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

Candel Therapeutics announced initial positive interim survival and immunological biomarker 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. Data were presented today in a poster session titled ‘Neoadjuvant CAN-2409+Prodrug Plus Chemoradiation for Borderline Resectable or Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma at the 2023 Society for Immunotherapy Annual Meeting. Data Highlights as of August 21, 2023 Data Cutoff, include: Prolonged and sustained survival was observed after experimental treatment with CAN-2409 plus prodrug in patients with borderline resectable PDAC; An estimated survival rate of 71.4% at both 24 and 36 months, observed in patients who received CAN-2409 regimen together with SoC chemoradiation prior to surgery, versus only 16.7% survival at 24 and 36 months in patients with SoC chemoradiation prior to surgery.; Importantly, 5 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with two patients surviving more than 45 months from enrollment. Only one patient randomized to control SoC chemotherapy remained alive at data cut-off; Median overall survival has not yet been reached in patients who received CAN-2409; median overall survival was 12.5 months in the control arm. Disease course was altered after salvage chemotherapy with improved CA19-9 levels and ongoing survival in CAN-2409 arm, but not in control arm. Data showed consistent and robust activation of immune response after dosing 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 T cells, 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 treatment, but not with control treatment. CAN-2409 was associated with a favorable tolerability profile; Addition of CAN-2409 regimen to SoC was generally well tolerated, with no reported dose-limiting toxicities, including no cases of pancreatitis.