Candel Therapeutics Inc. (CADL), a clinical-stage biopharmaceutical company, on Tuesday announced encouraging results from the Phase 3 trial for Aglatimagene in treating high-risk localised prostate cancer. The data was published in The Lancet Oncology journal.
Aglatimagene besadenovec (CAN-2409) is a multimodal immunotherapy candidate comprising of an investigational, off-the-shelf, replication-defective adenovirus that delivers the Herpes simplex virus thymidine kinase (HSV-tk) gene directly to tumors, resulting in immunogenic death of the cancer cells.
The multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluated Aglatimagene in combination with valacyclovir and a standard-of-care radiotherapy in 745 patients with localized prostate cancer. Results indicated a 30% improvement in disease-free survival (DFS), and a 38% improvement in prostate cancer-specific DFS compared to the placebo. Further data from an additional 20-month follow-up period showed a 39% prostate cancer-specific DFS.
A post-hoc blinded review of biopsies collected two years after completion of radiotherapy was conducted. In the review, 80% of patients treated with aglatimagene showed negative biopsies, compared to 63% in the placebo group.
Additionally, the drug showed a generally favorable safety profile.
CADL is currently trading at $8.28, down 2.7%.
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