Morphotek, Inc., a subsidiary of Eisai Inc., a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology, has commenced a multi-centre, phase II study evaluating the safety and efficacy of MORAb-004 in the treatment of metastatic colorectal cancer that is refractory to all standard therapy. MORAb-004 is a monoclonal antibody that specifically binds to endosialin/tumour endothelial marker-1 (TEM-1).

The trial is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of single agent MORAb-004 plus best supportive care as determined by progression-free survival in patients with chemorefractory metastatic colorectal cancer. Secondary objectives include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004.

Morphotek expects to enroll up to 160 patients in this study, which is being conducted at clinical centres in the United States.  As part of the trial, patient tumors and plasma samples will be tested for endosialin/TEM-1 and/or proteins within its pathway to determine if the pattern of expression relates to or determines clinical effect. The goal of these investigations is to identify those patients who had a clinically meaningful response to MORAb-004.

"We are excited to have initiated this phase II study of MORAb-004 in metastatic colorectal cancer," stated Christina Coughlin, M.D., Ph.D., senior director of clinical development at Morphotek. “New agents are needed for the treatment of metastatic colorectal cancer.  The treatment of chemorefractory colorectal cancer remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several key experts in this disease setting.”

MORAb-004 is a humanized monoclonal antibody specific for endosialin/TEM-1 protein.  The target is found to be expressed on the cell surface of cells called pericytes that are part of the tumour blood vessel architecture, as well as on fibroblast cells that are part of the tumour stroma.  Morphotek obtained exclusive worldwide rights to develop and commercialize this antibody from the Ludwig Institute for Cancer Research (LICR).