HBM HOLDINGS-B Receives FDA Clearance for HBM7004 Investigational New Drug Application

Stock News05-08

HBM HOLDINGS-B (02142) has announced that its Investigational New Drug (IND) application for HBM7004 has been approved by the U.S. Food and Drug Administration (FDA). The company will initiate a first-in-human Phase I clinical trial of the novel B7H4xCD3 bispecific antibody in the United States. This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary anti-tumor activity of HBM7004 in patients with advanced solid tumors.

HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the group's proprietary HBICE® platform, offering a differentiated solution for cancer immunotherapy from both efficacy and safety perspectives. The development of HBM7004 further highlights the flexible applicability and plug-and-play advantages of the HBICE® platform. In preclinical studies, HBM7004 demonstrated a B7H4-dependent T-cell activation mechanism within tumors. In various animal model experiments, the candidate exhibited potent anti-tumor effects, excellent in vivo stability, and low systemic toxicity.

Furthermore, in preclinical models, HBM7004 showed strong synergistic effects when combined with a B7H4x4-1BB bispecific antibody under conditions of low effector-to-target cell ratios, indicating a promising therapeutic window.

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