Morphotek® was granted orphan drug status for MORAb-009, a Mab against pancreatic cancer. MORAb-009 is an antibody that recognizes mesothelin, a cell surface glycoprotein over-expressed in a number of cancers.
Researchers at the NCI and Johns Hopkins University independently validated the association of this protein in cancer and the therapeutic potential of drugs that can specifically target it, says Morphotek. Studies have demonstrated a high correlation of mesothelin expression with pancreatic, mesothelioma, ovarian, and non-small-cell-lung carcinomas, as well as several epithelial-based cancers.
In December 2005, Morphotek signed an exclusive worldwide patent license agreement with the NCI giving it the right to develop and commercialize MORAb-009 and its molecular variants for the diagnosis and treatment of mesothelin-expressing tumors. There are six issued patents and two provisional patent applications that cover the antigen target and use of MORAb-009 antibodies for therapy.
MORAb-009 will initially be developed for cancer. The first Phase I study is designed to evaluate MORAb-009 in subjects with pancreatic cancer mesothelioma and certain types of ovarian and lung cancers.