2022年10月31日

美國FDA批準CBMG公司的新型自體TIL療法C-TIL051的IND申請，用於治療非小細胞肺癌(NSCLC)患者，馬裏蘭州羅克維爾，2022年10月31日/美通社/Cellular Biomedicine Group Inc. (CBMG或“公司”)是一家生物製藥公司，開發用於治療癌症的創新細胞免疫療法。近日，美國食品藥品監督管理局(FDA)宣布批準了其新型腫瘤浸潤淋巴細胞(TIL)產品C-TIL051的研究新藥(IND)申請，用於抗pd1治療複發或難治性的晚期非小細胞肺癌(NSCLC)患者的一期臨床開發。C-TIL051是一種自體過繼細胞療法，由患者的體外擴增淋巴細胞組成，采用CBMG的專有製造工藝。“對於那些麵臨有限治療選擇的NSCLC患者來說，這是一個非常好的消息。C-TIL051可能提供一種替代治療方法，我們的臨床前數據顯示C-TIL051可能有更好的潛力。我們正與臨床機構密切合作，計劃很快啟動C-TIL051一期臨床試驗，”CBMG董事長兼首席執行官劉偉碩(Bizuo)表示。FDA批準C-TIL051 IND對CBMG來說是一個重要的裏程碑。我們計劃在不久的將來在馬裏蘭州羅克維爾的GMP工廠開始生產臨床批次的C-TIL051。”C-TIL051是在CBMG位於馬裏蘭州羅克維爾的最先進的GMP工廠生產和發布的，使用的專有工藝可以比傳統的TIL製造方法更快速、更有效地達到臨床劑量。 The process involves ex vivo expansion of tumor infiltrating lymphocytes in a two-step process. C-TIL051 has not been previously studied in human clinical trials however the rationale for developing C-TIL051 was based on initial NSCLC TIL studies demonstrating encouraging safety and efficacy results (NCT03215810, NCT03645928). About CBMG Cellular Biomedicine Group Inc. (CBMG) develops proprietary cell therapies for the treatment of cancerous diseases. CBMG operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the United States. CBMG currently conducts ongoing studies in Chimeric antigen receptor (CAR) T-cell therapies, including C-CAR039, an anti-CD19&CD20 bi-specific CAR (BiCAR) Phase 1b trial targeting treatment for non-Hodgkin lymphoma (NHL), and is conducting studies in tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors. Company Contact: