First fully human, heavy chain only antibody in human trials has shown potent activity in preclinical studies through differentiated mechanism of action

Cambridge, MA, Rotterdam, NL, Suzhou, CN – February 28, 2020 

Harbour BioMed (HBM) today announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application to begin clinical studies with HBM4003, its next generation anti-CTLA-4 antibody for the treatment of cancer. The U.S. study builds on an initial ongoing trial in Australia. The trial will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM4003 as a single agent in subjects with advanced solid tumors.

“The IND approval is an important next step in our global program to develop this exciting molecule,” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “In preclinical studies, HBM4003 demonstrated potent anti-tumor activity based on a differentiated mechanism of action and a favorable safety profile. HBM4003 is the first in a portfolio of mono- and bi-specific antibodies based on our patented, heavy chain only (HCAb) technology against various immuno-oncology and immunology targets that are advancing toward clinical trials.”

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice^®. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to CTLA-4^High T_reg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

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 oncology and immunology. 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^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies. 

For further information, please refer to www.harbourbiomed.com

Media and Investor Relations Contact:

Atul Deshpande, Ph.D., MBA

Chief Strategy Officer and Head, US Ops.

Phone: +1-908-210-3347

E-mail: atul.deshpande@harbourbiomed.com