Candel Therapeutics Announces Oral Presentation During the 5th Glioblastoma Drug Development Summit with Update on Phase 1b Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma

• The first cohort of patients were treated with multiple injections of CAN-3110 in the ongoing phase 1b clinical trial.
  
• The serial procedures were well tolerated without observed dose-limiting toxicity.
  
• A second cohort is being planned for enrollment in the ongoing phase 1b clinical trial of CAN-3110.
  

NEEDHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing and commercializing viral immunotherapies to help patients fight cancer, today announced the presentation of updated data from an ongoing phase 1b clinical trial of its herpes simplex virus-1 (HSV-1) replication-competent viral immunotherapy candidate, CAN-3110, in patients with rHGG that has recurred after standard of care (SoC) treatment. The data were presented today during the 5^th Glioblastoma Drug Development Summit in Boston, Massachusetts.

“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.”

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 (mOS) 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.