MORRIS PLAINS, N.J., Dec. 4, 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 stockholders of the Company, at its 30 th annual meeting, elected all six nominees to serve as directors of the Company until the next annual meeting; approved the executive compensation by advisory vote; and ratified the selection of KPMG LLP as the Company's independent registered public accounting firm for the current fiscal year. Thereafter, the Board reappointed Dr. David M. Goldenberg as Chairman and Mr. Brian Markison as Lead Independent Director.
In her overview of significant developments for the Company, Cynthia L. Sullivan, President and Chief Executive Officer, remarked, "This past year has been very exciting and productive for a number of reasons. First and foremost is the completion of the Phase Ib trial of yttrium-90-labeled clivatuzumab tetraxetan in patients with advanced pancreatic cancer who had received at least two prior therapies. The study has provided the crucial information on patient enrollment and survival to support our plans to go forward with the pivotal Phase III PANCRIT-1 trial in the same patient population, which is on track to begin by the end of this year or the beginning of 2014. Interestingly, although the Phase Ib trial completed enrollment about 10 months ago, we are still following a small group of patients who have not progressed, and in fact a second patient in the combined treatment arm has just presented evidence of having a partial response, or a 30% reduction of the sum of the diameters of target tumors without the development of new disease. We are gratified that these advanced pancreatic cancer patients who received at least 2 prior treatments tolerated our therapy well, with some having evidence of benefit and improved survival.
"Another new and exciting development is with our antibody-drug conjugates (ADCs) for solid cancer therapy. Both IMMU-132 (TROP-2-SN-38) and IMMU-130 (labetuzumab-SN-38) have produced partial responses and stable disease in patients who have failed multiple prior therapies, including irinotecan, the parent drug of SN-38. While IMMU-130 is focused on colorectal cancer, IMMU-132 has produced partial responses in very advanced colorectal, triple negative breast and small cell lung cancer patients. Both programs have entered into Phase II clinical development," Ms. Sullivan added.
"In all, more than 80%, or 20 of the 24 assessable patients, showed evidence of disease control with stable disease or partial responses achieved with IMMU-132 in the Phase I trial just completed. Impressively, this includes 8 patients who had failed prior irinotecan-containing therapies. Because irinotecan is the parent of SN-38, we postulate that the increased amount of SN-38 delivered to the tumors by our ADCs overcomes the tumor's resistance to this class of drugs," commented Dr. William A. Wegener, Senior Vice President of Clinical Research, in his summary of the year's clinical developments focusing on the Company's two most exciting programs, one in pancreatic cancer and the other in solid cancers with our antibody-SN-38 conjugates.
"In terms of time-to-progression for the IMMU-132 program, of the 20 patients who reported a partial response or stable disease as their best response, the duration ranges were from 4.5 weeks to more than 35 weeks, with 7 patients continuing with their treatments. The ability to achieve some measure of disease control with this ADC by itself is impressive, since this is a group of heavily pretreated patients with few other therapeutic options. To date, there have been no anti-antibody or anti-SN38 immune responses in patients treated with IMMU-132, even with long-term therapy. Major side effects are neutropenia and diarrhea, with minor side effects being fatigue and alopecia," concluded Dr. Wegener.
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 238 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 www.immunomedics.com . 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.
Dr. Chau Cheng Senior Director, Investor Relations & Grant Management (973) 605-8200, extension 123
