Harbour BioMed Announces IND Clearance for HBM9027 in the U.S.

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 23, 2024 /PRNewswire/ — Harbour BioMed (the “Company”, HKEX: 02142) announced that the Company has been granted the clearance of Investigational New Drug (IND) from the Food and Drug Administration (FDA) of the United States to initiate the first-in-human (FIH) clinical trial in the U.S. for bispecific antibody HBM9027. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9027 in subjects with advanced solid tumors.

HBM9027 is generated from Harbour BioMed’s proprietary fully human HBICE® platform. It is a novel PD-L1xCD40 bispecific antibody, which is designed to activate CD40 relied on PD-L1 crosslinking for a promising safety profile. PD-L1 is overexpressed on a variety of solid malignancies, and with its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM9027 has shown excellent and promising safety profile with strong anti-tumor efficacy in its pre-clinical studies.

“HBM9027, developed through our proprietary HBICE® platform, has demonstrated a promising safety profile and robust anti-tumor efficacy,” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “This achievement highlights the capability of our technology platform in developing novel solutions for advanced solid tumors. We firmly believe that our unweaving commitment to innovation will bring about meaningful advancements in cancer treatment.”

About HBM9027

HBM9027 is a novel PD-L1xCD40 bispecific antibody, developed using the HBICE® bispecific technology and Harbour Mice® Platform. The development of PD-L1xCD40 bispecific HBICE® further expands the Company’s bispecific immune cell engager into the cutting-edge DC/myeloid cell engager field and demonstrates HBICE® platform’s versatile geometry formats and plug-and-play advantages.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions.

The Company’s proprietary antibody technology platforms Harbour Mice® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) are capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, HBICE® with single B cell cloning platform, the antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.

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SOURCE Harbour BioMed