原始出處紀錄
重大申請已送件
Candel 計畫於 2026 年 Q4 提交 aglatimagene 治療攝護腺癌的 BLA 申請
Candel 宣布計畫於 2026 年 Q4 針對局部、中至高風險攝護腺癌提交 aglatimagene besadenovec 的 BLA 申請。公司正推進 BLA 提交前相關活動，包括 CMC 製程驗證與臨床研究報告。此外，亦宣布與 EVERSANA 建立商業合作夥伴關係，以支援潛在的美國上市。
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 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