Harbour BioMed (“the Company”; HKEX code 02142), a global biopharmaceutical company dedicated to the discovery and development of novel antibody therapeutics in the fields of immunology, oncology, and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for HBM7004, thereby initiating a first-in-human (FIH) Phase I clinical trial. This study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of HBM7004 in subjects with advanced solid tumors.

HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the company's HBICE® platform . This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy, potentially improving efficacy and safety. The development of HBM7004 further demonstrates the versatility and plug-and-play advantages of the HBICE® platform . In preclinical studies, HBM7004 exhibited a tumor-dependent B7H4-dependent T-cell activation pathway. In multiple animal models, HBM7004 demonstrated strong antitumor efficacy, significant in vivo stability, and reduced systemic toxicity. Furthermore, in preclinical models, HBM7004 exhibited a strong synergistic effect when bound to the B7H4x4-1BB bispecific antibody and at a low effector-to-target cell ratio, indicating an encouraging therapeutic window.

Dr. Jinsong Wang, Founder, Chairman and CEO of Harbour BioMed, stated, “The FDA’s IND approval of our B7H4xCD3 bispecific antibody, HBM7004, marks a significant step forward in advancing our innovative process for developing treatments for patients with advanced solid tumors.” “This project reflects our continued focus on developing differentiated biologic therapies, leveraging industry-leading proprietary platforms to address significant unmet needs in oncology. We are confident in the potential of HBM7004 and look forward to evaluating its clinical benefits in patients with advanced solid tumors.”

About Harbour Pharmaceuticals

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company dedicated to the discovery and development of novel antibody therapies in immunology, oncology, and other fields. The company has built a strong portfolio and a differentiated R&D pipeline through internal R&D capabilities, collaborative discovery and development through global strategic partnerships, and selective acquisitions.

The company's proprietary antibody technology platform, Harbour Mice® , can generate fully human monoclonal antibodies, supporting both traditional two-chain and two-light-chain (H2L2) formats, as well as heavy-chain-only (HCAb) forms. Based on HCAb antibodies, the HCAb-based immune cell activator (HBICE) ® bispecific antibody technology achieves tumor-killing effects unattainable by traditional combination therapies. The HCAb Plus technology (HCAb PLUS ™ ) provides a comprehensive solution for the development of innovative multispecific drugs across various disease areas. Furthermore, based on the Harbour Mice® platform , Harbour BioMed has launched the first fully human generative AI HCAb model, powered by the Hu-mAtrIx ™ AI platform, accelerating the development of innovative therapies.

By integrating Harbour Mice® , HBICE® , HCAb PLUS ™ , a single B-cell clone platform, and artificial intelligence technologies, Harbour BioMed has built a highly efficient and unique antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.
https://mp.weixin.qq.com/s/Cz8-srrTy3N5kmkeiudsGA