arGEN-X initiates Phase Ib study of ARGX-110 in cancer
January 7 2013, Breda, the Netherlands, and Ghent, Belgium – arGEN-X announced today the initiation of a Phase Ib first-in-man cancer study with ARGX-110, its first SIMPLE Antibody™ program to enter the clinic in just three years from initiation of discovery.
ARGX-110 is a first-in-class CD70-targeting monoclonal antibody that addresses both known mechanisms of action mediated by CD70: tumor cell proliferation and survival and tumor cell escape from immune surveillance. In addition, POTELLIGENT® enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) of ARGX-110 drives the selective destruction of CD70 positive tumor cells. The Phase Ib study will utilize a validated immunohistochemistry test to pre-screen patients for those whose tumors show up-regulation of CD70.
“CD70 expression is hijacked by cancer cells to stimulate their own growth and escape the body’s immune surveillance. With ARGX-110 we are focusing on treating both the tumor and its immune environment with one molecule,” said Alain Thibault, M.D., Chief Medical Officer at arGEN-X. “ARGX-110 is an excellent example of how our proprietary antibody discovery technologies can create exciting development candidates with unique and novel modes of action in cancer. We look forward to the results from this study and to further progress with this and other antibodies in our pipeline during the next 12 months.”
In preclinical testing, ARGX-110 has shown broad therapeutic potential against CD70 positive lymphomas and lymphocytic leukemias, as well as solid tumors including those caused by oncogenic viruses, such as nasopharyngeal, cervical, and hepatocellular carcinomas. For Ahmad Awada, MD, PhD of the Jules Bordet institute and principal investigator of this trial, “CD70 may be a unifying driver mechanism for different subsets of cancer that are still poorly understood.”
The Phase Ib study being undertaken by arGEN-X is an adaptive dose escalation with safety expansion trial in around 54 patients, to be conducted by a consortium of leading academic institutions in Belgium. In addition to traditional clinical and PK endpoints, biomarkers critical to understanding CD70 biology will be researched extensively in the course of the trial. Results on the recommended dose for future pivotal trials are expected by end Q4, 2013.