The US Food and Drug Administration (FDA) has granted orphan drug designations to Eisai subsidiary Morphotek's two investigational cancer drugs - MORAb-004 to treat soft tissue sarcoma and MORAb-066 to treat pancreatic cancer.
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MORAb-004 is a humanized monoclonal antibody to endosialin/tumor endothelial marker-1 (TEM-1), which is a protein that is expressed in many human malignancies, and which plays a role in tumor development.
MORAb-004 binds to TEM-1, and has demonstrated antitumor activity in a variety of nonclinical models.
MORAb-066 is a humanized monoclonal antibody to tissue factor, which is a protein that plays an important role in blood coagulation.
Morphotek develops protein and antibody products through the use of a gene evolution technology.
The technology is applied to 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.
Morphotek president and CEO Nicholas Nicolaides said they believe that working toward treating disease is essential to achieve human health care mission to patients and their families and to increase the benefits to health care provides.
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