Harbour BioMed announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the B7H4x4-1BB bispecific antibody (HBM7008), which has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia in May 2022 and received an IND approval from China National Medical Products Administration in early June 2022. HBM7008 is generated from HBM's unique and innovative HBICE® platform. It is a first-in-class bispecific antibody targeting B7H4 and 4-1BB.

The bispecific antibody can engage and activate T cells by 4-1BB only in B7H4 positive tumor microenvironment. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking-dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown an excellent safety profile with strong anti-tumor efficacy in pre-clinical studies.