CAN-2409 + valacyclovir

CAN-2409 + valacyclovir is an investigational combination therapy for solid tumors, developed by Candel Therapeutics. CAN-2409 is a replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumor cells. Once inside the tumor, HSV-tk converts orally administered valacyclovir—a prodrug—into a toxic nucleotide analogue that selectively kills cancer cells. This process induces immunogenic cell death and exposes tumor antigens in an activated microenvironment, leading to an individualized systemic CD8+ T cell-mediated immune response against both injected and distant tumors (in situ vaccination). The regimen has demonstrated activity across multiple solid tumors including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), high-grade glioma, and prostate cancer. It has received FDA Fast Track and Orphan Drug Designation for certain indications[1][2][3][4][5][6][8].