Immutep Receives Positive Feedback From the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer
Immutep Receives Positive Feedback From the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer
SYDNEY, AUSTRALIA, April 17, 2024 (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, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company's upcoming TACTI-004 Phase III trial of eftilagimod alpha ("efti") for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).
澳大利亚悉尼，2024 年 4 月 17 日（GLOBE NEWSWIRE）——开发针对癌症和自身免疫性疾病的新型 LAG-3 免疫疗法的临床阶段生物技术公司Immutep Limited（澳大利亚证券交易所股票代码：IMM；纳斯达克股票代码：IMMP）（“Immutep” 或 “公司”）今天宣布，已收到西班牙药品和健康产品管理局（AEMPS）主管部门对该公司的积极反馈即将进行用于转移性非小细胞肺癌（1L NSCLC）一线治疗的依替拉吉莫德α型（“efti”）TACTI-004 三期试验。
Immutep SVP, Regulatory & Strategy, Christian Mueller commented: "We continue to be pleased with our discussions with regulatory bodies around the world regarding our upcoming pivotal TACTI-004 trial and are thankful for the positive feedback and constructive guidance received by AEMPS. Spain, a member of the EMA's Committee for Medicinal Products for Human Use (CHMP), represents an important region given the relatively large number of institutions that participated in our TACTI-002 Phase II study evaluating efti in combination with anti-PD-1 therapy in first line non-small cell lung cancer."
Immutep监管与战略高级副总裁克里斯蒂安·穆勒评论说：“我们仍然对与世界各地的监管机构就我们即将到来的关键 TACTI-004 试验进行讨论感到满意，并感谢AEMPS收到的积极反馈和建设性指导。西班牙是EMA人用药品委员会（CHMP）的成员，鉴于参与我们评估efti与抗PD-1疗法联合治疗一线非小细胞肺癌的 TACTI-002 二期研究的机构相对较多，西班牙是一个重要的地区。”
The AEMPS is supportive of Immutep moving into a registrational trial in 1L NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and statistics, and the specificities of the patient population.
AEMPS支持Immutep进入1L NSCLC的注册试验，并评估efti与无化疗方案中的抗PD-1疗法联合使用或作为包括化疗在内的三联疗法。会议讨论的其他项目包括试验设计的一般方面，包括对照组的选择和统计数据，以及患者群体的特殊性。
Additional interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing in a productive manner.
与监管机构以及其他利益相关者和潜在合作伙伴的更多互动正在以富有成效的方式进行。
About Eftilagimod Alpha (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.
关于 Eftilagimod Alpha (Efti)
Efti 是 Immutep 的专有可溶性 LAG-3 蛋白和 MHC II 类激动剂，可刺激先天免疫和适应性免疫以治疗癌症。作为同类首创的抗原呈递细胞 (APC) 激活剂，efti 与 APC 上的 MHC（主要组织相容性复合物）II 类分子结合，从而激活和增殖 CD8+ 细胞毒性 T 细胞、CD4+ 辅助性 T 细胞、树突状细胞、NK 细胞和单核细胞。它还可以上调关键生物分子的表达，例如干扰素和CXCL10，从而进一步增强免疫系统抗癌的能力。
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).
Efti正在评估各种实体肿瘤，包括非小细胞肺癌（NSCLC）、头颈部鳞状细胞癌（HNSCC）和转移性乳腺癌。其良好的安全性可实现多种组合，包括抗PD-[L] 1 免疫疗法和/或化疗。Efti已获得美国食品药品监督管理局（FDA）颁发的一线HNSCC和一线NSCLC的快速通道称号。