On June 2, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported the publication of results from the Company’s randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer, which the Company first announced in December 2024, in The Lancet Oncology, one of the world’s leading peer-reviewed oncology journals (impact factor 35.9).

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"Localized prostate cancer remains an area of significant unmet need, with many patients experiencing disease recurrence after definitive radiotherapy. Innovation in this setting has been limited over the past two decades, making these peer-reviewed data particularly important for patients with intermediate- to high-risk localized prostate cancer," said Dr. Mark Garzotto, Professor of Urology and Radiation Medicine, School of Medicine, Oregon Health & Science University, and Chief of Urology at the Portland VA Medical Center. "The publication of these findings in The Lancet Oncology provides important peer-reviewed validation of the clinical significance of the results observed with aglatimagene in combination with radiotherapy."

The manuscript, titled "Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localized prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial," reports results from a pivotal phase 3 clinical trial (NCT01436968) evaluating aglatimagene plus valacyclovir in combination with standard-of-care radiotherapy administered with curative intent. The trial enrolled 745 patients and met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in DFS compared with radiotherapy alone.

The publication reports:

30% improvement in DFS in the aglatimagene arm, compared to placebo (hazard ratio 0.70; 95% confidence interval (CI) 0.52-0.94; p=0.016)
38% improvement in prostate cancer-specific DFS (prostate cancer recurrence or prostate cancer related death) (hazard ratio 0.62; 95% confidence interval 0.44-0.87; p=0.0046)
Aglatimagene improved pathological complete response rate in a post-hoc blinded review of biopsies collected two years after completion of radiotherapy, with 80% (167/209) of patients in the aglatimagene treatment arm observed with negative biopsies, versus 63% (62/98) observed in the placebo group (p=0.0018)
A generally favorable safety profile, with the most common treatment-related adverse events (chills, flu-like symptoms, fatigue, pyrexia, pollakiuria, and nausea) observed to be grades 1-2 and self-limited
While the study was not statistically powered to establish benefit in subgroups, exploratory descriptive analyses suggested clinical benefit of aglatimagene compared to placebo, independent of radiation therapy regimen and independent of androgen deprivation therapy use

The Company recently presented extended follow-up data from this phase 3 trial at the American Urological Association 2026 Annual Meeting, showing a 39% improvement in prostate cancer-specific DFS after an additional 20 months of follow-up (updated median follow-up, as of March 15, 2026, was 58 months). These data also showed consistently favorable trends across secondary and exploratory endpoints, including, time to biochemical failure, time to and incidence of metastasis, and time to salvage anti-cancer treatment in the aglatimagene arm compared with the placebo arm.

"The statistically significant increase in pathological complete response rates — observed in prostate biopsies obtained approximately two years after aglatimagene treatment and reported today in The Lancet Oncology — is particularly meaningful because biopsy findings after radiotherapy have previously been shown to predict later biochemical failure and metastasis with longer follow-up," said Garrett Nichols, M.D., Chief Medical Officer of Candel. "Together, these data strengthen our confidence that earlier tumor control, reflected in biopsy-based DFS events, may translate into durable and clinically meaningful benefit for patients."

"The publication of this pivotal phase 3 trial in The Lancet Oncology provides important peer-reviewed validation of the significance of these findings for patients with localized prostate cancer," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "Patients who elect to undergo radical treatment for localized prostate cancer do so with the goal of increasing their chance of living free from cancer while reducing the risk of recurrence and the need for future anti-cancer therapies that may carry additional toxicity and affect quality of life. These data showed a clinically meaningful reduction in disease recurrence in patients treated with aglatimagene in combination with radiotherapy. The primary endpoint findings were supported by sensitivity analyses and reinforced by secondary and exploratory endpoints and together provide a comprehensive and internally consistent body of evidence that supports the therapeutic potential of aglatimagene in localized prostate cancer."

The published manuscript is available online at The Lancet Oncology

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

(Press release, Candel Therapeutics, JUN 2, 2026, View Source [SID1234666375])