Candel Therapeutics Announces CAN-2409 Significantly Improves Disease-Free Survival In Prostate Cancer, Showing Benefit Across Radiation Modalities In Phase 3 Trial

Author: Benzinga Newsdesk | September 29, 2025 07:20am

• CAN-2409 improved disease-free survival in patients with intermediate-to-high-risk, localized prostate cancer compared to placebo in patients treated with either conventional or moderate hypofractionated radiotherapy with curative intent, independent of the specific modality of radiation therapy used

NEEDHAM, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (NASDAQ: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, presented subgroup analyses focused on the radiation regimen from the Company's positive phase 3 clinical trial of CAN-2409 (aglatimagene besadenovec) in patients with intermediate-to-high-risk localized prostate cancer at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO).

Current standard-of-care radiation therapy for intermediate-to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately ~30% of patients experience disease recurrence within 10 years.

The Company has previously presented data from a randomized phase 3 clinical trial of CAN-2409 plus valacyclovir vs. placebo added to standard of care radiotherapy with curative intent in patients with localized prostate cancer. The press release is posted on the investor relations section of our website, available here. The randomized, double-blind, placebo-controlled, multicenter phase 3 trial (NCT01436968) enrolled 745 patients with intermediate-to-high-risk localized prostate cancer randomized 2:1 to either CAN-2409 plus valacyclovir in combination with standard of care or standard of care alone, with experimental treatment administered before and during radiation therapy. The trial achieved its primary endpoint with a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and demonstrated a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046). At two years, pathological complete response rates were 80.4% as compared to 63.6% observed in the control arm (p=0.0015).

This study represents the first potential advancement in localized, non-metastatic prostate cancer in more than 20 years. The Company today released additional information from its subgroup analysis of the phase 3 data showing that CAN-2409's activity was independent of the radiation modality used in the trial.

Posted In: CADL