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|Immunomedics, Inc. was incorporated in Delaware in 1982. It is a biopharmaceutical company which is focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. It has developed advanced proprietary technologies that allow it to create humanized antibodies that can be used either alone in unlabeled or ‘naked’ form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, it has built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. It has exclusively licensed its product candidate, epratuzumab, to UCB S.A., or UCB, for the treatment of all non-cancer indications worldwide. Epratuzumab’s advanced clinical testing is for the treatment of systemic lupus erythematosus, or SLE (lupus), in non-Hodgkin lymphoma, or NHL and acute lymphoblastic leukemia, or ALL. During the 2012 fiscal year, it has completed a Phase I/II clinical trial evaluating clivatuzumab tetraxetan (hPAM4) labeled with yttrium-90, or Y-90, in combination with gemcitabine for treating patients with newly diagnosed advanced pancreatic cancer. It also initiated a randomized Phase Ib study examining the Y-90-labeled clivatuzumab tetraxetan, with and without low-dose gemcitabine, in pancreatic cancer patients who have received at least 2 prior therapies. It is also conducting a National Cancer Institute, or NCI, grant-supported study combining unlabeled veltuzumab with Y-90-labeled epratuzumab tetraxetan in patients with diffuse large B-cell lymphoma, or DLBCL, the aggressive form of NHL. In addition, milatuzumab and veltuzumab are currently being evaluated individually as a monotherapy for patients with chronic lymphocytic leukemia, or CLL, and in combination in NHL patients. Milatuzumab is also being studied as a conjugate with the potent chemotherapeutic, doxorubicin, in a dose-escalation study in patients with multiple myeloma (MM). Milatuzumab-doxorubicin is the first product candidate from its robust antibody-drug conjugate, or ADC, program to have entered into human testing. The second ADC in its product pipeline is, labetuzumab-SN-38, which is in a Phase I/II trial in patients with advanced colorectal cancer. In the first half of fiscal 2013, it plan to begin a new study examining the safety and tolerability of its third ADC, hRS7-SN-38, in patients with solid cancers, for which an Investigational New Drug (IND) application has been filed with the Food and Drug Administration (FDA). Its research and development activities, including testing in laboratory animals and in humans, its manufacture of antibodies, as well as the handling, labeling and storage of the product candidates that the company is developing, are all subject to stringent regulation, primarily by the FDA in the U.S. and by comparable authorities in other countries.|
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