Candel Therapeutics Inc. has announced results from a phase 3 clinical trial evaluating CAN-2409 (aglatimagene besadenovec) in patients with intermediate-to-high-risk localized prostate cancer. The data were presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO). The randomized, double-blind, placebo-controlled study enrolled 745 patients and assessed CAN-2409 plus valacyclovir in combination with standard of care radiotherapy versus standard of care alone. The trial met its primary endpoint, demonstrating a 30% improvement in disease-free survival (hazard ratio 0.7, p=0.0155) and a 38% improvement in prostate cancer-specific disease-free survival (hazard ratio 0.62, p=0.0046) compared to placebo. At two years, pathological complete response rates were 80.4% for the CAN-2409 group versus 63.6% for the control group (p=0.0015). Grade ≥ 3 treatment-related adverse events were similar between the treatment and control arms. The company plans to submit a Biologics License Application for CAN-2409 in the fourth quarter of 2026.