HBM Holdings Limited announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for HBM7004, allowing the company to launch a first-in-human Phase I clinical trial in the United States.

The upcoming Phase I study will evaluate safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HBM7004 in patients with advanced solid tumors.

HBM7004 is a novel B7H4xCD3 bispecific antibody generated via the company’s proprietary HBICE platform. Preclinical studies demonstrated tumor-specific, B7H4-dependent T-cell activation, robust anti-tumor efficacy, high in-vivo stability and reduced systemic toxicity. In addition, preclinical data indicated a strong synergistic effect when HBM7004 was combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, suggesting an encouraging therapeutic window.

The company cautioned that successful development and commercialization of HBM7004 are not guaranteed.