原始出處紀錄
重大申請已送件
Candel 計畫於 2026 年第 4 季提交 aglatimagene 用於攝護腺癌的 BLA 申請
該公司宣布計畫提交 aglatimagene besadenovec 用於局部、中至高風險攝護腺癌的生物製劑許可申請（BLA）。此舉是在持續進行 BLA 準備活動之後，包括 CMC 工作以及臨床研究報告和 BLA 模組的準備。提交時間表由計畫於 2026 年第 2 季進行的製程驗證活動支持。
關鍵事實
來源摘錄
EX-99.1 2 cadl-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Candel Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Highlights • Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in patients with progressive, metastatic, non-squamous, non-small cell lung cancer (NSCLC) despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026 • Company plans to submit a Biologics License Application (BLA) for aglatimagene in localized, intermediate-to high-risk prostate cancer in Q4 2026 • Company announced investigational new drug (IND) clearance for linoserpaturev (CAN-3110) in recurrent high-grade glioma (rHGG) to support enabling work for a potential future randomized controlled phase 2 d