MORRIS PLAINS, N.J., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU) today announced the issuance of U.S. Patent 9,492,566, the 32nd U.S. patent protecting the use of sacituzumab govitecan (IMMU-132), the Company’s lead antibody-drug conjugate (ADC), for the treatment of patients with Trop-2-positive cancers.
In an ongoing Phase 2 clinical study, sacituzumab govitecan has produced encouraging objective response rates and durable responses in heavily-pretreated patients with metastatic triple-negative breast (TNBC), small-cell and non-small-cell lung, and urothelial cancers.
The promising results in solid cancers have motivated the Company to expand its ADC program to include liquid tumors. Using the same CL2A linker and the SN-38 toxic payload, the Company created IMMU-140, the subject of U.S. Patent 9,493,573 issued for additional claims under the patent family, “Dosages of immunoconjugates of antibodies and SN-38 for improved efficacy and decreased toxicity.”
The parent antibody in IMMU-140 is an anti-HLA-DR IgG4 antibody (IMMU-114) that has demonstrated evidence of treatment responses in more than 50% of assessable patients in a Phase 1 study in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) without reaching a maximum tolerated dose. At the Annual Meeting of the American Society of Hematology, to be held December 3-6, 2016, the Company will present preclinical results on in vitro and in vivo activity of IMMU-140 in animal models of five liquid cancers, NHL, CLL, acute myelocytic and lymphocytic leukemia, and multiple myeloma.
The Company has also created yet another ADC targeting B-cell hematologic malignancies. Protected by the new U.S. Patent 9,493,574 under the same patent family of “Dosages of immunoconjugates of antibodies and SN-38 for improved efficacy and decreased toxicity,” this new ADC comprises a humanized anti-CD19 antibody, hA19, conjugated to SN-38.
All three new ADC patents will expire in July 2033.
“We are pleased to receive these new patents, which provide extensive intellectual property protection for our robust ADC program that has the potential to address approximately 90% of all human cancers based on the number of estimated new cases in the U.S., as compiled by the American Cancer Society,” commented Cynthia L. Sullivan, President and Chief Executive Officer.
Also issued today was U.S. Patent 9,492,561 to IBC Pharmaceuticals, Inc., the Company’s majority-owned subsidiary, for the new patent family “Dock-and-Lock (DNL) complexes for delivery of interference RNA.” This new patent concerns compositions for targeted delivery of small interfering RNA (siRNA) to treat a variety of disease states, including cancer, autoimmune disease, immune dysfunction, inflammatory disease, or infectious disease, and expires on March 24, 2026.
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 299 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, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), 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 the Company’s ability to repay its outstanding indebtedness, if and when required, 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.
Last updated on: 15/11/2016
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