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MORRIS PLAINS, N.J., Oct. 19, 2016 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today announced the issuance of U.S. Patent 9,458,242 for additional claims under the patent family “Dosages of immunoconjugates of antibodies and SN-38 for improved efficacy and decreased toxicity.” This new patent, which will expire in July 2033, covers the use of labetuzumab govitecan (IMMU-130), the Company’s second investigational antibody-drug conjugate (ADC) for solid cancer therapy.
Labetuzumab govitecan is composed of SN-38, the active metabolite of irinotecan, an FDA approved chemotherapy for colorectal cancer, linked to labetuzumab, the Company’s humanized antibody that targets the carcinoembryonic antigen (CEACAM5), which is expressed on colorectal and other solid cancers. This ADC, at the 10 mg/kg dose level, has been active in the therapy of patients with metastatic colorectal cancer who had failed multiple prior therapies, including irinotecan.
“We are very encouraged by the results with IMMU-130 from an open-label Phase 2 study, which has completed patient enrollment with patient follow-up continuing,” commented Cynthia L. Sullivan, President and Chief Executive Officer. “We have had an end-of-Phase 2 discussion with the FDA for a future registration pathway for this ADC. One Phase 3 study design under consideration includes evaluating IMMU-130 in patients with metastatic colorectal cancer who have received two or more prior therapies,” Ms. Sullivan added.
Also issued today was U.S. Patent 9,457,072 to IBC Pharmaceuticals, Inc., the Company’s majority-owned subsidiary, for additional claims under the patent family “Dock-and-Lock® (DNL®) vaccines for cancer therapy.” This new patent, which will expire in March 2026, concerns methods and compositions for creating anti-cancer vaccine complexes using the Company’s proprietary DNL® protein conjugation platform technology. These DNL® complexes have the ability to simultaneously bind to dendritic cells on one arm and to tumor markers on cancer cells using the other arm. In so doing, these anti-cancer vaccine DNL® complexes are designed to induce an immune response against their targeted cancer cells, which could inhibit the growth of, or eliminate, the cancer cells.
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 eight clinical-stage product candidates. Immunomedics’ portfolio of investigational products 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 the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two 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 290 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, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, 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.
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