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).
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."
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.
Additional interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing in a productive manner.
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.
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).
澳大利亞悉尼，2024 年 4 月 17 日（GLOBE NEWSWIRE）——開發針對癌症和自身免疫性疾病的新型 LAG-3 免疫療法的臨床階段生物技術公司Immutep Limited（澳大利亞證券交易所股票代碼：IMM；納斯達克股票代碼：IMMP）（“Immutep” 或 “公司”）今天宣佈，已收到西班牙藥品和健康產品管理局（AEMPS）主管部門對該公司的積極反饋即將進行用於轉移性非小細胞肺癌（1L NSCLC）一線治療的依替拉吉莫德α型（“efti”）TACTI-004 三期試驗。
Immutep監管與戰略高級副總裁克里斯蒂安·穆勒評論說：“我們仍然對與世界各地的監管機構就我們即將到來的關鍵 TACTI-004 試驗進行討論感到滿意，並感謝AEMPS收到的積極反饋和建設性指導。西班牙是EMA人用藥品委員會（CHMP）的成員，鑑於參與我們評估efti與抗PD-1療法聯合治療一線非小細胞肺癌的 TACTI-002 二期研究的機構相對較多，西班牙是一個重要的地區。”
AEMPS支持Immutep進入1L NSCLC的註冊試驗，並評估efti與無化療方案中的抗PD-1療法聯合使用或作爲包括化療在內的三聯療法。會議討論的其他項目包括試驗設計的一般方面，包括對照組的選擇和統計數據，以及患者群體的特殊性。
與監管機構以及其他利益相關者和潛在合作伙伴的更多互動正在以富有成效的方式進行。
關於 Eftilagimod Alpha (Efti)
Efti 是 Immutep 的專有可溶性 LAG-3 蛋白和 MHC II 類激動劑，可刺激先天免疫和適應性免疫以治療癌症。作爲同類首創的抗原呈遞細胞 (APC) 激活劑，efti 與 APC 上的 MHC（主要組織相容性複合物）II 類分子結合，從而激活和增殖 CD8+ 細胞毒性 T 細胞、CD4+ 輔助性 T 細胞、樹突狀細胞、NK 細胞和單核細胞。它還可以上調關鍵生物分子的表達，例如干擾素和CXCL10，從而進一步增強免疫系統抗癌的能力。
Efti正在評估各種實體腫瘤，包括非小細胞肺癌（NSCLC）、頭頸部鱗狀細胞癌（HNSCC）和轉移性乳腺癌。其良好的安全性可實現多種組合，包括抗PD-[L] 1 免疫療法和/或化療。Efti已獲得美國食品藥品監督管理局（FDA）頒發的一線HNSCC和一線NSCLC的快速通道稱號。
