On February 28, 2020 Harbour BioMed (HBM) reported 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 (Press release, Harbour BioMed, FEB 28, 2020, View Source [SID1234555002]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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-4High Treg 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.