Chinese biopharmaceutical company Harbour BioMed (HKEX:02142) announced on Friday that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HBM7004, enabling the initiation of a first-in-human Phase I clinical trial.

The study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumour activity of HBM7004 in subjects with advanced solid tumours.

HBM7004 is a novel B7H4xCD3 bispecific antibody developed using Harbour BioMed's HBICE platform. It is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety.

In preclinical studies, HBM7004 demonstrated an intratumour B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumour efficacy, in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window.