Candel receives FDA Fast Track Designation for CAN-3110 in recurrent high-grade glioma

Candel Therapeutics, Inc.

FDA granted Fast Track Designation for CAN-3110, an HSV-1 oncolytic viral immunotherapy for recurrent HGG to improve overall survival.
Phase 1b data published in Nature (Oct 2023) showed median overall survival ~12 months after single injection vs historical <6-9 months.
Positive HSV-1 serology associated with mOS of 14 months; T-cell repertoire expansion and local/systemic antitumoral response observed.
Ongoing phase 1b trial evaluating multiple injections of CAN-3110; additional data expected in H2 2024.
Fast Track designation may accelerate development and regulatory review for this therapy-resistant brain cancer.

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