Key insights
- Candel Therapeutics reported positive Phase 3 data for its prostate cancer drug, aglatimagene besadenovec, showing a 41% reduction in recurrence or death risk. Exploratory analyses indicated significant improvements in time to biochemical failure, metastasis, and need for salvage therapy. Biopsy data also showed higher negative biopsy rates in the treatment arm. The company plans to submit a Biologics License Application to the FDA in Q4 2026, with further data presentations expected in 2027. This news suggests a strong potential catalyst for CADL.
Candel Therapeutics, Inc. (Nasdaq: CADL) announced clinical and biomarker data from its phase 3 PrTK03 and phase 2 PrTK05 trials evaluating aglatimagene besadenovec in patients with intermediate-risk localized prostate cancer, according to a company press release.
In the PrTK03 phase 3 trial, 635 patients with intermediate-risk disease treated with aglatimagene plus external beam radiation therapy (EBRT) showed a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death compared with placebo plus EBRT, with a hazard ratio of 0.59 (95% CI 0.41–0.84; p=0.0034), based on follow-up through March 15, 2026, with a median of 58.0 months.
Exploratory analyses from the same trial showed a 52% improvement in time to biochemical failure (HR 0.48), a 90% improvement in time to metastasis (HR 0.10), and a 49% reduction in time to salvage anticancer therapy (HR 0.51).
Biopsy data from 277 evaluable intermediate-risk patients, collected 22–26 months after treatment, showed negative biopsy rates of 76.6% in the aglatimagene arm versus 60.7% in the control arm. Positive biopsies were recorded in 20.7% of the aglatimagene group compared with 38.2% in the control group (p=0.0026).
Data from the phase 2 PrTK05 trial, involving 13 aglatimagene-treated patients and 6 standard-of-care controls, showed systemic expansion of CD8-positive effector and effector-memory T-cell populations following local aglatimagene administration. Formal comparison with controls is ongoing.
Candel said biodistribution and shedding data from PrTK05 are being compiled for inclusion in a Biologics License Application (BLA) the company plans to submit to the U.S. Food and Drug Administration in the fourth quarter of 2026. The company also said it intends to submit the data for presentation at a scientific conference and for potential publication in a peer-reviewed journal in 2027.
Aglatimagene has not been approved by the FDA or any other regulatory authority for any use.
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