The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel Therapeutics’ most advanced multimodal biological immunotherapy candidate, for the treatment of pancreatic cancer.
“We recently reported data from the phase 2 randomized clinical trial of CAN-2409 in borderline resectable pancreatic cancer, showing that CAN-2409, when added to standard of care, more than doubled the median overall survival obtained with standard of care alone,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel.
“We are pleased that the FDA has now granted Candel with both Orphan Drug and Fast Track Designation to this program, as we seek to reshape the treatment paradigm in pancreatic cancer.”
“Obtaining Orphan Drug Designation marks a significant milestone for Candel, as we continue to develop CAN-2409 for pancreatic cancer,” said Garrett Nichols. M.D., M.S., Chief Medical Officer at Candel.
“We are excited by this FDA designation, which further supports Candel’s efforts in the development of medicines to cure less prevalent yet challenging to treat cancers. The evidence base for CAN-2409 is growing, as we read out clinical trials in patients with difficult-to-treat cancers, such as our recent results in pancreatic ductal adenocarcinoma, and non-small cell lung cancer later in the current quarter.”
Earlier this month, Candel reported updated overall survival data from the ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC).
The observed data from a March 29, 2024 cut-off showed notable improvement in estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group.
At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation. At 36 months, estimated survival was 47.6% in the CAN-2409 group versus 16.7% in the control group.
No new safety signals were observed, providing further support that multiple injections of CAN-2409 were generally well tolerated, with no dose-limiting toxicities and no cases of pancreatitis. Analysis of resected tumors showed treatment with CAN-2409 modified the tumor microenvironment, with the local recruitment and activation of cytotoxic lymphocytes and increased levels of proinflammatory cytokines, supporting the activation of a robust systemic anti-tumor immune response.
