Candel Therapeutics announces interim data from Phase 2 trial of CAN-2409

Candel Therapeutics announced updated interim survival data from the ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir together with standard of care chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma. Survival data were updated with eight months of further follow-up since the first analysis presented at the 2023 Society for Immunotherapy Annual Meeting. Based on the data presented at SITC, the U.S. Food and Drug Administration granted Fast Track Designation to the Company for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC in December 2023. Data Highlights as of a March 29, 2024 Data Cut-off, Include: Prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable PDAC; Estimated median overall survival was 28.8 months in the CAN-2409 group versus only 12.5 months in the control group. At 24 months, a survival rate of 71.4% was observed in CAN-2409 treated patients, after SoC chemoradiation and prior to surgery, versus only 16.7% in the control group. At 36 months, a survival rate of 47.6% was estimated in patients who received CAN-2409, together with SoC chemoradiation prior to surgery, versus only 16.7% in the control group. Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients, randomized to control SoC chemotherapy, remained alive at data cut-off. Previous analysis of blood and resected tumors showed consistent and robust activation of the immune response after experimental treatment with CAN-2409; In pancreatic tissue of patients treated with CAN-2409 plus prodrug together with SoC, dense aggregates of CD8+ granzyme B positive cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were observed in the tumor microenvironment. Increased levels of soluble granzymes B and H, as well as pro-inflammatory cytokines, including IFN-gamma, were observed in peripheral blood after CAN-2409 administration, but not after SoC. CAN-2409 continued to be associated with a favorable safety/tolerability profile; Addition of CAN-2409 regimen to SoC was generally well tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.