Candel Therapeutics, Inc. (CADL) to Present Positive Phase 3 Prostate Cancer Data at ASCO 2025

Candel Therapeutics, Inc. (NASDAQ:CADL) has announced a major breakthrough in prostate cancer treatment, revealing that its Phase 3 trial of CAN-2409, an innovative immunotherapy, achieved both its primary and secondary endpoints in patients with intermediate-to-high-risk localized prostate cancer. The trial, to be presented at the 2025 ASCO Annual Meeting, demonstrated a statistically significant 30% reduction in the risk of cancer recurrence or death (hazard ratio 0.7, p=0.0155) for patients receiving CAN-2409 with valacyclovir and standard radiation therapy, compared to placebo.

Notably, the study reported an 80.4% pathological complete response rate versus 63.6% in the control group, and a significant increase in the proportion of patients reaching very low PSA levels, all while maintaining a favorable safety profile with minimal treatment-related adverse events. This marks the first time in over 20 years that a multicenter, randomized Phase 3 trial in localized prostate cancer has met such rigorous efficacy benchmarks, potentially redefining curative treatment standards for this patient population.

Candel Therapeutics, Inc. (NASDAQ:CADL) plans to submit a Biologics License Application for CAN-2409 in late 2026, aiming to provide a new, less toxic option for patients seeking to avoid recurrence and long-term disease progression.

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