Pharma Focus Asia

CAN-3110 Granted FDA Fast Track Status for Treating Recurrent High-Grade Glioma

Wednesday, February 14, 2024

Candel Therapeutics, Inc. (Candel), listed on Nasdaq under CADL, a clinical-stage biopharmaceutical company focusing on developing innovative multimodal biological immunotherapies for cancer treatment, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its CAN-3110 candidate. CAN-3110, a pioneering replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy, aims to enhance overall survival in patients with recurrent high-grade glioma (HGG).

Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, emphasized the significance of the FDA's Fast Track Designation for CAN-3110, highlighting the urgent need for effective treatments for recurrent HGG. Tak expressed confidence in CAN-3110's potential to address the shortcomings of existing standard of care and conventional therapies. He cited recent findings published in Nature, indicating promising outcomes, including a robust local and systemic anti-tumoral response and improved survival rates, following a single injection of CAN-3110. Additionally, he anticipated the release of further data, including the potential benefits of multiple injections of CAN-3110, from an ongoing phase 1b clinical trial in the latter half of 2024.

The announcement builds upon earlier research collaboration between Candel and Brigham and Women’s Hospital, where results from the ongoing phase 1b clinical trial were published in Nature in October 2023. These findings demonstrated CAN-3110's favorable safety profile and its ability to significantly extend median overall survival (mOS), surpassing historical survival rates for recurrent HGG. Notably, positive HSV-1 serology correlated with improved responses and increased survival rates.

Antonio Chiocca, MD, PhD, Head of Department of Neurosurgery at Brigham and Women’s Hospital and Principal Investigator, underscored the urgent need for effective treatments for recurrent HGG and expressed optimism about the potential of CAN-3110, especially with the FDA's Fast Track Designation, which could expedite its development and availability to patients.

CAN-3110, designed to selectively target cancer cells expressing Nestin, represents a novel approach to cancer treatment. It is currently undergoing evaluation in a phase 1 investigator-sponsored clinical trial for recurrent HGG. The trial, led by E. Antonio Chiocca, MD, PhD, includes different arms exploring various dosing strategies and combinations to optimize therapeutic outcomes.

Fast Track Designation from the FDA is a recognition of CAN-3110's potential to address a critical unmet medical need. This designation may facilitate expedited regulatory review and development processes, enabling more rapid access to innovative treatments for patients with serious conditions like recurrent HGG.

Candel Therapeutics is committed to advancing its multimodal biological immunotherapy platforms, including CAN-2409 and CAN-3110, to provide personalized and effective treatment options for cancer patients. Through its enLIGHTEN™ Discovery Platform, the company continues to innovate and develop new viral immunotherapies for solid tumors, leveraging human biology and advanced analytics.



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