The US FDA Grants Orphan Drug Designation to Candel Therapeutics’ CAN-2409 as a Treatment for Pancreatic Cancer

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The company’s CAN-2409 has received the US FDA’s orphan drug designation based on its ongoing P-II clinical evaluation in combination with valacyclovir and SoC chemoradiation as a treatment for borderline resectable pancreatic cancer
The study, as of Mar 2024, demonstrated an improved mOS of 28.8mos. with CAN-2409 vs 12.5mos. in the control arm, a survival rate of 71.4% vs 16.7% was observed in patients post chemoradiation at 24mos. and an estimated survival of 47.6% vs 16.7% was seen at 36mos. 
Further analysis of resected tumors demonstrated anti-tumor response by altering the tumor microenvironment leading to cytotoxic lymphocyte activation and elevated proinflammatory cytokines

Ref: Candel Therapeutics | Image: Candel Therapeutics

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