MORRIS PLAINS, N.J., March 08, 2016 (GLOBE NEWSWIRE) — Immunomedics, Inc., (Nasdaq:IMMU) today announced that the issuance of U.S. patent no. 9,278,129 for the Company’s new patent family “Methods of Treating Rapidly Progressive Glomerulonephritis Using Chimeric and Humanized Anti-Histone Antibodies,” which will expire in February 2034.
This new patent concerns methods of use of the Company’s proprietary anti-histone antibody. This antibody has potential use in a variety of autoimmune, septic and inflammatory diseases. The issued claims cover use in rapidly progressing glomerulonephritis, a kidney autoimmune disease that is rapidly fatal if left untreated.
Histones are important proteins that function as structure components of chromatin. Besides having nuclear functions, histones can also be released into circulation by both damaged and activated cells. Recent studies have indicated that circulating histones play a crucial role in sepsis and acute respiratory distress syndrome, thus suggesting that histones could serve as promising therapeutic targets for infectious and inflammatory disorders.
Earlier this month, two additional U.S. patents were issued to the Company. Patent no. 9,272,029 relates to the Company’s new patent family “Interferon-Lambda Antibody Complexes,” which was assigned to IBC Pharmaceuticals, Inc., the Company’s majority-owned subsidiary, and has an expiration date of April 8, 2030.
This patent concerns methods and compositions for creating antibody complexes of interferon-lambdas (IFN-λs) using the Company’s proprietary DOCK-AND-LOCK™ protein conjugation platform technology. IFN-λs are a group of cytokines that, in animal models, induce both tumor cell death and destruction through innate and adaptive immune responses, suggesting that local delivery of the cytokine might be an adjunctive strategy in the treatment of human malignancies.
The other patent, 9,272,057, relates to additional claims under the patent family “Combining Radioimmunotherapy and Antibody-drug Conjugates (ADCs) for Improved Cancer Therapy.” This new patent concerns compositions and methods of treating pancreatic cancer using radiolabeled antibodies combined with ADCs. The allowed claims cover sacituzumab govitecan (IMMU-132), the Company’s lead ADC that has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with triple-negative breast cancer who have failed at least 2 prior therapies for metastatic disease, and clivatuzumab tetraxetan, which is being evaluated in a Phase 3 (PANCRIT-1) registration trial as a radiolabeled antibody in patients with advanced pancreatic cancer.
“These new patents are the results of our continuing innovative efforts to develop new agents and treatment regimens to improve the management of patients with cancer, autoimmune diseases and other serious diseases,” commented Cynthia L. Sullivan, President and Chief Executive Officer. “We believe that they enhance our commercial assets and rich pipeline,” Ms. Sullivan added.
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’ most advanced candidate is 90Y-clivatuzumab tetraxetan. This radiolabeled antibody is in an international Phase 3 registration trial in patients with advanced pancreatic cancer. Immunomedics expects patient enrollment to be completed in calendar year 2016. Immunomedics’ portfolio of investigational products also includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. IMMU-132 has received Breakthrough Therapy Designation from FDA for the treatment of patients with triple-negative breast cancer who have failed at least 2 prior therapies for metastatic disease. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. 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 preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 285 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. 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), the Company’s dependence on business collaborations in order to further develop our products and finance our operations, the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and 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.
CONTACT: For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Corporate Secretary (973) 605-8200, extension 123 ccheng@immunomedics.com
