Immunomedics Announces IMMU-132 is Active in Patients Refractory to Irinotecan

NEW YORK, Nov. 8, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that some patients who had failed prior therapy with irinotecan or camptosar, both topoisomerase-1 inhibitors, responded to IMMU-132, the Company's lead antibody-drug conjugate (ADC) in clinical development for the treatment of patients with solid cancers.

Dr. Allyson Ocean of Weill-Cornell Medical College, New York, NY, was invited by the Program Chairs to present the updated results at the Symposium, which is jointly organized by the Mount Sinai School of Medicine and the Chemotherapy Foundation, a non-profit organization supporting cancer research, in collaboration with The Tisch Cancer Institute.

An overall disease control rate of 82% in 22 computed tomography-assessable patients were reported. These include 15 patients with stable disease as their best response and 3 patients, one in each of triple-negative breast, colorectal and small-cell lung cancers, with a partial response.

For the 18 patients who responded to IMMU-132, 8 had failed prior therapies with irinotecan or camptosar. Because irinotecan is the parent of SN-38, the Company's drug of choice in IMMU-132, we postulate that the increased amount of SN-38 delivered to the tumors by IMMU-132 overcomes the tumor's resistance to this class of drugs.

"We are enthused that IMMU-132 has shown activity in a patient population with advanced, difficult-to-treat solid cancers that are refractory to multiple prior therapies including irinotecan," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "The trial has been expanded to a Phase II and is enrolling patients rapidly. We look forward to reporting results from this proof-of-concept trial," Ms. Sullivan added.

In addition to the 25 patients enrolled into the Phase I, dose-escalation part of the study, 18 patients have now been enrolled into the expanded Phase II trial. These Phase II patients include 8 with pancreatic cancer, 7 with colorectal cancer, and one patient each with ovarian, triple-negative breast, and gastric cancers.

This study was supported in part by Award Number R43CA171388 from the National Cancer Institute. The content is solely the responsibility of the Company and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. Our lead product candidate, epratuzumab, is currently in two Phase III clinical trials in lupus. In oncology, we are planning to launch a Phase III pivotal trial for clivatuzumab labeled with a radioisotope in advanced pancreatic cancer patients. Other solid tumor therapeutics in Phase II clinical development include 2 antibody-drug conjugates, labetuzumab-SN-38 (IMMU-130) and hRS7-SN-38 (IMMU-132). We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making fusion proteins and multifunctional antibodies. DNL™ is being used particularly to make bispecific antibodies targeting cancers and infectious diseases as a T-cell redirecting immunotherapy, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies. We believe that our portfolio of intellectual property, which includes approximately 235 active patents in the United States and more than 400 foreign patents, protects our product candidates and technologies. Our strength in intellectual property has resulted in the top-10 ranking in the 2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and Pharmaceuticals category. For additional information on us, please visit our website at The information on our 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, 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, risks associated with any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company's control, 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, 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: Dr. Chau Cheng Senior Director, Investor Relations & Grant Management (973) 605-8200, extension 123 ccheng@immunomedics.comSource:Immunomedics, Inc.