Morphotek, Inc., a subsidiary of Eisai Inc., announced that it has commenced a multi-centre, phase II study of MORAb-004 for the treatment of metastatic melanoma. The study will evaluate MORAb-004, a potentially first-in-class monoclonal antibody that specifically binds to endosialin/Tumour Endothelial Marker-1 (TEM-1), as a single agent therapy comparing its safety and therapeutic activity at two dosages.
The trial is designed as an open-label study to assess the efficacy of single agent MORAb-004 at one of two doses as determined by progression-free survival in patients with metastatic melanoma. Secondary objectives include assessment of an overall survival benefit, identification of an optimal dose, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004. The patient population includes individuals with metastatic melanoma who have received at least one previous drug regimen. It is estimated that nearly all metastatic melanoma tumours are endosialin/TEM-1 positive.
Morphotek expects to enroll up to 80 patients in this study, which is being conducted at clinical centres in the United States, Europe and Australia. As part of the trial, patient tumours 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.
“We are excited to have initiated this phase II study of MORAb-004 in melanoma,” stated Christina Coughlin, MD, PhD, senior director of Clinical Development at Morphotek. “New agents are needed for the treatment of metastatic melanoma which remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several of the world’s 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).
Morphotek, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications.
Eisai Inc. focusses on neurology, gastrointestinal disorders and oncology/critical care.