Saturday, February 29, 2020
Harbour BioMed 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.”