ALE-C04

ALE-C04 is a first-in-class monoclonal antibody developed by Alentis Therapeutics that specifically targets exposed Claudin-1 (CLDN1) on cancer cells. Unlike normal tissues where CLDN1 is sequestered within tight junctions, certain tumors exhibit exposed CLDN1, making it a highly selective target. ALE-C04 works through a dual mechanism: it remodels the extracellular matrix to improve the trafficking of natural killer (NK) and T-cells into the tumor microenvironment and directly kills tumor cells through its effector functions. The drug is primarily being investigated for the treatment of CLDN1-positive tumors, particularly head and neck squamous cell carcinoma (HNSCC). It has received FDA Fast Track designation for recurrent or metastatic CLDN1-positive HNSCC and is currently undergoing evaluation in Phase 1/2 clinical trials both as a monotherapy and in combination with PD-1 inhibitors.