Candel Therapeutics' CAN-2409 Gains EMA Orphan Designation for Pancreatic Cancer

Candel Therapeutics, Inc., a clinical-stage biopharmaceutical company, has achieved a significant milestone with the European Medicines Agency (EMA) granting Orphan Designation for its investigational drug, CAN-2409, aimed at treating pancreatic cancer. This recognition highlights the drug's potential to address a critical unmet medical need in Europe, complementing its existing U.S. FDA Orphan Drug and Fast Track Designations. CAN-2409, an innovative multimodal biological immunotherapy, works by inducing an individualized immune response against solid tumors, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and prostate cancer. The company's phase 2a clinical trial results have shown promising survival benefits, with some patients living significantly longer than expected. The EMA's Orphan Designation offers Candel Therapeutics various benefits, including market exclusivity and reduced regulatory fees, accelerating the path to making CAN-2409 available to patients in need.

The development of CAN-2409 represents a breakthrough in cancer treatment, particularly for pancreatic cancer, which has limited therapeutic options. The drug's ability to remodel the tumor microenvironment and extend survival offers hope to patients facing this challenging disease. With regulatory designations across multiple solid tumor indications, CAN-2409 is poised to make a substantial impact in oncology. Candel Therapeutics continues to advance its regulatory strategy globally, emphasizing its commitment to bringing innovative therapies to patients. For more information, visit Candel Therapeutics, Inc..