Profile: Immunomedics, Inc. (IMMU.O)

Immunomedics, Inc. (Immunomedics), incorporated in 1982, is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. The Company has developed a number of advanced 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 or toxins, in each case to create targeted agents. Immunomedics has licensed its product candidate epratuzumab, to UCB S.A. (UCB), for the treatment of all autoimmune disease indications worldwide. Epratuzumab’s most advanced clinical testing is for the treatment of systemic lupus erythematosus (SLE), and in non-Hodgkin’s lymphoma (NHL). The Company has retained the rights to epratuzumab in oncology indications, subject to UCB’s buy-in option, and is advancing trials in lymphoma and in childhood acute lymphoblastic leukemia (ALL), in cooperation with National Cancer Institute Study Groups. In addition, it has exclusively licensed its product candidate veltuzumab, in the subcutaneous formulation, to Nycomed GmbH (Nycomed), for the treatment of all non-cancer indications.

Immunomedics has retained the rights to develop, manufacture and commercialize veltuzumab in the field of oncology. It is conducting clinical trials with intravenous veltuzumab in patients with NHL and immune thrombocytopenic purpura (ITP) and chronic lymphocytic leukemia (CLL), 90Y-epratuzumab for the therapy of patients with lymphoma, 90Y-hPAM4 combined with gemcitabine for pancreatic cancer therapy, and its anti-CD74 antibody (milatuzumab) as a therapy for patients with multiple myeloma (MM), NHL, and CLL. The Company also has a majority ownership in IBC Pharmaceuticals, Inc., which is developing a Dock-and-Lock methodology (DNL), for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas), by antibody-based, pretargeting methods.

Therapeutic Product Candidates

The Company has antibody product candidates in clinical development targeting B-cell NHL, other B-cell mediated diseases and various solid tumors. All of its therapeutic product candidates are humanized antibodies. The Company’s therapeutic product candidate, epratuzumab, is a humanized antibody which targets CD22, an antigen found on the surface of B-lymphocytes, a type of white blood cells.

CD20 is an antigen that is expressed on B-lymphocytes. Biological therapy with monoclonal antibodies for NHL includes rituximab, a chimeric antibody comprised of one-third mouse and two-thirds human protein that binds to the CD20 antigen. The Company is conducting a study to evaluate veltuzumab’s efficacy in chronic immune thrombocytopenic purpura (ITP) at low doses. It has completed an open-label, multi-center, Phase II trial using the intravenous formulation in NHL.

Yttrium Y 90 clivatuzumab tetraxetan or hPAM4 labeled with Y-90, is the Company’s therapeutic product candidate for patients with pancreatic cancer. Yttrium Y 90 clivatuzumab tetraxetan has Orphan Drug status in both the United States and the European Union, and fast-track status in the United States for the treatment of pancreatic cancer. As of June 30, 2009, the Company’s study is a Phase Ib, open-label, dose escalation of yttrium Y90 clivatuzumab tetraxetan administered as fractioned, multi-doses, in combination with low-dose gemcitabine as frontline therapy for patients with Stage III or Stage IV metastatic pancreatic cancer.

CD74 is a transmembrane protein that is highly expressed in multiple myeloma and other B-cell lymphomas. It actively directs transport from the cell surface to an endosomal compartment and, as such, is a unique target for antibody-drug immunoconjugate therapy. As of June 30, 2009, Milatuzumab was in a Phase I/II multicenter clinical trials to evaluate its safety and tolerability in patients with multiple myeloma. The CD74 antibody conjugated with the cancer drug doxorubicin was in preclinical development as of June 30, 2009. Yttrium Y 90 epratuzumab tetraxetan is the Company’s radiolabeled CD22 antibody product candidate being evaluated in Europe in a Phase I/II study in patients with NHL. The Company has developed another solid tumor therapeutic product candidate that targets carcinoembryonic antigen (CEA) or CEACAM5, expressed by cancers of the colon, rectum, breast, lung and other solid tumors.

Other Antibody-Directed Therapy Approaches

The Company’s majority-owned subsidiary, IBC Pharmaceuticals, Inc. (IBC), has been working on the development of cancer radioimmunotherapeutics using pre-targeting technologies with bispecific antibodies. One of the new bispecific antibodies is TF2, an antibody constructed using its protein engineering platform technology, called DNL. F-18 FDG is a sugar analog approved for use in the United States for the detection of certain tumors, coronary artery disease and epilepsy. As of June 30, 2009, TF2 is in two investigator-sponsored studies in the United States and Europe for pretargeted imaging and radioimmunotherapy of colorectal cancer.

The Company competes with Biogen Idec, Genentech, Glaxo SmithKline, Hoffmann-LaRoche, Human Genome Sciences, Seattle Genetics, Trubion Pharmaceuticals, Zymogenetics, Merck Serono, Genmab, Medarex, Amgen Inc., Bristol-Myers Squibb, Bayer Schering Pharma AG, Pfizer, AstraZeneca and Eli Lilly.