NEEDHAM - Candel Therapeutics, Inc. (NASDAQ:CADL), a biopharmaceutical company specializing in biological immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its experimental drug CAN-3110 for the treatment of recurrent high-grade glioma (HGG), a particularly aggressive brain cancer. This designation aims to expedite the development and review of drugs intended to treat serious conditions and fill unmet medical needs.
The company's President and CEO, Paul Peter Tak, highlighted the importance of this development in addressing the challenges faced by standard care and conventional therapies in treating recurrent HGG. He mentioned that a single injection of CAN-3110 has shown promising results in improving survival rates, as published in the scientific journal Nature. The ongoing phase 1b clinical trial has demonstrated that CAN-3110 is well tolerated, with no dose-limiting toxicity, and is associated with a median overall survival (mOS) of approximately 12 months, nearly double the historical mOS of 6 to 9 months.
CAN-3110 is a first-in-class herpes simplex virus-1 (HSV-1) based oncolytic viral immunotherapy designed to target cancer cells expressing Nestin. The drug's dual mechanism is intended to cause direct oncolysis and activate the immune system. Positive HSV-1 serology was found to be a predictor of response, with improved survival rates in patients who tested positive for the virus.
Antonio Chiocca, MD, PhD, who leads the clinical trial at Brigham and Women's Hospital and is a professor at Harvard Medical School, expressed optimism that the Fast Track Designation would accelerate the development of CAN-3110 and potentially bring this new therapy to patients sooner.
Candel Therapeutics is also planning to initiate Investigational New Drug (IND)-enabling work for CAN-3110 in a second indication characterized by Nestin expression. Further data on the effects of multiple injections of CAN-3110 in recurrent HGG are expected in the second half of 2024.
The FDA's Fast Track Designation is part of a program that facilitates the development of new drugs that have the potential to address unmet medical needs in the treatment of serious conditions. This program allows for more frequent interactions with the FDA and, if relevant criteria are met, may qualify for priority review.
This news is based on a press release statement from Candel Therapeutics.
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