payments of up to USD 349.5 million (approximately AUD 528.4 million), along with double-digit royalties on commercial sales [4][8]. Group 2: Product Information - Eftilagimod Alfa is a first-in-class immunotherapy that activates the immune system to combat cancer, currently under evaluation in a Phase III trial for advanced or metastatic non-small cell lung cancer (NSCLC) and other indications such as head and neck cancer, breast cancer, and soft tissue sarcoma [2][8]. - The product has received Fast Track designation from the FDA for first-line treatment in both HNSCC and NSCLC, indicating its potential as a new standard of care in combination therapies [9]. Group 3: Strategic Importance - The collaboration is seen as a way to leverage Dr. Reddy's market access and expertise to maximize the impact of efti, aiming to serve a large patient population globally [5][6]. - This partnership allows Immutep to capture significant value in the licensed markets while maintaining a strong position for future value creation in key markets [6].

Core Insights - Indian drugmaker Dr Reddy's has entered into an exclusive licensing agreement with Australia's Immutep for the manufacturing, development, and distribution of Immutep's cancer therapy [1] Company Summary - Dr Reddy's will be responsible for the manufacturing and distribution of the cancer therapy developed by Immutep, indicating a strategic move to expand its oncology portfolio [1] - The partnership highlights Dr Reddy's commitment to enhancing its capabilities in the oncology sector, which is a growing area in the pharmaceutical industry [1] Industry Summary - The collaboration between Dr Reddy's and Immutep reflects the increasing trend of partnerships in the pharmaceutical industry aimed at accelerating the development of innovative cancer therapies [1] - This licensing agreement may position Dr Reddy's favorably in the competitive oncology market, which is characterized by high demand for effective cancer treatments [1]

Core Insights - Immutep Limited is set to present new data from the AIPAC-003 trial at the 2025 San Antonio Breast Cancer Symposium, highlighting its late-stage immunotherapy targeting cancer and autoimmune diseases [1] Study Overview - The Phase II AIPAC-003 trial involved 66 female participants with HR+ and HER2-negative/HER2-low metastatic breast cancer resistant to endocrine therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1 therapy [2] - Participants were randomized to receive either 30 mg or 90 mg of eftilagimod alfa in combination with paclitaxel to determine the optimal biological dose [2] Efficacy Results - The study reported strong objective response rates (ORR) of 41.9% for the 30 mg dose and 48.5% for the 90 mg dose, with disease control rates (DCR) of 87.1% and 78.8%, respectively [3] - Time to onset of response was similar at 2.0 months for the 30 mg dose and 1.9 months for the 90 mg dose [3] Pharmacodynamic Response - Both dosing levels showed significant increases in immune activation biomarkers, including absolute-lymphocyte count and interferon-gamma, aligning with the mechanism of action of eftilagimod alfa [4] Clinical Implications - The study's findings support the selection of 30 mg as the optimal biological dose, which is crucial for meeting FDA's Project Optimus requirements and advancing Immutep's oncology pipeline [6] - The ongoing Phase III TACTI-004 trial will evaluate eftilagimod alfa in combination with KEYTRUDA and chemotherapy for advanced or metastatic non-small cell lung cancer [6] Presentation Details - The presentation at SABCS 2025 will be led by Dr. Nuhad Ibrahim and will focus on the optimal biological dose of eftilagimod alfa in metastatic breast cancer patients [7][8]

Financial Data and Key Metrics Changes - The company ended the financial year 2025 with a cash and term deposit balance of AUD 129.7 million, providing a cash runway through to the end of calendar year 2026, indicating strong financial management [12][31] - The latest figures for cash and cash equivalents at the end of September 2025 were close to AUD 110 million, reflecting a solid balance sheet [31] Business Line Data and Key Metrics Changes - The lead immuno-oncology candidate, eftilagimod alpha (EFTI), advanced into the TACTI-004 KEYNOTE F59/1 phase III trial in first-line non-small cell lung cancer, with over 170 patients enrolled, surpassing the number needed for a futility analysis [6][40] - The INCITE-003 trial showed a high 62.7% objective response rate and a 90.2% disease control rate across all PD-L1 expression levels, particularly impressive in patients with PD-L1 expression below 50% [9] Market Data and Key Metrics Changes - The company was added to the S&P/ASX 300 Index in September 2024, indicating increased investor confidence and visibility in the market [12][58] - The company continues to face challenges from supply chain disruptions and geopolitical instability, affecting market access and investment flows [13] Company Strategy and Development Direction - The company aims to maintain its leadership in LAG-3 immunotherapy, focusing on clinical trials for EFTI in oncology and autoimmune diseases [5][11] - The strategic collaboration with Merck for the TACTI-004 trial is a critical component of the company's strategy to address high unmet medical needs in first-line non-small cell lung cancer [30][34] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the complex challenges in the biotechnology sector but expressed confidence in navigating these hurdles through strong clinical data and operational skills [12][13] - The company anticipates continued momentum in clinical trials and updates on various studies, including TACTI-004 and APEX-003, in the upcoming financial year [14][59] Other Important Information - The company received positive feedback from the FDA regarding the late-stage clinical development of EFTI in head and neck squamous cell carcinoma patients with low PD-L1 expression [8] - The first-in-human phase I trial of IMP761 showed a promising 80% reduction in T cell activity, supporting its potential in autoimmune diseases [11] Q&A Session Summary Question: Are there copies of the annual report here? - Yes, copies of the annual report are available [16] Question: Any other questions regarding the financial and other reports? - No further questions were submitted regarding the financial and other reports [60]