Candel Therapeutics Secures EMA Orphan Designation for Pancreatic Cancer Therapy
Friday, July 25, 2025
Candel Therapeutics has received Orphan Designation from the European Medicines Agency (EMA) for its lead investigational immunotherapy candidate, CAN-2409, for the treatment of pancreatic cancer.
Pancreatic cancer is a serious and often aggressive form of cancer that begins in the tissues of the pancreas an organ located behind the stomach that helps with digestion and blood sugar regulation. The most common type is pancreatic ductal adenocarcinoma (PDAC), which accounts for more than 90% of cases.
CAN-2409 (aglatimagene besadenovec) is an off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene directly to tumour cells. Once administered alongside a prodrug such as valacyclovir or acyclovir, the therapy triggers immunogenic cell death, leading to the release of tumour neoantigens and activation of the immune system.
This designation adds to CAN-2409’s existing regulatory recognitions in the United States, including Orphan Drug and Fast Track status from the U.S. Food and Drug Administration (FDA), highlighting the continued unmet medical need in pancreatic ductal adenocarcinoma (PDAC).
The designation provides several incentives, including reduced regulatory fees, protocol assistance, and up to ten years of market exclusivity in the EU upon approval.
In addition to its latest EMA designation, CAN-2409 has received multiple FDA recognitions, including Fast Track Designation for NSCLC and prostate cancer, and Regenerative Medicine Advanced Therapy (RMAT) status for intermediate-to-high-risk, localised prostate cancer.
More than 1,000 patients have been treated with CAN-2409 to date, with a favourable safety profile observed across clinical trials. Preclinical and clinical studies have also demonstrated promising outcomes when CAN-2409 is used as a monotherapy or combined with standard treatments such as radiotherapy, chemotherapy, surgery, and immune checkpoint inhibitors.
Candel Therapeutics continues to progress CAN-2409’s development across global markets, with the aim of offering a new therapeutic option for patients with difficult-to-treat solid tumours.
Source: candeltx.com
