Harbour BioMed Announces U.S. FDA Approval of IND for Its Next Generation anti-CTLA-4 Antibody, HBM4003, to Treat Cancer

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

CAMBRIDGE, Mass. & ROTTERDAM, Netherlands & SUZHOU, China--(BUSINESS WIRE)--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 is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.

The company's internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice^®) for generating both fully human monoclonal antibodies and heavy chain only antibodies (HCAb) based immune cell engager (HBICE™) bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China.