ALX001

ALX001 is a humanized bispecific antibody (bsAb) developed by Shanghai Ailux Biotechnology for the treatment of immune-mediated inflammatory diseases (IMIDs), such as inflammatory bowel disease and psoriasis. It is engineered in a symmetric "2 + 2" format to concurrently target and neutralize two key inflammatory cytokines: tumor necrosis factor-like ligand 1A (TL1A) and interleukin-23 (IL-23). ALX001 binds TL1A with high affinity, specifically blocking its interaction with the signaling receptor DR3 while sparing the decoy receptor DcR3, and also potently inhibits IL-23 signaling. Preclinical studies have demonstrated that dual inhibition of these pathways yields synergistic effects, reducing Th1/Th17 differentiation, fibroblast activation, and mucosal cytokine levels. ALX001 has shown superior efficacy compared to monoclonal antibody monotherapies in animal models of colitis and psoriasis and possesses a favorable pharmacokinetic profile in non-human primates.