Epratuzumab Results in Lupus Presented at 2012 Annual European Congress of Rheumatology

| Source: Immunomedics, Inc.

BERLIN, June 8, 2012 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that data from preclinical and clinical studies of the new lupus drug candidate, epratuzumab – a humanized anti-CD22 antibody, will be presented at the 2012 annual Congress of the European League Against Rheumatism (EULAR) in Berlin, Germany. Our partner, UCB, is evaluating epratuzumab in two randomized, double blind, placebo-controlled Phase III EMBODY™ studies for the treatment of patients with moderate or severe lupus.

The presentations, followed by key conclusions, are listed below:

1)      Inhibition of B-cell Receptor (BCR) Signaling with Epratuzumab and the Effects of Alpha-2,6-sialic Acid Removal.

  • Key conclusion - Intracellular BCR signals can be partially inhibited by the binding of epratuzumab to the CD22 receptor. The interactions of CD22 with sialic acid have a modulatory, but not an essential role in mediating epratuzumab's effects on BCR inhibition. These data are consistent with the potential of targeting CD22 to raise the threshold of BCR activation, which also provides additional control of B-cell function.  The study offers further understanding of the mechanism of action of targeting CD22 in human autoimmune diseases. 

2)      Epratuzumab-related SLE Patients Report Improvements in Health-related Quality of Life (HRQoL): Interim Results from an Open-label Extension Study.

  • Key conclusion - Patients treated with epratuzumab in the open-label extension study following the randomized double-blind ALLEVIATE trials reported clinically meaningful improvements in HRQoL, sustained over 2 years of treatment. The greatest improvements were observed in the Role Physical, Bodily Pain, General Health and Vitality domains. Mental Health scores approached normal values by week 12 and were maintained thereafter. 

3)      Characterization of SLE Patients Experiencing Flares in Epratuzumab Clinical Trials.

  • Key conclusion - In this post-hoc exploratory analysis, the proportion of patients who flared in the ALLEVIATE trials was highest in the placebo group (37.8% vs 30.0% in the epratuzumab 360-mg group and 9.1% in the epratuzumab 720-mg group). In EMBLEM, the later dose-finding trial, the proportion of patients experiencing a flare was low in all groups with small differences between groups: 5.3% for placebo, 7.7% for 100-mg epratuzumab every other week (EOW), 5.3% for 400-mg EOW, 5.7% for 600-mg weekly, 8.1% for 1200-mg EOW and 5.3% for 1800-mg EOW. The lower incidence in EMBLEM may be attributable to the shorter duration of the trial and the fact that there was less time for steroid reduction than in the ALLEVIATE trial.

Cynthia Sullivan, President and CEO of Immunomedics, commented: "Results of our ALLEVIATE trials are beginning to be reported by UCB and Immunomedics, and will show the safety and initial evidence of activity of epratuzumab in lupus patients, including durability of responses. We hope to publish our findings from these earlier studies in appropriate rheumatology journals as the ongoing EMBODY registration trials continue to enroll patients."

About Immunomedics

Immunomedics 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. 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, cytokines 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 also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us 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, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 199 patents issued in the United States and more than 400 foreign patents, protects our product candidates and technologies. For additional information on us, please visit our website at 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, potential collaborations, 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 any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company's control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer 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.

For More Information:
Dr. Chau Cheng
Director, Investor Relations & Grant Management
(973) 605-8200, extension 123