
DEM301 is a clinical development candidate, an antibody-drug conjugate (ADC) composed of an afucosylated monoclonal antibody (targeting DEM-TXX), conjugated to clinically validated linker-payload. DEM BioPharma is currently evaluating DEM301 in pre-clinical pharmacology and toxicology studies and has initiated DEM301 CMC process development and manufacturing in anticipation of Investigational New Drug Application Mid 2026.
DEM-TXX is a novel plasma membrane-associated glycoprotein, primarily found on mucosal epithelial cells. Identified as a 'DEM' signal in a CRISPRa screen of tumor cells, it has been reported to play roles in cell adhesion and myeloid cell suppression. DEM-TXX is notably overexpressed in colorectal, gastric, liver, pancreatic, cervical, and testicular cancers and has been associated with malignant phenotypes in multiple solid tumors. Its expression is negatively correlated with disease progression, underscoring its potential significance in tumor biology.