Candel Therapeutics announces U.S. FDA granted ODD to CAN-2409

Candel Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, to CAN-2409, Candel’s 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.”