Harbour Biomed received FDA IND clearance for HBM-7004, enabling first-in-human evaluation of the company’s B7H4 x CD3 bispecific antibody. The program is expected to start a Phase I trial in subjects with advanced solid tumors during the second half of the year. HBM-7004 was built using Harbour Biomed’s HBICE platform, and preclinical work reported intratumor B7H4-dependent T-cell activation. As a bispecific concept, it targets tumor-associated immunosuppression signals while recruiting T cells directly into the tumor microenvironment. For investors and development teams, IND clearance is a key gating milestone that allows dosing initiation, endpoint planning, and site activation. It also adds to the expanding set of bispecifics aiming to reduce TME-driven immune escape.