Epratuzumab Data From Phase IIB EMBLEM(TM) Study Presented at 9th International Congress on Systemic Lupus Erythematosis

        Print
| Source: Immunomedics, Inc.

MORRIS PLAINS, N.J., June 25, 2010 (GLOBE NEWSWIRE) -- UCB (Euronext:UCB) and Immunomedics Inc. (Nasdaq:IMMU) today announced that data for new lupus drug candidate, epratuzumab, were presented at the 9th International Congress on Systemic Lupus Erythematosis in Vancouver, Canada. These data showed that, in patients with moderate to severe systemic lupus erythematosus (SLE), epratuzumab provided clinically meaningful1 and statistically significant*1 improvements in disease activity.  In the second half of 2010, UCB will initiate two Phase III studies of epratuzumab for the treatment of patients with moderate to severe lupus.

The presented data, followed by key conclusions, are listed below:

  • "Epratuzumab Demonstrates Clinically Meaningful Improvements in Patients with Moderate to Severe Systemic Lupus Erythematosus (SLE): Results from EMBLEM™, a Phase IIb Study" [Oral presentation on Friday June 25th. Session: CS6.3 - NEW DRUGS IN DEVELOPMENT (13:30-15:30)]:
  • Key conclusion - Epratuzumab (cumulative dose 2400mg) demonstrated clinically meaningful and statistically significant* improvements in disease activity in patients with moderately to severely active SLE at 12 weeks, with responder rates twice those of placebo.  Results validate the combined index emphasizing BILAG and support phase III trials of epratuzumab in SLE. 1
  • "BILAG-Measured Improvement in Moderately and Severely Affected Body Systems in Patients with Systemic Lupus Erythematosus (SLE) by Epratuzumab: Results from EMBLEM™, a Phase IIb Study" [Oral presentation on Friday June 25th. Session: CS6.4 - NEW DRUGS IN DEVELOPMENT (13:30-15:30)]:
  • Key conclusion - Treatment with epratuzumab 600mg weekly x 4 (for a cumulative dose of 2400 mg) during a 12-week cycle provided greater BILAG improvement over placebo in disease activity in all affected body systems.  Efficacy was particularly prominent in cardiorespiratory and neuropsychiatric systems in which symptom improvements are often difficult to achieve.  Within specific body systems, the majority had symptom reduction or absence of active disease after treatment. This analysis supports that epratuzumab may be an effective treatment for SLE. 2

EMBLEM™ was a 12-week, multicenter, phase IIb, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of epratuzumab, and to define a dose and regimen in patients with moderate to severe SLE.  The primary efficacy measure in EMBLEM™ was a combined response index endpoint including several indices of SLE disease activity, primarily emphasizing BILAG**.

Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.

Epratuzumab is a humanized monoclonal antibody targeting CD22 and modulating B-cell activity.  Although the exact role of CD22 is not fully understood, it is considered to be a regulator of B-cell function.  B cells are known to contribute to SLE by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself, resulting in inflammation and tissue damage.

Data accepted for presentation at this congress also include:

  • "The effects of the anti-CD22 monoclonal antibody epratuzumab on peripheral blood B cells and immune responses in vivo and immunoglobulin production in vitro" [Oral presentation on Friday, June 25, 2010. Session: CS5.4 - B CELLS IN LUPUS (10:00-11:30)]:
  • Key conclusion - Epratuzumab treatment caused a reduction in B cells but had no effect on the capacity to raise an antibody response to challenge antigens in animal models. The production of immunoglobulin by B cells in culture was also unaffected by epratuzumab.  Although not yet tested clinically, this might indicate that the efficacy of epratuzumab in SLE patients is unlikely to be accompanied by a gross effect on the capacity to generate an adaptive immune response.3
  • "The effects of the anti-CD22 monoclonal antibody Epratuzumab on B-cell surface proteins" [Poster presentation on Friday, June 25th. Session: PO1.I - IMMUNOLOGY - B CELLS (11:30-13:30)]:
  • Key conclusion - Epratuzumab stimulated rapid internalization of its target, CD22, on human peripheral blood B cells in vitro but had no consistent effect on a range of other B-cell markers. This could lead to modulation of B-cell functional responses that are regulated specifically by CD22, which may be relevant in the context of SLE.4
  • "Impact of lupus on patients' employment, family relationships, and overall wellbeing" [Poster presentation on Friday, June 25th, 2010. Session: PO1.F – EPIDEMIOLOGY [(11:30-13:30)]:
  • Key conclusion - These results indicate that people affected by lupus experience frequent symptoms which they identify as flares, with a significant impact on employment, physical well-being and everyday living.  Fatigue, joint and muscle pain, and skin disorders are the most common physical symptoms reported, and may have a high impact on quality of life regardless of current standards of care.  Most patients with lupus are not satisfied with the effects of the treatments they are taking, and place a high priority on communications with family, friends and healthcare professionals.5

* p values were not adjusted for multiple comparisons

**BILAG (British Isles Lupus Assessment Group) is a comprehensive scoring system for assessing both current SLE disease activity and changes in that activity since the patient was last seen.

About Epratuzumab

Epratuzumab is a humanized anti-CD22 monoclonal antibody not yet licensed and under investigation for the treatment of SLE.  CD22 is a B-cell specific surface protein that is considered to be involved in B-cell function. The product was licensed to UCB from Immunomedics.  Under the license agreement, UCB owns the rights and is responsible for the clinical development, and commercialization of epratuzumab in all autoimmune disorders including SLE.

About EMBLEM™

In EMBLEM™ patients were randomized to 1 of 6 intravenous regimens: placebo (PBO), epratuzumab cumulative dose (cd) 200, 800, 2400, or 3600 mg in equal divided doses using 2 every other week (EOW) infusions or epratuzumab cd 2400 mg delivered as 4 equal infusions 1 week apart. Concomitant oral corticosteroids (CS) and immunosuppressives (IS) were stable for at least 5 and 28 days, respectively, prior to first study drug infusion. Primary endpoint was responder rate on a combined index of clinical disease activity at week 12 (defined as reduction of all baseline (BL) BILAG 2004 A to B/C/D and BL BILAG B to C/D, no BILAG worsening in other organ systems, and no deterioration in SLEDAI or physician global assessment [VAS]), with no CS, IS and antimalarials increase over BL dose. The study was not powered to detect statistical differences between treatment arms.

About systemic lupus erythematosus (SLE)

SLE, commonly referred to as lupus, is a chronic and potentially fatal autoimmune disease with a variable and unpredictable course. Antibodies are generated against the body's own nuclear proteins causing the immune system to attack its own cells and tissues resulting in inflammation and tissue damage. This can occur in any part of the body, but most often targets the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system. 

Lupus is characterized by periods of flares, or exacerbations, interspersed with periods of improvement or remission. The Lupus Foundation of America estimated that between 1.5-2 million Americans have a form of lupus, 90 percent of whom are women. Symptoms and diagnosis occur most often between the ages of 15 and 45. In the U.S., lupus is more common in African Americans, Latinos, Asians, and Native Americans than in Caucasians.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 9,000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).

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 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 149 patents issued in the United States and more than 375 other patents issued worldwide, 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.

Forward-looking statements - UCB

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

Forward looking statements relating to Immunomedics, Inc.

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 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.

References

1.      Wallace DJ et al. Epratuzumab Demonstrates Clinically Meaningful Improvements in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE): Results from EMBLEM™, a Phase IIb Study. 2010, 9th International Congress on Systemic Lupus Erythematosus. Vancouver, Canada, June 24 – 27.

2.      Gordon C et al. BILAG-Measured Improvement in Moderately and Severely Affected Body Systems in Patients With Systemic Lupus Erythematosus (SLE) by Epratuzumab: Results from EMBLEM™, a Phase IIb Study. 2010, 9th International Congress on Systemic Lupus Erythematosus. Vancouver, Canada, June 24 – 27.

3.      Brown D et al. The effects of the anti-CD22 monoclonal antibody epratuzumab on peripheral blood B cells and immune responses in vivo and immunoglobulin production in vitro. 2010, 9th International Congress on Systemic Lupus Erythematosus. Vancouver, Canada, June 24 – 27.

4.      Brown D et al. The effects of the anti-CD22 monoclonal antibody Epratuzumab on B cell surface proteins. 9th International Congress on Systemic Lupus Erythematosus. Vancouver, Canada, June 24 – 27.

5.      Crimmings M et al. Impact of lupus on patients' employment, family relationships, and overall wellbeing. 2010, 9th International Congress on Systemic Lupus Erythematosus. Vancouver, Canada, June 24 – 27

Immunomedics, Inc.
Dr. Chau Cheng, Associate Director, Investor Relations & 
 Business Analysis
(973) 605-8200, extension 123