Candel Therapeutics' CAN-2409 Receives European Orphan Designation for Pancreatic Cancer Treatment

Candel Therapeutics, Inc., a clinical-stage biopharmaceutical company, has announced that the European Medicines Agency (EMA) has granted Orphan Designation for its investigational drug CAN-2409 for the treatment of pancreatic cancer. This designation is a significant milestone for the company, complementing the U.S. Food and Drug Administration (FDA) Orphan Drug Designation and Fast Track Designation previously awarded to CAN-2409 for pancreatic ductal adenocarcinoma (PDAC).

CAN-2409 is an off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells. When combined with a prodrug, it induces immunogenic cell death and releases tumor antigens within the tumor microenvironment, potentially triggering a systemic immune response against various solid tumors, including PDAC, prostate cancer, and non-small cell lung cancer (NSCLC).

The company has reported promising overall survival data from a phase 2a clinical trial, with patients in the CAN-2409 plus standard of care arm showing a median overall survival of 31.4 months, compared to 12.5 months in the control arm. Notably, some patients treated with CAN-2409 have survived for over five years, suggesting a long-term survival benefit.

The EMA's Orphan Designation provides Candel with several benefits, including reduced regulatory fees and up to 10 years of market exclusivity in the European Union, if the drug is approved. This recognition underscores the potential of CAN-2409 to transform the treatment landscape for pancreatic cancer, a disease with limited therapeutic options and a high unmet medical need.

With regulatory designations in both the U.S. and Europe, Candel Therapeutics is advancing its efforts to bring CAN-2409 to patients worldwide. The company's commitment to developing innovative immunotherapies like CAN-2409 represents a beacon of hope for patients battling some of the most challenging cancers.