Friday, April 12, 2024
Candel Therapeutics, Inc. (Candel), publicly traded under the symbol CADL on the Nasdaq, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its leading candidate, CAN-2409, which targets pancreatic cancer. CAN-2409 is a novel multimodal biological immunotherapy developed to combat cancer.
Dr. Paul Peter Tak, serving as President and CEO of Candel, shared recent phase 2 trial findings, demonstrating significant efficacy. When CAN-2409 was combined with the standard treatment for borderline resectable pancreatic cancer, median overall survival more than doubled compared to standard treatment alone. This accomplishment led to the FDA granting both Orphan Drug and Fast Track Designation to CAN-2409.
Dr. Garrett Nichols, Candel's Chief Medical Officer, underscored the importance of this recognition in advancing their mission to tackle challenging cancers. Encouraging results in pancreatic ductal adenocarcinoma and forthcoming data in non-small cell lung cancer further validate the potential of CAN-2409.
Recent updates from Candel revealed substantial improvements in overall survival rates with CAN-2409 compared to standard care alone. Notably, the CAN-2409 group showed significantly higher survival rates at the 24-month mark. Importantly, the therapy exhibited a favorable safety profile, with no new safety concerns detected.
CAN-2409 functions by delivering the herpes simplex virus thymidine kinase (HSV-tk) gene to the tumor, initiating a systemic anti-tumor immune response. This innovative mechanism aims to activate CD8+ T cells against the tumor and distant metastases, potentially addressing a broad range of solid tumors.
Pancreatic cancer, particularly pancreatic ductal adenocarcinoma, remains a formidable challenge with limited treatment options. While surgical resection offers the best chance of cure, recurrence rates are high. CAN-2409 holds promise for improving outcomes in this challenging cancer type.
Candel is presently evaluating CAN-2409 across various cancer types, including non-small cell lung cancer and localized prostate cancer, with promising results thus far. With its unique mechanism of action and encouraging clinical data, CAN-2409 represents a potential breakthrough in cancer treatment.
Source: globenewswire.com
