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: ...

MDNA11 demonstrates durable anti-tumor activity in phase-2 eligible expansion cohorts, enriched for immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H cancers, in each case exceeding objective response rate (ORR) benchmarks in these difficult to treat populations  In the monotherapy expansion cohorts, irrespective of tumor type, patients treated with MDNA11, as the next treatment following progression on immune checkpoint inhibitors (ICI), had an ORR of 42% and a disease control r ...

MDNA11 demonstrates durable anti-tumor activity in phase-2 eligible expansion cohorts, enriched for immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H cancers, in each case exceeding objective response rate (ORR) benchmarks in these difficult to treat populations In the monotherapy expansion cohorts, irrespective of tumor type, patients treated with MDNA11, as the next treatment following progression on immune checkpoint inhibitors (ICI), had an ORR of 42% and a disease control r ...

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]

Core Insights - IO Biotech is focused on developing novel immune-modulatory, off-the-shelf cancer therapies targeting various tumors, including melanoma, lung, and head and neck cancers [2][15] - The IOB-013 study showed improvements in progression-free survival (PFS) but narrowly missed statistical significance on the primary endpoint, which the company believes has de-risked the program [2][5] - The company plans to discuss the next Phase 3 study design for Cylembio with the FDA in December 2025 [2][5] Recent Business Highlights - The company presented topline data from the Phase 3 clinical trial (IOB-013) at the ESMO congress, indicating clinically relevant improvements in PFS across various subgroups [5][6] - A meeting with the FDA is scheduled for December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in advanced melanoma [5][6] - Pre-clinical data for additional candidates targeting arginase 1 and TGF-β were presented at the SITC Annual Meeting [5][6] Financial Results - For Q3 2025, total operating expenses were $19.4 million, down from $26.5 million in Q3 2024 [12][20] - Research and development expenses decreased to $13.7 million from $20.2 million year-over-year [12][20] - Cash and cash equivalents as of September 30, 2025, were approximately $31 million, expected to support operations through Q1 2026 [5][12] Clinical Trials Overview - The IOB-013/KN-D18 trial evaluated Cylembio in combination with Merck's KEYTRUDA in 407 patients with advanced melanoma, with enrollment completed by December 2023 [11][12] - The primary endpoint of the trial was progression-free survival, with secondary endpoints including overall response rate and safety [11][13] - The company is also conducting a Phase 2 basket trial (IOB-022/KN-D38) for advanced non-small cell lung cancer and head and neck cancer [14]

Core Insights - Immutep Limited announced positive results from the EFTISARC-NEO trial, demonstrating significant efficacy in treating resectable soft tissue sarcoma (STS) with a novel combination of eftilagimod alfa (efti), radiotherapy, and KEYTRUDA [1][2] Study Results - The Phase II study showed a median 51.5% tumor hyalinization/fibrosis in the evaluable patient population (N=38), significantly exceeding the prespecified pathologic response rates (p<0.001) [2] - The trial included patients with ten different STS subtypes, including aggressive tumors with poor prognosis such as myxofibrosarcoma (N=16) and undifferentiated pleomorphic sarcoma (N=10) [3] Immune Response - Early data indicated strong immune system activation, with significant increases in key cytokines and chemokines, including CXCL9 (2.5x, p<0.01), CXCL10 (1.8x, p<0.0001), IL-23 (2.2x, p<0.05), and IFN-γ (2.5x, p<0.05) [4][5] - The increase in immune response biomarkers correlated with pathologic responses, suggesting a higher probability of favorable clinical outcomes [5] Clinical Implications - The achieved tumor hyalinization/fibrosis rate is over three times greater than standard-of-care radiotherapy based on historical data, indicating potential for improved overall survival and recurrence-free survival in STS patients [6] - The findings support the hypothesis that efti's activation of antigen-presenting cells enhances both adaptive and innate immunity, which is crucial for effective cancer treatment [7][10] Future Directions - The results suggest that efti may have applications beyond advanced or metastatic cancer, potentially benefiting patients with localized and resectable tumors [10] - Ongoing translational studies aim to further explore the correlation between immune responses and clinical outcomes [6] Recognition - The EFTISARC-NEO trial received the Golden Scalpel Award in Poland, highlighting its innovation and impact in medical research and clinical practice [9][12] Company Overview - 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) [15]

Core Insights - Adagene Inc. has initiated a Phase 2 clinical trial for muzastotug in combination with KEYTRUDA for patients with microsatellite stable colorectal cancer, with the first patient dosed in October 2025 [1][2] - The trial aims to confirm the optimal dosing for a subsequent Phase 3 trial, with completion anticipated in early 2027 and potential updates expected in 2026 [1][2] Phase 2 Clinical Trial Details - The trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, with up to 30 patients per arm [1][4] - The primary endpoint is overall response rate (ORR), while secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [4] Phase 1b/2 Trial Findings - In the Phase 1b/2 trial, 67 patients were treated with muzastotug, showing an ORR of 17% for the 10 mg/kg cohort and 29% for the 20 mg/kg cohort [3][4] - The median duration of response for the 10 mg/kg cohort was 6.2 months, while the median overall survival for the 10 mg/kg cohort was 19.4 months [5] Safety Profile - Muzastotug has been safely dosed at 20 mg/kg with less than 20% Grade 3 adverse events and no discontinuations, indicating a favorable safety profile compared to first-generation anti-CTLA-4 therapies [2][5] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [7][8] - The company's lead program, ADG126 (muzastotug), targets regulatory T cells in the tumor microenvironment and is part of a broader pipeline leveraging its SAFEbody technology [9]

Core Insights - Immutep Limited is focusing on changing the treatment paradigm for first-line non-small cell lung cancer (1L NSCLC) through innovative immunotherapy approaches [1][5]. Clinical Trial Results - The INSIGHT-003 trial demonstrated strong objective response rates (ORR) and disease control rates (DCR) for the combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy in patients with advanced or metastatic non-squamous 1L NSCLC [2][5]. - The ORR for patients with low and no PD-L1 expression (TPS <50%) reached 61.7%, significantly higher than the historical control of 40.8% [3][5]. - The combination therapy showed high ORR and DCR across all PD-L1 expression levels, with specific rates of 54.5% (no PD-L1), 68.0% (low PD-L1), and 75.0% (high PD-L1) [4]. Safety and Efficacy - The combination of efti with KEYTRUDA and chemotherapy has a favorable safety profile and has shown promising clinical responses, particularly in patients with low or absent PD-L1 expression [3][5]. - Efti is expected to set a new standard of care for 1L NSCLC patients, supported by data from multiple clinical trials, including the pivotal TACTI-004 Phase III trial [5][8]. Future Developments - The TACTI-004 Phase III trial is a global study enrolling approximately 756 patients with advanced/metastatic 1L NSCLC, evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003 [5][6]. - Efti is under evaluation for various solid tumors, including head and neck squamous cell carcinoma and breast cancer, and has received Fast Track designation from the FDA for first-line treatments [8]. Company Overview - Immutep is a late-stage biotechnology company specializing in novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [9].

Core Insights - Astellas Pharma and Pfizer announced positive results from the Phase 3 EV-303 clinical trial for PADCEV in combination with KEYTRUDA, showing significant improvements in event-free survival (EFS) and overall survival (OS) for muscle-invasive bladder cancer (MIBC) patients who are ineligible for cisplatin-based chemotherapy [1][2][3] Group 1: Clinical Trial Results - The EV-303 trial demonstrated a 60% reduction in the risk of tumor recurrence, progression, or death for patients treated with PADCEV plus KEYTRUDA compared to surgery alone, with a Hazard Ratio (HR) of 0.40 [2] - The estimated median EFS has not yet been reached for the combination arm, while it was 15.7 months for the surgery alone arm [2] - An estimated 74.7% of patients treated with the combination were event-free at two years, compared to 39.4% for surgery only [2] - The OS results showed a 50% reduction in the risk of death for the combination treatment, with an HR of 0.50 [3] - The estimated median OS has not yet been reached for the combination arm, while it was 41.7 months for the surgery arm [3] - An estimated 79.7% of patients were alive at two years in the combination group, compared to 63.1% for surgery alone [3] Group 2: Safety and Efficacy - The safety profile of the combination treatment was consistent with previous reports, with common adverse events including pruritus, alopecia, diarrhea, fatigue, and anemia [5] - Grade 3 adverse events occurred in 71.3% of patients treated with the combination, compared to 45.9% for surgery alone [5] - The pathologic complete response (pCR) rate was 57.1% for the combination treatment versus 8.6% for surgery only, indicating a significant difference [6] Group 3: Implications for Treatment - The results from the EV-303 trial may redefine the standard of care for MIBC patients who are cisplatin-ineligible, offering a new systemic treatment approach that improves survival [7][8] - The trial's findings will be discussed with global health authorities for potential regulatory filings, indicating a pathway for future approval [10] - The combination of PADCEV and KEYTRUDA is currently not approved for neoadjuvant and adjuvant treatment in this patient population, but the results suggest a transformative potential [10][9]

Core Insights - The combination of KEYTRUDA and LENVIMA shows a durable 5-year survival benefit compared to chemotherapy for patients with advanced endometrial carcinoma [1] Group 1 - KEYTRUDA plus LENVIMA demonstrates significant efficacy in improving survival rates for patients suffering from advanced endometrial carcinoma [1] - The study highlights the long-term benefits of this combination therapy over traditional chemotherapy options [1]