Research & Development
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
11 April 2024 -

Candel Therapeutics Inc (Nasdaq:CADL), a clinical stage biopharmaceutical company, announced on Thursday that it has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its multimodal biological immunotherapy candidate CAN-2409 in the treatment of pancreatic cancer.

This designation follows promising results from a phase 2 clinical trial, demonstrating a significant increase in median overall survival to 28.8 months with CAN-2409 treatment compared to 12.5 months in the control group.

Survival rates at 24 months were 71.4% for CAN-2409 patients versus 16.7% for the control group, and at 36 months, estimated survival rates were 47.6% versus 16.7% respectively. The treatment was well-tolerated with no new safety concerns observed.

The FDA's Orphan Drug Designation provides financial incentives for clinical development and the potential for up to seven years of marketing exclusivity in the United States for the designated orphan indication.