Candel Therapeutics Receives EMA Orphan Designation for CAN-2409 for the Treatment of Pancreatic Cancer
Excerpt from the Press Release:
NEEDHAM, Mass., July 24, 2025 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the European Medicines Agency (EMA) has granted Orphan Designation for CAN-2409 (aglatimagene besadenovec) for the treatment of pancreatic cancer. This designation complements CAN-2409’s existing U.S. Food and Drug Administration (FDA) Orphan Drug Designation and FDA Fast Track Designation for the treatment of pancreatic ductal adenocarcinoma (PDAC) awarded to CAN-2409 in April 2024 and December 2023, respectively, and underscores the significant unmet medical need in this disease beyond the U.S.
CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells. When administered with a prodrug (valacyclovir or acyclovir), the HSV-tk enzyme converts the prodrug into DNA-incorporating nucleotide analogs, causing immunogenic cell death and the release of tumor (neo)antigens within the tumor microenvironment (TME). This mechanism has the potential to induce an individualized, systemic immune response against multiple therapy-resistant solid tumors, including prostate cancer, non-small cell lung cancer (NSCLC), and PDAC.
The Company previously reported positive overall survival (OS) data from its randomized controlled phase 2a clinical trial of CAN-2409 plus valacyclovir in borderline resectable PDAC, demonstrating remarkable survival benefits with estimated median OS of 31.4 months in the CAN-2409 plus standard of care arm versus 12.5 months in the standard of care control arm, supported by immunological biomarker data. Notably, three of seven patients treated with CAN-2409 were still alive at the time of data cut-off (February 20, 2025) with survival of 66.0, 63.6 and 35.8 months after enrollment, respectively, suggesting a long tail of survival.
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