FDA grants Fast Track Designation to Candel's CAN-2409 for pancreatic cancer

Candel Therapeutics, Inc.

FDA Fast Track Designation for CAN-2409 (adenovirus immunotherapy) plus valacyclovir in pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.
Phase 2 interim data (Nov 2023): 71.4% estimated survival at 24 and 36 months with CAN-2409 + SoC vs 16.7% for SoC alone in borderline resectable PDAC.
Updated overall survival data from interim analysis expected Q2 2024.
CAN-2409 shown to activate immunologic antitumoral response in 'cold' tumors.

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