Candel Therapeutics receives FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer

Candel Therapeutics, Inc.

FDA granted Orphan Drug Designation for CAN-2409 (multimodal immunotherapy) in pancreatic cancer.
Fast Track Designation also previously granted; both designations support development.
Phase 2 data showed median OS 28.8 mo (CAN-2409+SoC) vs 12.5 mo (SoC alone); 24-mo survival 71.4% vs 16.7%.
No new safety signals; CAN-2409 generally well tolerated with no pancreatitis or DLTs.
Orphan Drug status provides tax credits, fee waivers, and 7-year market exclusivity if approved.

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