Morphotek and Biocare Medical signed a collaboration and license agreement to develop and commercialize an immunohistochemical (IHC) diagnostic kit that combines Morphotek's human folate receptor alpha (FRA)-targeting monoclonal antibody with Biocare's intelliPATH™ automated stainer. Under terms of the deal, Biocare Medical gets a worldwide nonexclusive license to develop and commercialize an IHC kit for detecting human folate receptor alpha on FFPE tumor samples.
FRA is a tumor-expressed protein targeted by Morphotek's lead humanized IgG1 therapeutic antibody candidate, farletuzumab (MORAb-003). The mAb is currently undergoing Phase III development as combination therapy with platinum and taxane (P/T) in platinum-sensitive ovarian cancer subjects. FRA can be overexpressed by a number of epithelial-derived tumors including ovarian, breast, renal, lung, colorectal, and brain, but expression variability means that a diagnostic assay that can identify patients with FRA-positive cancers may enable more effective treatment decision making, the firms claim.
"We are excited to continue development of our first diagnostic product using a novel Morphotek antibody in cooperation with Biocare and their innovative IHC platform technology," remarks Daniel J. O'Shannessy, Ph.D., director of diagnostic development at Morphotek. "We believe that the development of a validated IHC assay (and subsequent submission to the FDA) will be a significant step forward for our drug development programs.”
Morphotek is an Eisai subsidiary focused on the development of therapeutic monoclonal antibodies for the treatment of cancer as well as inflammatory and infectious diseases. The firm has developed two technology platforms for antibody discovery that hinge on its morphogenics approach to the selective regulation of mismatch repair mechanisms for creating molecules with biologically and commercially attractive traits.
The human Morphodoma® technology employs an in vitro immunization process combined with morphogenics whole-genome evolution technology to yield target-specific antibodies targeting disease-associated antigens. The Libradoma™ platform generates libraries of hybridomas that can be rapidly screened to identify fully human monoclonal antibodies to known antigens and novel targets for both diagnostic and therapeutic applications. Morphotek says both the Morphodoma and Libradoma platforms result in antibodies that bypass the need to negotiate third party royalties required by alternative antibody technologies such as humanization, transgenic, and phage platforms.
Morphotek’s clinical pipeline is headed by farletuzumab. A second IgG1 antibody candidate, MORAb-004, is in early clinical development as a potential treatment for a range of cancers. MORAb-004 targets the cell surface protein endosialin (TEM1 or CD248), which is expressed on tumor-associated pericytes and other tumor stromal cells. The firm’s third anticancer candidate, MORAb-009 is an IgG1 antibody targeting the cell surface glycoprotein mesothelin, which is overexpressed on a number of cancers including pancreatic, ovarian, lung, and colorectal. The candidate is currently in Phase II development against pancreatic cancer and in early clinical development against mesothelioma. Morphotek’s preclinical pipeline includes antibody candidates targeting inflammatory diseases like rheumatoid arthritis and multiple sclerosis, along with anti-infective antibodies for potential defense applications. During mid-2010 the firm was granted Dutch authority clearance for a Phase I trial evaluating the antibody candidate MORAb-022 in rheumatoid arthritis patients.