Immunomedics Reports Advances in Cancer Therapy

Preclinical Results of Two Products Presented at the 49th Annual Meeting of American Society of Hematology (ASH)


ATLANTA, Dec. 10, 2007 (PRIME NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported that results from two preclinical studies indicating that the Company's proprietary product candidates improve the therapy of cancer compared to certain established treatments. These results were presented at the 49th annual meeting of ASH in Atlanta, GA.

Milatuzumab, a humanized anti-CD74 antibody currently in a Phase I study for the treatment of multiple myeloma, was the subject of the first poster presentation. The ability of milatuzumab to increase the efficacy of doxorubicin, dexamethasone and bortezomib, used clinically to treat multiple myeloma, was examined both in vitro and in vivo. Crosslinked milatuzumab, when used together with each of the three multiple myeloma drugs, enhanced their effectiveness in inhibiting the growth of all four human multiple myeloma cell lines tested. In an animal model of human multiple myeloma, bortezomib alone increased the median survival time (MST) from 33 days in untreated animals to 44 days. Milatuzumab alone more than doubled the MST to 73 days. However, when bortezomib and milatuzumab treatment were combined, the MST increased to 93 days. "The inhibition of the NF-KB survival pathway of B-leukemic cells by milatuzumab supports its complementary effects when combined with drugs having different mechanisms of action, such as bortezomib," concluded Rhona Stein, Ph.D., of the Garden State Cancer Center in Belleville, NJ, principal investigator of the study.

The second poster presentation involved a bispecific antibody, TF4, created using the Company's proprietary Dock and Lock platform technology for protein engineering. TF4 is generated by linking two copies of the veltuzumab humanized anti-CD20 antibody fragment to a single fragment from a humanized anti-histamine-succinyl-glycine (HSG) antibody. Accordingly, this bispecific antibody binds divalently to CD20, with monovalent binding to a unique peptide hapten (HSG) carrying a therapeutic or diagnostic radionuclide. The objective of the current studies was to examine TF4 as a reagent for pretargeted therapy of B-cell lymphoma. The advantage of a pretargeting method is to separate the slow antibody-targeting step from the rapid radionuclide step. A bispecific construct with anti-tumor targeting ability such as TF4 accumulates at the site of tumor. After an appropriate period of time when the construct has cleared sufficiently from normal tissues and blood, the radiolabeled HSG peptide is administered and quickly captured by the tumor-targeted bispecific antibody. Unbounded hapten-peptide is rapidly excreted in the urine due to its low molecular weight. In an animal model of human B-cell lymphomas, pretargeting with TF4 resulted in significantly improved response rates, with durable cures and without the excessive hematologic toxicity commonly associated with directly radiolabeled antibodies. "This proof-of-principle preclinical study suggests that pretargeted radioimmunotherapy is more potent than radioimmunotherapy with antibodies directly-conjugated with therapeutic radionuclides," commented Immunomedics' President and CEO, Cynthia L. Sullivan.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us 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 highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We have exclusively licensed our lead product candidate, epratuzumab, to UCB (www.ucb-group.com) for the treatment of all autoimmune disease indications worldwide. Epratuzumab's most advanced program is for the treatment of systemic lupus erythematosus (SLE). At present, there is no cure for lupus and no new lupus drug has been approved in the U.S. in the last 40 years. We have retained the rights for epratuzumab in oncology indications for which UCB has been granted a buy-in option. The Company is conducting clinical trials with veltuzumab in patients with non-Hodgkin's lymphoma, epratuzumab as a potential therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer therapy and milatuzumab as a therapy for patients with multiple myeloma. We believe that our portfolio of intellectual property, which includes approximately 108 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. For additional information on us, please visit our web site at http://www.immunomedics.com. The information on our website does not, however, form a part of this press release.

This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partner for the further development of epratuzumab for autoimmune indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.



            

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