A clinical-stage biopharmaceutical company has been granted Fast Track Designation by the FDA for a first-in-class drug candidate.
Focused on developing multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. CADL was granted the designation for CAN-3110, a replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate for patients with recurrent high-grade glioma (HGG). The Needham, Mass.-based company hopes CAN-3110 will improve overall survival in this patient population.
A phase 1b clinical trial of CAN-3110 in recurrent HGG, led by E. Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at Brigham & Women’s Hospital and Professor at Harvard Medical School, is ongoing. Candel Therapeutics plans to report additional data, including the potential benefits from multiple injections of CAN-3110, from the clinical trial in the second half of 2024.
Designed to facilitate the development and expedite the review of medicines that can treat serious conditions, Fast Track Designation offers an investigational medicine eligibility for more frequent interactions with the FDA to discuss the candidate’s development plan. The medicine may be eligible for priority review if relevant criteria are met.
“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. “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 in the Phase 1b trial.”
Additionally, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in the high-impact journal Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a near-doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of about 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; the mOS in this population reached 14 months. 50 to 80% of American adults have oral herpes (HSV-1), which causes cold sores or fever blisters near or in the mouth. Caused by HSV-1 or HSV-2, genital herpes affects one out of every six people in the U.S. aged 14 to 49.
Furthermore, 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.
“Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” Chiocca, the study director, said. “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.”
In December 2023, Candel Therapeutics also received Fast Track Designation for both non-small cell lung cancer (NSCLC) and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, its most advanced product candidate. An investigational viral immunotherapy, CAN-2409 is designed to stimulate an individualized, systemic immune response to the patient’s specific tumor. CAN-2409 plus valacyclovir in combination with continued PD-1/PD-L1 agents is being evaluated in an ongoing, open-label phase 2 clinical trial in patients with late-stage NSCLC.
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