Harbour Biomed received IND clearance from the FDA for HBM-7004, enabling initiation of a first-in-human Phase I trial in advanced solid tumors. HBM-7004 is described as a B7H4 x CD3 bispecific antibody built on Harbour Biomed’s HBICE platform, with preclinical data indicating intratumor, B7H4-dependent T-cell activation. The company said the IND clears the way to enroll subjects later, setting up an early test of the therapeutic’s safety and initial biologic activity profile in a population with limited options. The clearance also expands Harbour Biomed’s clinical pipeline around immune targeting strategies designed to redirect T-cell activity within tumor sites. For investors and partners, FDA IND clearance typically shortens the gap between preclinical signal and dose-escalation data, which can be decisive for next funding and licensing discussions.