Immunomedics Awarded Additional Intellectual Property Protection for IMMU-140, an Antibody-Drug Conjugate With Dual-Therapeutic Potential

Immunomedics, Inc. (Nasdaq:IMMU) today announced the issuance of U.S. Patent 9,522,959 for additional claims under the patent family, “Dosages of immunoconjugates of antibodies and SN-38 for improved efficacy and decreased toxicity.”
The issued patent provides additional coverage for IMMU-140, the third antibody-drug conjugate (ADC) based on the Company’s award-winning SN-38 platform technology. The lead investigational product from that program is sacituzumab govitecan (IMMU-132), which has continued to produce encouraging results in a Phase 2 study in patients with metastatic triple-negative breast cancer (TNBC), and has been designated a Breakthrough Therapy by the FDA for TNBC patients who have received at least two prior therapies for their late-stage disease.Dr. David M. Goldenberg, Chairman, Chief Scientific Officer and Chief Patent Officer, stated, “IMMU-140 is our newest investigational product built on the same ADC platform used in IMMU-132, and creates the promise of a potential new treatment alternative for cancer patients and new value for our shareholders. We believe IMMU-140 provides an added benefit as a dual-therapeutic and are pleased to receive this new patent. The dual-therapeutic potential of IMMU-140 warrants its clinical development in a range of HLA-DR-positive hematopoietic and solid cancers.”Dr. Goldenberg added, “The progress that has been made with IMMU-140 underscores Immunomedics’ commitment to executing on its strategy. The attainment of this milestone is the result of years of dedication and hard work by our talented team, and we are committed to continuing this positive momentum. As always, we remained focus on achieving our additional upcoming milestones, which we expect will create additional benefits for patients and Immunomedics’ stockholders.”The allowed claims in the new patent, which will expire in July 2033, protect the use of IMMU-140 in HLA-DR-expressing B-cell lymphoma, B-cell leukemia, skin, esophageal, stomach, colon, rectal, pancreatic, lung, breast, ovarian, bladder, endometrial, cervical, testicular, melanoma, kidney, or liver cancer. IMMU-140 is comprised of the humanized anti-HLA-DR antibody, IMMU-114, conjugated to SN-38, through the Company’s proprietary linker, CL2A. Thus, this ADC has dual activity, combining the signaling functions of the parental antibody, IMMU-114, with the cytotoxicity of SN-38. Further, the IMMU-140 product candidate builds on the safety and efficacy of its parental antibody, IMMU-114, being studied clinically in patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), where results to-date with a subcutaneous therapy of IMMU-114 are showing promising activity in refractory/relapsed patients, and with a relatively safe profile.In a preclinical study presented at the 2016 Annual Meeting of the American Society of Hematology, IMMU-140 was shown to have higher potency than naked IMMU-114 in acute lymphocytic leukemia (ALL) and acute myelocytic leukemia (AML), and an added, if not significant, survival benefit in experimental multiple myeloma (MM) and CLL. Importantly, it did not produce any undue toxicity in these four animal models of human blood cancers.As previously announced, Immunomedics is focused on achieving a number of critical milestones in the near-term including:Preparing to submit a Biological License Application (BLA) to the FDA for accelerated approval for IMMU-132 for patients with metastatic TNBC in mid-2017;Nearing completion of enrolling 100 TNBC patients into the ongoing Phase 2 clinical trial of IMMU-132 by year-end 2016;Presenting interim results of Phase 2 clinical trials of IMMU-132 for patients with urinary bladder cancer at the ASCO symposium on genitourinary cancers to be held in early 2017;Continuing preclinical development of the new ADC, IMMU-140, as a therapeutic for five different blood cancers (NHL, CLL, ALL, AML, MM); poster presented at 2016 meeting of American Society of Hematology (ASH);Pursuing licensing and other strategic activities with regard to IMMU-132 and other clinical and preclinical pipeline drug development candidates, as well as platform technologies, with the support of Greenhill & Co. as its financial advisor;Initiation of Phase 3 Confirmatory Trial in TNBC during early 2017;Potential for Breakthrough Therapy Designation in small-cell and non-small-cell lung, and urinary bladder cancers; andOnce IMMU-132 is partnered, the Company could then advance many other preclinical assets into clinical development and even other licensing arrangements; licensing discussions involving some of these other assets are in fact ongoing.
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 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 304 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.For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com
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Dan Katcher / Ed Trissel / Nick Lamplough
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Dan Burch/Bob Marese
MacKenzie Partners, Inc.
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