Candel Therapeutics announces CAN-3110 received U.S. FDA FTD

Candel Therapeutics announced that the U.S. Food and Drug Administration, FDA, granted Fast Track Designation, FTD, for CAN-3110 — a first-in-class, replication-competent herpes simplex virus-1 oncolytic viral immunotherapy candidate – for the treatment of patients with recurrent high-grade glioma to improve overall survival. “Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “As recently published in Nature, a strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110. We look forward to reporting additional data, including the potential benefits from multiple injections of CAN-3110, from the ongoing phase 1b clinical trial in the second half of 2024.”