Candel Therapeutics Says FDA Grants Orphan Drug Designation For CAN-3110 To Treat High-grade Glioma

(RTTNews) - Biopharmaceutical company Candel Therapeutics, Inc. (CADL) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-3110 for the treatment of recurrent high-grade glioma (rHGG). Glioblastoma (GBM) is the most common and aggressive form of high-grade glioma.

The FDA Orphan Designation provides CAN-3110 with certain developmental financial incentives, with potential for up to 7 years of marketing exclusivity in the United States, if approved.

CAN-3110, a next generation oncolytic viral immunotherapy, was previously granted Fast Track Designation by the FDA for the treatment of rHGG. Candel is currently evaluating CAN-3110 in a multi-institutional phase 1b clinical trial in rHGG.

The results from Arm A of the ongoing phase 1b clinical trial in rHGG exploring the clinical and biomarker activity of a single dose administration of CAN-3110 demonstrated a strong anti-tumoral response associated with extended survival.

The Company will present data on the feasibility and safety of multiple doses of CAN-3110 in patients with rHGG, supported by the Break Through Cancer Foundation, in a trials-in-progress poster presentation at the 2024 ASCO Annual Meeting.