Candel Therapeutics, Inc. (NASDAQ: CADL) stock experienced a remarkable surge in its value during the preceding trading session, escalating by a notable 280.95% to reach a concluding figure of $6.40. This substantial upswing in CADL stock ensued subsequent to the dissemination of encouraging interim findings from a clinical trial.
Candel Therapeutics (CADL) disclosed updated interim survival data derived from the ongoing randomized phase 2 clinical study of CAN-2409 coupled with valacyclovir (a prodrug), alongside standard chemoradiation treatment, trailed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC). Survival metrics were revisited with an additional eight months of monitoring subsequent to the initial analysis, which was presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting.
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Following the data unveiling at SITC, the U.S. Food and Drug Administration (FDA) bestowed Fast Track Designation upon the Company for CAN-2409 combined with valacyclovir for addressing patients afflicted with PDAC in December 2023. Previously conducted evaluations of blood samples and excised tumors demonstrated consistent and potent activation of the immune system post-experimental treatment with CAN-2409.
Within pancreatic tissues of patients subjected to CAN-2409 alongside the prodrug and standard chemoradiation, dense clusters of CD8+ granzyme B positive cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were evident in the tumor microenvironment. Elevated concentrations of soluble granzymes B and H, along with pro-inflammatory cytokines, such as IFN-γ, were detected in peripheral blood subsequent to the administration of CAN-2409, contrasting with the standard of care regimen.
In light of the frequent relapses and limited survival outcomes associated with standard chemotherapy for non-metastatic PDAC, the imperative for effective novel therapeutic avenues is pressing. The enhanced survival prospects linked with CAN-2409 have exhibited enduring efficacy upon extensive follow-up, as evidenced by the updated data furnished in this randomized clinical investigation.
CAN-2409 demonstrated generally favorable tolerability without significant increments in local or systemic toxicity when integrated into the standard chemoradiation protocol. The inadequacy of traditional immunotherapeutic modalities in ameliorating outcomes in pancreatic cancer is ascribed to the profoundly immunosuppressive tumor microenvironment, which predominantly lacks immune cell infiltration.
The immunological alterations induced by CAN-2409, manifested in both pancreatic tissues and peripheral blood post-administration, indicate the capacity of CAN-2409 to modulate the equilibrium between the tumor and the patient’s anti-tumor immune response, thereby potentially transforming progressive cancer into a manageable chronic condition characterized by improved survival rates.
