Scientific Data on Epratuzumab in Systemic Lupus

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News Desk 2018
Scientific Data on Epratuzumab in Systemic Lupus Erythematosus to be Presented at EULAR 2014

MORRIS PLAINS, N.J., June 9, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq: IMMU ) today announced that scientific data on epratuzumab, an investigational therapy for the treatment of systemic lupus erythematosus (SLE), also known as lupus, will be presented at the European League Against Rheumatism (EULAR) 2014 Annual Congress to be held in Paris, France, from June 11 – 14, 2014.

Epratuzumab is an investigational medicine in Phase III clinical development for the treatment of SLE. Epratuzumab is a monoclonal antibody that targets CD22 - a B-cell-specific protein that regulates B-cell activity. 1,2 Epratuzumab is not approved for the treatment of SLE by any regulatory authority worldwide.

Immunomedics has granted UCB exclusive worldwide rights to develop, market, and sell epratuzumab for all autoimmune disease indications.

Following is a guide to the presentations being given as posters or abstracts at EULAR 2014:

Investigational studies of epratuzumab in systemic lupus erythematosus

1. [THU0023]: Correlation of Laboratory and Clinical Parameters with British Isles Lupus Assessment Group Response in an Open-Label Extension Study of Epratuzumab in Systemic Lupus Erythematosus
Furie, R. A. et al.

  • Date/Time: Thursday June 12th; 11:45 – 13:30
  • Session Info: Poster session, Poster Area, Level 1
  • Date/Time: Friday June 13th; 12:00 – 13:15
  • Session Info: Poster Tour, Level 2

2. [FRI0383]: Safety, Pharmacokinetics, and Pharmacodynamics of Epratuzumab in Japanese Patients with Moderate-to-Severe Systemic Lupus Erythematosus: Results from a Phase 1/2 Study
Yamamoto, J. et al.

  • Date/Time: Friday June 13th; 11:45 – 13:30
  • Session Info: Poster Session, Poster Area D, Level 4

3. [AB0023]: In Vivo Effects of Epratuzumab, a Monoclonal Antibody Targeting Human CD22, on B Cell Function in Human CD22 Knock-in (Huki) Mice
Brandl, C. et al.

  • Abstract book

Systemic lupus erythematosus

4. [SAT0101]: A 'Real-World' Characterization of 'Moderate-to-severe' Systemic Lupus Erythematosus
Strand, V. et al.

  • Date/Time: Saturday June 14th; 10:15 – 12:00
  • Session Info: Poster Session, Poster Area A, Level 1

5. [AB1117]: Burden of Disease in Systemic Lupus Erythematosus Patients Treated with Corticosteroids 
Strand, V. et al.

  • Abstract book

6. [AB1116]: Treatment of Patients with 'Moderate-to-severe' Systemic Lupus Erythematosus 
Strand, V. et al.

  • Abstract book

References

  1. Sanz I. & Lee F. Eun-Hyung. B cells as therapeutic targets in SLE. Nat. Rev. Rheumatology; 6. 2010; 326-337.
  2. Walker J. & Smith K. CD22: an inhibitory enigma. Immunology; 123. 2008; 314-325.

About Immunomedics

Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics' advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of nine clinical-stage product candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB), who has worldwide rights in non-cancer indications to Immunomedics' Phase III product candidate, epratuzumab. UCB expects Phase III data in systemic lupus erythematosus (SLE) in the first quarter of 2015. Immunomedics is exploring epratuzumab in oncology in collaboration with outside cancer study groups. Immunomedics' most advanced wholly owned candidate is 90 Y-clivatuzumab tetraxetan, which is in an ongoing Phase III registration trial in patients with pancreatic cancer. Immunomedics' portfolio of wholly owned product candidates also includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxicity effects that typically occur when these chemotherapeutic agents are dosed alone. Immunomedics' most advanced ADCs are IMMU-132 and IMMU-130, which are in Phase I/II trials for a number of solid tumors and metastatic colorectal cancer (mCRC), respectively. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and pre-clinical development. These include bispecific antibodies which have application as T-cell redirecting immunotherapies targeting cancers and infectious diseases as well as next-generation therapies in cancer and autoimmune disease. Immunomedics creates these bispecific antibodies using its patented DOCK-AND-LOCK™ (DNL™) protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 248 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. Immunomedics' strength in intellectual property has resulted in the top-4 ranking in the January 2014 Patent Board scorecard in the Biotechnology industry. For additional information on the Company, please visit its website at www.immunomedics.com . The information on its 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 (including the funding therefor, outcomes, timing or associated costs), 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, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on UCB for the further development of epratuzumab for non-cancer indications, risks associated with the outcome of pending litigation, 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.

Dr. Chau Cheng Senior Director, Investor Relations & Grant Management (973) 605-8200, extension 123

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