原始来源记录
重大申请已提交
Candel 计划于 2026 年 Q4 提交 CAN-2409 用于前列腺癌的 BLA
该公司宣布将于 2026 年 Q4 提交 CAN-2409 用于中高危局限性前列腺癌的 BLA。该申报将由积极的 3 期试验数据支持，数据显示前列腺癌特异性 DFS 具有统计学显著改善（HR 0.62，p=0.0046），并由正在进行的 CMC 和监管准备活动支持。
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 Third Quarter 2025 Financial Results and Recent Corporate Highlights • Presented new subgroup analyses from phase 3 clinical trial of CAN-2409 in localized prostate cancer at the American Society for Radiation Oncology (ASTRO) 2025 meeting, demonstrating improved prostate cancer-specific disease-free survival (DFS), independent of radiation therapy modality utilized • Company plans to initiate pivotal phase 3 clinical trial of CAN-2409 in patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) and progressive disease, despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026 • Announced encouraging updated survival data for patients enrolled in its phase 1b clinical trial of CA