Candel Therapeutics, Inc., a clinical-stage biopharmaceutical company, has announced that the European Medicines Agency (EMA) has granted Orphan Designation for its drug CAN-2409, aimed at treating pancreatic cancer. This designation is a significant milestone for the company, as it complements the drug’s existing U.S. Food and Drug Administration (FDA) Orphan Drug Designation and FDA Fast Track Designation, underscoring the global recognition of CAN-2409’s potential in addressing the unmet medical needs in pancreatic cancer treatment.

CAN-2409 is an investigational therapy designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells, which, when combined with a prodrug, induces immunogenic cell death and releases tumor antigens. This mechanism has shown promise in inducing a systemic immune response against various solid tumors, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and prostate cancer. The company has reported positive survival data from a phase 2a clinical trial, with patients in the CAN-2409 treatment arm showing significantly longer median overall survival compared to the control group.

The EMA’s Orphan Designation provides Candel Therapeutics with several benefits, including reduced regulatory fees and up to 10 years of market exclusivity in the European Union upon approval. This recognition is a testament to the drug’s potential to transform the treatment landscape for pancreatic cancer, a disease known for its poor prognosis and limited therapeutic options. The company’s leadership has expressed commitment to advancing CAN-2409 through development and regulatory processes to make this innovative therapy available to patients worldwide.

With regulatory designations across multiple solid tumor indications, CAN-2409 represents a promising advancement in cancer immunotherapy. The drug’s ability to remodel the tumor microenvironment and extend survival offers hope for patients facing this challenging disease. As Candel Therapeutics continues its development efforts, the focus remains on bringing CAN-2409 to those in need, marking a significant step forward in the fight against pancreatic cancer.

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