FDA Grants Candel Therapeutics Orphan Drug Designation to CAN-2409 for the Treatment of Pancreatic Cancer

April 11, 2024

DENVER, Colo., Apr 11, 2024 (247marketnews.com)- Candel Therapeutics (NASDAQ:CADL) stated that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to CAN-2409 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.”

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