Candel Therapeutics “announced the presentation of updated data from an ongoing phase 1b clinical trial of its herpes simplex virus-1 replication-competent viral immunotherapy candidate, CAN-3110, in patients with rHGG that has recurred after standard of care treatment. The data were presented today during the 5th Glioblastoma Drug Development Summit in Boston, Massachusetts. To date, over 50 patients have been treated with a single dose of CAN-3110 in the phase 1b clinical trial of CAN-3110 in recurrent high-grade glioma (rHGG). The investigators observed a nearly doubling of the expected median overall survival 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). Results from the ongoing phase 1b clinical trial were published in Nature in Q4 2023. CAN-3110 received U.S. Food and Drug Administration (FDA) Fast Track Designation for treatment of rHGG in Q1 2024, based on these data.” “We have recently reported encouraging clinical and biomarker activity data observed after a single dose of CAN-3110 in patients with rHGG. We observed a nearly doubling of the expected median overall survival in this therapy-resistant patient population,” said Francesca Barone, MD, PhD, Chief Scientific Officer of Candel. “The data presented today further supports that repeated doses of CAN-3110 are feasible and generally well-tolerated in rHGG, potentially further improving the clinical activity of this investigational medicine. Safety and tolerability of both repeated injections and serial biopsies, performed prior to the administration of CAN-3110, will be monitored to gauge disease progression and tissue response to treatment. We look forward to sharing additional biomarker and clinical activity data in the second half of this year.”
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