Candel Therapeutics Inc. (CADL), a clinical-stage biopharmaceutical company, on Friday released positive Phase 3 results reinforcing the benefits of Aglatimagene in the treatment of prostate cancer.
Aglatimagene besadenovec (CAN-2409) is an investigational, replication-defective adenovirus delivering herpes simplex virus thymidine kinase (HSV-tk) directly to solid tumors. Currently being evaluated for the treatment of intermediate-to-high risk localized prostate cancer, the immunotherapy may potentially be the first approved treatment in over 10 years.
The Phase 3 pivotal, randomized, double-blind, placebo-controlled study conducted with 745 patients on aglatimagene showed a 39% improvement in prostate cancer disease-free survival (PCa-DFS) in the 20-month follow-up period. Additionally, the aglatimagene showed lower rates of metastatic disease, improved times to biochemical failure, and improved rates of pathological complete response. Analyses of the 2-year biopsies demonstrated an elimination of cancer at the microscopic level, indicating that histological changes precede clinical evidence of recovery.
The company plans to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by the fourth quarter of this year.
CADL closed Friday at $8.77, down 1.57%. In the pre-market, shares are trading at $8.64, down 1.48%.
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