On January 23, 2024 Harbour BioMed (the "Company", HKEX: 02142) reported 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 (Press release, Harbour BioMed, JAN 23, 2024, View Source [SID1234639434]). This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9027 in subjects with advanced solid tumors.

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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.