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 - Seite 2

“Dosing patients with multiple injections represents the next step forward in the development of CAN-3110 for rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “The observed data suggest that repeated injections of CAN-3110 are well tolerated, supporting the design of a future phase 2 clinical trial in this indication. We’re excited by our recent progress -- as illustrated by the publication in Nature, CAN-3110’s recent FDA Fast Track designation, and the collaboration with Batavia Biosciences -- to accelerate the development and production of CAN-3110, along with our update presented today. Together, we hope this will help to accelerate the development of a better treatment for patients with high unmet need.”

About the phase 1 clinical trial of CAN-3110 in rHGG

The clinical trial comprises three arms. In arm A, 41 patients with recurrent HGG received a single intratumoral injection of CAN-3110 (dose ranging from 1x10⁶ plaque forming units (pfu) to 1x10¹⁰ pfu), including nine patients with multifocal/multicentric, deep or bilateral tumors associated with poor survival. After observing this regimen was generally well tolerated without dose-limiting toxicity, patients in arm B (n=9) received a single dose of cyclophosphamide (24 mg/kg) two days before CAN-3110 injection at doses of 1 x 10⁸ pfu (n=3) and 1 x 10⁹ pfu (n=6). The rationale is based on findings in mouse models, where cyclophosphamide improved viral persistence in injected tumors. In arm C, two cohorts of 12 patients with rHGG will receive up to six injections of CAN-3110 over a four-month period.

About CAN-3110

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1 investigator-sponsored clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported and CAN-3110 plus prodrug was associated with improved survival. Positive HSV-1 serology was a predictor of response and was associated with improved survival. Increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were also associated with improved survival. In the clinical trial, the investigators observed a nearly doubling of the expected median overall survival after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. By comparison, survival in the anti-HSV1 positive patients who received CAN-3110 was more than 14 months.