CADL · Candel Therapeutics, Inc.

Candel Therapeutics disclosed extended follow-up data from its pivotal phase 3 trial of aglatimagene besadenovec (CAN-2409) combined with standard-of-care radiotherapy in 745 patients with intermediate- to high-risk localized prostate cancer. The trial, conducted under FDA Special Protocol Assessment, confirmed statistical significance on the primary endpoint of prostate cancer-specific disease-free survival, with a 39% risk reduction (HR 0.61, 95% CI 0.44-0.85, p=0.0031) after a median 58 months follow-up (data cutoff March 15, 2026). Only two prostate cancer deaths occurred, one per arm. Secondary and exploratory endpoints showed consistent directional benefits, including 28% risk reductions in time to biochemical failure and salvage anticancer therapy, and a 42% reduction in time to metastasis, with metastasis rates of 1.6% (8/496) in the aglatimagene arm versus 2.8% (7/249) in placebo. In the intermediate-risk subgroup comprising 85% of patients, benefits were even more pronounced, with 41% DFS improvement and a 90% metastasis risk reduction. These results build on prior topline data from December 2024 and earlier pathological complete response findings, supporting aglatimagene's potential to enhance local and systemic control. The company plans a Biologics License Application submission in Q4 2026, positioning it as a potential first new therapy in over 20 years for this indication. CEO Paul Peter Tak highlighted the translation of biologic activity into clinical outcomes like reduced recurrence risk and delayed need for additional therapy, with ongoing monitoring expected to reveal further maturation of benefits.