NDV-ADC01-exatecan

NDV-ADC01-exatecan is a novel T-cell receptor-mimic antibody-drug conjugate (TCRm-ADC) designed to target the intracellular KRAS G12D mutation. It specifically recognizes the KRAS G12D peptide complexed with the HLA-A*11 major histocompatibility complex (MHC) on the surface of tumor cells. The conjugate consists of a high-affinity TCR-mimic antibody linked to exatecan, a potent DNA topoisomerase I inhibitor. By targeting the peptide-MHC (pMHC) complex, NDV-ADC01-exatecan enables the therapeutic targeting of an intracellular oncogene that is traditionally considered undruggable by standard antibody therapies. Preclinical data in lung, pancreatic, and colorectal cancer models have demonstrated significant antitumor efficacy and a favorable safety profile, with enhanced activity observed when combined with low-dose radiotherapy.