Candel Therapeutics Granted FDA RMAT Designation for CAN-2409 in Prostate Cancer Treatment
Thursday, May 29, 2025
Candel Therapeutics has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for CAN-2409, its lead biological immunotherapy candidate, for the treatment of newly diagnosed localised prostate cancer in patients with intermediate-to-high-risk disease. The candidate had previously received Fast Track Designation for the same indication.
The RMAT designation aims to support the development of regenerative therapies intended to treat or reverse serious conditions where early clinical data shows potential to meet unmet medical needs. The designation offers closer guidance from the FDA, as well as possible eligibility for accelerated review processes such as Priority Review, Rolling Review, and quicker assessment of the Biologics License Application (BLA).
The RMAT status for CAN-2409 was based on positive results from a Phase 3 randomised, placebo-controlled trial. The trial assessed the combination of CAN-2409 and valacyclovir (a prodrug), alongside standard external beam radiotherapy, in patients with localised, intermediate-to-high-risk prostate cancer.
Data released in December 2024 showed the trial met its main goal. The combination therapy significantly improved disease-free survival (DFS), showing a 30% reduction in the risk of cancer recurrence or death (HR 0.70; p=0.0155) compared to the placebo group. Prostate-specific DFS improved with a 38% risk reduction (HR 0.62; p=0.0046). A higher proportion of patients receiving CAN-2409 achieved a PSA nadir of less than 0.2 ng/ml (67.1% vs. 58.6%; p=0.0164). In addition, 80.4% of patients had a complete pathological response in post-treatment biopsies at two years, compared to 63.6% in the placebo group (p=0.0015). The safety profile remained consistent with previous studies and no new safety concerns were observed. The Phase 3 study design, including its primary endpoint, was developed in line with a Special Protocol Assessment (SPA) agreed with the FDA.
CAN-2409, also known as aglatimagene besadenovec, is a replication-defective adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumour cells. Once inside the tumour, the HSV-tk enzyme converts the prodrug valacyclovir into a compound that kills surrounding cancer cells. This process is designed to trigger a personalised CD8+ T-cell immune response, targeting both treated tumours and untreated metastases. The treatment is being explored across a range of solid tumours due to its broad potential and mechanism of action.
To date, more than 1,000 patients have been treated with CAN-2409, showing a favourable safety profile. The therapy has demonstrated promise both on its own and when combined with radiotherapy, surgery, chemotherapy, or immune checkpoint inhibitors.
In addition to the prostate cancer programme, CAN-2409 has shown encouraging results in Phase 2a trials for non-small cell lung cancer (NSCLC) and borderline resectable pancreatic ductal adenocarcinoma (PDAC). The FDA has also granted Fast Track Designation for CAN-2409 in the treatment of PDAC and stage III/IV NSCLC in specific patient groups. The therapy has also received Orphan Drug Designation for PDAC.
The company expects to file a Biologics License Application for CAN-2409 by the end of 2026.
Source: globenewswire.com
