原始来源记录
重大申请已提交
Candel 计划于 2026 年 Q4 提交 aglatimagene 前列腺癌 BLA 申请
该公司宣布计划为 aglatimagene besadenovec 提交生物制品许可申请（BLA），用于局部、中高风险前列腺癌，提交时间定于 2026 年 Q4。此前正在进行 BLA 准备工作，包括 CMC 工作以及临床研究报告和 BLA 模块的准备。提交时间表由计划于 2026 年 Q2 开展的工艺验证活动提供支持。
关键事实
来源摘录
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