原始来源记录
重大申请已提交
Candel 计划于 2026 年 Q4 提交 aglatimagene 的 BLA，用于前列腺癌
Candel 宣布计划于 2026 年 Q4 提交 aglatimagene besadenovec 的 BLA，用于局部、中高危前列腺癌。公司正在推进 BLA 提交前活动，包括 CMC 工艺验证和临床研究报告。同时宣布与 EVERSANA 建立商业合作，以支持潜在的美国上市。
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 First Quarter 2026 Financial Results and Recent Corporate Highlights • Company plans to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene or CAN-2409) in localized, intermediate- to high-risk prostate cancer in Q4 2026 • Announced purpose-built commercial partnership with EVERSANA® to support potential U.S. launch of aglatimagene in localized prostate cancer • Company reported extended survival tail observed in trial of aglatimagene in advanced non-small cell lung cancer (NSCLC) patients with inadequate response to immune checkpoint inhibitors (ICI) • Company to report extended follow-up data from the positive phase 3 clinical trial of aglatimagene in patients wit