Harbour BioMed Bags US FDA Nod For Bispecific Antibody

Harbour BioMed, a worldwide biopharmaceutical business, announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to start the first-in-human (FIH) clinical study in the US for bispecific antibody HBM9027. This is a phase I trial to assess HBM9027's safety, tolerability, pharmacokinetics, and anti-tumor activity in patients 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 tumours and potent immune modulation activity, HBM9027 has shown excellent and promising safety profile with strong anti-tumour efficacy in its pre-clinical studies, as per pharmabiz.

“HBM9027, developed through our proprietary HBICE platform, has demonstrated a promising safety profile and robust anti-tumour 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 tumours. We firmly believe that our unweaving commitment to innovation will bring about meaningful advancements in cancer treatment.”

HBM9027 is a new PD-L1xCD40 bispecific antibody created with the HBICE bispecific technology and the Harbour Mice Platform. The creation of PD-L1xCD40 bispecific HBICE extends the Company's bispecific immune cell engager into the cutting-edge DC/myeloid cell engager sector, demonstrating the HBICE platform's various geometrical formats and plug-and-play benefits.

Harbour BioMed is a global biopharmaceutical business dedicated on the research, development, and commercialization of new antibody therapies for immunology and oncology.