Single-ascending dose portion of study has successfully completed 2.5 and 7 mg / kg levelsDose dependent immunosuppressive effect against a strong foreign antigen observed with continued favourable safety profileSubstantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseasesGiven encouraging efficacy and safety, the trial will continue as planned and further updates are anticipated in 1H CY2026 including presentation of data at a major medical conference ...

The registrational TACTI-004 Phase III has enrolled 289 patients globally, over 38% of the trial’s targeted enrolmentStrong operational progress continues globally with over 120 activated clinical sites and 27 countries having received full regulatory approvals including the United States Futility analysis remains on track for the first quarter of CY2026 and completion of patient enrolment in the third quarter of CY2026 SYDNEY, AUSTRALIA, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: ...

We recently published 7 Best ASX Stocks to Buy Right Now.  Immutep Limited (NASDAQ:IMMP) is one of the best ASX stocks. Immutep Limited (NASDAQ:IMMP) is a biotechnology company developing therapies for cancer and autoimmune diseases. The firm’s shares underwent notable traction earlier this week after Indian firm Dr. Reddy’s Laboratories Ltd.’s subsidiary entered into an agreement with its subsidiary to develop and commercialize a drug outside countries in North America, Europe, Japan, and Greater China. ...

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]

Dr. Reddy’s receives exclusive rights to develop and commercialise Eftilagimod Alfa in all countries outside North America, Europe, Japan, and Greater China Under the terms, Immutep to receive upfront payment of USD 20 million (~AUD 30.2 million) and is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus double-digit royalties on commercial sales Sydney, Australia/Hyderabad, India, Dec. 08, 2025 (GLOBE NEWSWIRE) - ...

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]

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 [12] - Cash and cash equivalents at the end of September 2025 were close to AUD 110 million, indicating strong cash reserves for research and development [31] Business Line Data and Key Metrics Changes - The lead immuno-oncology candidate, eftilagimod alpha (efti), advanced into the TACTI-004 KEYNOTE F9/1 phase III trial in first-line non-small cell lung cancer, with over 170 patients enrolled [6][36] - The multicenter INSIGHT-003 trial showed a high 62.7% objective response rate and 90.2% disease control rate across all PD-L1 expression levels [9] - The phase II AIPAC-003 trial in metastatic breast cancer completed enrollment, with updates expected at the San Antonio Breast Cancer Symposium in December 2025 [10] Market Data and Key Metrics Changes - The company was added to the S&P/ASX 300 Index in September 2024, reflecting investor confidence in its growth trajectory [12] - The company is conducting trials in 24 countries, with over 100 clinical sites open for enrollment [7][40] Company Strategy and Development Direction - The company aims to develop and commercialize innovative immunotherapies targeting cancer and autoimmune diseases, with a focus on eftilagimod in combination with KEYTRUDA and chemotherapy [14][30] - The strategy includes navigating challenges in the biotechnology sector, such as supply chain disruptions and geopolitical instability, while maintaining a focus on clinical trial execution [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the changing global regulatory environment and emphasized the importance of timely execution of clinical trials [12][13] - The company anticipates meaningful progress in financial year 2026, with continued momentum for TACTI-004 and updates from other trials [14] Other Important Information - The company received positive feedback from the FDA regarding the late-stage clinical development of efti for head and neck cancer patients with low PD-L1 expression [8] - The company was granted 17 new patents across 10 territories for both efti and IMP761 during the financial year 2025 [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 questions or comments on the management of the company? - No questions were submitted in advance, and no further questions were raised during the meeting [60]

Financial Data and Key Metrics Changes - The company ended FY 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 [12] - The latest figures for cash and cash equivalents at the end of September 2025 were close to AUD 110 million, indicating a strong balance sheet [25] 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 [6][34] - 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 [9] - The phase II trial for IMP761, a first-in-class LAG-3 agonist antibody, showed an 80% reduction in T cell activity in skin tissue at the highest dose tested [11] Market Data and Key Metrics Changes - The company has opened over 100 clinical sites for enrollment across 24 countries for the TACTI-004 trial [7] - The company was added to the S&P/ASX 300 Index in September 2024, indicating strong investor confidence [12] Company Strategy and Development Direction - The company aims to develop and commercialize innovative immunotherapies targeting cancer and autoimmune diseases, with a focus on executing clinical trials [14] - The collaboration with Merck for the TACTI-004 trial is a strategic move to address high unmet medical needs in oncology [24][28] - The company is navigating challenges in the biotechnology sector, including supply chain disruptions and geopolitical instability, while maintaining a focus on clinical trial execution [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate regulatory challenges and operational hurdles while maintaining strong clinical data [13] - The company anticipates continued momentum in FY 2026 with updates from various clinical trials, including TACTI-004 and APEX-003 [14] - Management highlighted the importance of the upcoming futility analysis for the TACTI-004 trial as a de-risking event [52] Other Important Information - The company received positive feedback from the FDA regarding the late-stage clinical development of EFTI in head and neck cancer patients with low PD-L1 expression [8] - The company was granted 17 new patents across 10 territories for both EFTI and IMP761 during FY 2025 [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 questions from the floor about the remuneration report? - No questions were submitted regarding the remuneration report [17] Question: Are there any questions from the floor about the resolution concerning the reelection of Mr. Pete Myers? - No questions were raised regarding Mr. Myers' reelection [18] Question: Are there any questions from the floor about the resolution concerning performance rights to Mr. Pete Myers? - No questions were submitted regarding this resolution [19] Question: Are there any questions from the floor about the resolution concerning performance rights to Dr. Russell Howard? - No questions were raised regarding Dr. Howard's performance rights [20] Question: Are there any questions or comments on the management of the company? - No questions were submitted in advance of the meeting [53]