Biotech stocks lit up the after-hours session on September 9, 2025, with several small- and mid-cap names posting sharp gains following fresh clinical updates, insider buying, and investor conference appearances. Companies like Immutep, Nautilus Biotechnology, Pliant Therapeutics, Phio Pharmaceuticals, and Kura Oncology all saw renewed momentum, driven by near-term catalysts that are drawing attention across the healthcare sector. Here's a quick look at the biggest movers and what's fueling their post-mark ...

Data to be presented in the Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers session at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting SYDNEY, AUSTRALIA, Sept. 08, 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 abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connectiv ...

Based on its review of the encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 (KEYNOTE- C34) Phase IIb trial evaluating efti in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti- PD-1 KEYTRUDA (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination's further development. Immutep is a late-stage biotechnology company developing novel immunotherapies for canc ...

EFTI DEVELOPMENT PROGRAM IN ONCOLOGY LUNG CANCER TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC Media Release SYDNEY, AUSTRALIA, July 30, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 30 June 2025 (Q4 FY25). Immutep's pivotal TACTI-004 Phase III trial is on track and continu ...

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 ...

SYDNEY, AUSTRALIA, July 28, 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 three abstracts for clinical trials evaluating its first-in-class MHC Class II agonist, eftilagimod alfa (efti), have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2025 taking place 17-21 October in Berlin, Germany. Australian Investors/Media: A Pro ...

SYDNEY, AUSTRALIA, June 23, 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 positive initial efficacy data and continued favourable safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. Initial pharmacological data from placebo-controlled, double-blind Phase ...

文章核心观点 - Immutep公司宣布EFTISARC - NEO II期试验达到主要终点，efti与放疗加KEYTRUDA®的新辅助治疗组合在可切除软组织肉瘤中显著提高肿瘤透明化/纤维化率，后续将在医学会议公布详细结果 [1][7] 试验结果 - EFTISARC - NEO II期试验中，新辅助治疗组合的肿瘤透明化/纤维化率显著超过预设中位数35%，历史放疗数据为15% [1] - 2024年11月初步分析显示，21例可切除STS患者的组合疗法肿瘤透明化/纤维化率中位数达50% [3] - 肿瘤透明化/纤维化与STS患者总生存期和无复发生存期改善相关 [2] 研究人员观点 - 化疗-free的efti组合远超试验主要终点目标，efti激活抗原呈递细胞引发免疫反应，转化肿瘤微环境，产生抗癌疗效 [3] 行业情况 - STS是罕见病，医疗需求未满足，预后差，2025年美国预计新增病例约13,520例，死亡约5,420例 [4] eftilagimod alfa药物信息 - efti是Immutep公司的可溶性LAG - 3蛋白和MHC II类激动剂，激活抗原呈递细胞，刺激先天和适应性免疫治疗癌症 [5] - efti正在评估用于多种实体瘤，安全性好，可与多种疗法联用，获FDA一线HNSCC和NSCLC快速通道认定 [6] 公司信息 - Immutep是晚期生物技术公司，开发癌症和自身免疫疾病免疫疗法，是LAG - 3疗法先驱，产品组合利用LAG - 3调节免疫反应 [7]

文章核心观点 - 截至2025年5月6日，INSIGHT - 003试验中，eftilagimod alpha（efti）与抗PD - 1疗法KEYTRUDA及双联化疗联用，一线治疗晚期或转移性非鳞状非小细胞肺癌取得60.8%的缓解率和90.2%的疾病控制率，数据增强了公司对efti在TACTI - 004试验中为非小细胞肺癌患者带来新标准治疗的信心 [1][2] 试验情况 - INSIGHT - 003是由法兰克福临床癌症研究IKF和其他德国中心开展的研究，作为正在进行的I期INSIGHT试验的第三组，评估efti皮下注射与抗PD - 1疗法和化疗静脉注射的三联组合疗法在一线非小细胞肺癌患者中的安全性、耐受性和初步疗效 [11] 患者情况 - INSIGHT - 003研究中约92%的可评估患者PD - L1 TPS <50%，其中49%的患者PD - L1肿瘤比例评分（TPS）为1 - 49%，43%的患者PD - L1 TPS <1% [3] 疗效数据 - 所有可评估患者数据显示，与非鳞状一线非小细胞肺癌抗PD - 1和双联化疗注册试验的历史对照相比，各PD - L1表达水平的总体缓解率（ORR）均显著提高，无论PD - L1表达如何（TPS 0 - 100%）缓解率为60.8%，高于历史对照的48.0% [4] - TPS <50%的患者（N = 47）中，含efti的三联组合疗法缓解率为59.6%，高于历史对照的40.8% [5] - 不同PD - L1表达水平下具体缓解率：TPS 0 - 100%（N = 51）ORR为60.8%，DCR为90.2%；TPS <1%（N = 22）ORR为54.5%，DCR为86.4%；TPS 1 - 49%（N = 25）ORR为64.0%，DCR为92.0%；TPS <50%（N = 47）ORR为59.6%，DCR为89.4%；TPS ≥50%（N = 4）ORR为75.0%，DCR为100% [6] - 高PD - L1表达（TPS >50%）患者中ORR为75.0%，高于历史对照的62.1%；低PD - L1表达（TPS 1 - 49%）患者中ORR为64.0%，高于历史对照的49.2%；PD - L1表达阴性（TPS <1%）患者中ORR为54.5%，高于历史对照的32.3% [8] 安全性 - 一线非小细胞肺癌三联组合疗法安全性良好，无新的安全信号 [9] 下一步计划 - 预计在2025年及以后的医学会议上公布该试验的更多数据更新 [10] 相关产品 - Efti是Immutep专有的可溶性LAG - 3蛋白和MHC II类激动剂，可刺激先天和适应性免疫治疗癌症，作为首创的抗原呈递细胞（APC）激活剂，能结合APC上的MHC II类分子，激活和增殖多种免疫细胞，还能上调关键生物分子表达以增强免疫系统抗癌能力 [12] - Efti正在评估用于多种实体瘤，包括非小细胞肺癌、头颈部鳞状细胞癌和转移性乳腺癌，其良好的安全性使其可与多种疗法联用，已获得美国FDA一线头颈部鳞状细胞癌和一线非小细胞肺癌的快速通道指定 [13] 公司介绍 - Immutep是一家晚期生物技术公司，开发用于癌症和自身免疫性疾病的新型免疫疗法，是淋巴细胞激活基因 - 3（LAG - 3）相关疗法的先驱，其多元化产品组合利用LAG - 3刺激或抑制免疫反应的能力，致力于为有需要的患者带来创新治疗方案并为股东创造最大价值 [14]

公司概况 - Immutep Limited是一家专注于免疫疗法的生物技术公司 股票代码为IMMP和PRRUF [1] - 公司目前全力开发LAG-3免疫检查点抑制剂作为核心投资方向 [1] 技术背景 - 公司研究基础建立在生物化学和临床试验分析的专业知识上 [1] - LAG-3靶点属于新兴的免疫检查点抑制剂领域 具有肿瘤治疗潜力 [1] 行业分析 - 生物科技行业投资需结合临床科学进行深度尽职调查 [1] - 免疫治疗领域存在技术门槛 投资者需理解底层科学原理 [1] （注：文档2和3均为披露声明 根据任务要求已过滤 文档1中未提及财务数据或具体临床试验进展 故相关部分未总结）