Healthcare Industry News:  breast cancer 

Biopharmaceuticals Oncology

 News Release - December 9, 2011

Immunomedics Creates Targeted Therapeutics for Solid Cancers

Novel Agents Constructed Using the Company's Patented Dock-and-Lock Method

SAN ANTONIO, Dec. 9, 2011 -- (Healthcare Sales & Marketing Network) -- 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 presented two preclinical studies aimed at producing potent therapeutics for diverse epithelial carcinomas, including breast cancers. Results from these studies were reported at the 2011 CTRC-AACR San Antonio breast cancer Symposium, which is organized by the Cancer Therapy & Research Center at UT Health Science Center San Antonio, the American Association for Cancer Research, and Baylor College of Medicine.

The first agent is based on an amphibian enzyme called ranpirnase (Rap), which exhibits anti-tumor activity in diverse cancers. The potency of Rap can be enhanced by attaching it to a tumor-targeting antibody. In this study, a new class of antibody-Rap conjugates was generated using Dock-and-Lock (DNL), the Company's proprietary protein engineering platform. Designated as E1-Rap and 22-Rap, the two DNL constructs each contains four copies of Rap linked to the humanized anti-TROP2 antibody, hRS7, and epratuzumab, the humanized anti-CD22 antibody, respectively.

The Rap-based therapeutics were evaluated in a panel of breast cancer cell lines. Four of the 7 cell lines examined expressed high levels of TROP2. As a result, E1-Rap was at least 10-fold more potent than 22-Rap in these cell lines, with cell-killing values in the nanomolar or sub-nanomolar range. These results suggest that E1-Rap should be further examined as a new cancer therapeutic for TROP2-expressing breast and other solid tumors.

In addition to TROP2, the expression of type-I insulin-like growth factor receptor (IGF-1R) is also elevated in breast and other epithelial cancers. The goal of the second study presented at the same conference was to explore the potential of 1R-(E1)-(E1), a bispecific hexavalent antibody constructed from linking a humanized anti-IGF-1R antibody to two fragments of hRS7 anti-TROP2 antibody using DNL.

1R-(E1)-(E1) was evaluated in three breast cancer cell lines that express both IGF-1R and TROP2. For the cell line with the most invasive ability, 1R-(E1)-(E1), at a low concentration of 75 ug/mL, was able to reduce the invasion to less than 25% compared to untreated control. Furthermore, the ability of the DNL-derived bispecific antibody to inhibit anchorage-independent growth was demonstrated at 200 nM, with a statistically significant difference when compared with samples treated with parental antibodies at the same concentrations.

These in vitro results warrant further evaluation of 1R-(E1)-(E1) in other breast cancer cell lines as well as exploring new bispecific hexavalent antibody constructs that comprise different antibodies capable of targeting additional solid cancers.

In remarks by Company President and Chief Executive Officer, Cynthia L. Sullivan: "We are pleased to introduce this new technology and novel product candidates at this breast cancer meeting. Both DNL constructs represent novel agents targeting important receptors on a variety of solid cancers, including breast cancers, and have shown encouraging therapeutic results in these early preclinical models."

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. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 185 patents issued in the United States and more than 400 foreign patents, protects our product candidates and technologies. 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 new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab 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.


Source: Immunomedics

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