CAN-3110 Receives FDA Fast Track Designation for Treatment of Recurrent High-Grade Glioma

NEEDHAM, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for CAN-3110 -- a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate – for the treatment of patients with recurrent high-grade glioma (HGG) 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.”

In October 2023, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a nearly doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of ~12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. Positive HSV-1 serology was a predictor of response and was associated with improved survival (mOS in this population reached 14 months). Increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after administration were also associated with improved survival, suggesting that CAN-3110 can elicit both a local and systemic antitumoral response.