Candel Therapeutics earns FDA fast track status for recurrent high-grade glioma treatment

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Fda Food and drug administration Cancer Oncology

The US FDA has granted fast track designation to CAN-3110, a viral immunotherapy candidate from Candel Therapeutics to treat patients with recurrent high-grade glioma (HGG) and improve overall survival.

In October 2023, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported.

In addition, median overall survival (mOS) doubled after a single injection of CAN-3110, rising to 12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition.

“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, 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.”

The company is currently evaluating the effects of multiple CAN-3110 injections in recurrent HGG, supported by the Break Through Cancer Foundation, and expects early results in the second half of 2024.

“Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” said Antonio Chiocca, head of department of neurosurgery at Brigham and Women’s Hospital and principal investigator.

“With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.”

The news comes after Candel previously received FDA fast track designation for its pancreatic cancer treatment​ CAN-2409, with updated overall survival data from a phase 2 clinical trial expected in the second quarter of this year. 

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