Candel Therapeutics’ pancreatic cancer treatment granted ODD by FDA

Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CAN-2409, Candel’s immunotherapy candidate, for the treatment of pancreatic cancer.
Candel has previously reported updated overall survival data from its ongoing phase 2 clinical trial of CAN-2409 plus valacyclovir, along with standard-of-care chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC). This data showed a ‘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’, according to the company’s press release.
Paul Peter Tak MD PhD FMedSci, president and chief executive officer of Candel Therapeutics, commented: “We recently reported data from the phase 2 randomised 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. We are pleased that the FDA has now granted Candel with both Orphan Drug and Fast Track Designation to this programme, as we seek to reshape the treatment paradigm in pancreatic cancer.”
Garrett Nichols MD MS, chief medical officer at Candel, added: “Obtaining ODD marks a significant milestone for Candel, as we continue to develop CAN-2409 for pancreatic cancer. 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.”