Immunomedics Awarded U.S. Patent for Novel Immuno-Oncology

MORRIS PLAINS, N.J., April 20, 2016 (GLOBE NEWSWIRE) -- Immunomedics, Inc. , (Nasdaq: IMMU ) today announced the issuance of U.S. Patent No. 9,315,567 to its majority-owned subsidiary, IBC Pharmaceuticals, Inc., for a new patent family “T-Cell Redirecting Bispecific Antibodies for Treatment of Disease,” which will expire in August 2033.

The new invention concerns methods of use of T-cell redirecting bispecific antibodies, created with the Company’s proprietary DOCK-AND-LOCK ^® (DNL ^® ) protein conjugation platform technology. The issued claims cover use of DNL ^® complexes that simultaneously bind to the CD3 T-cell antigen and the Trop-2 tumor antigen, which is expressed by many solid cancers. The claims specifically cover use of the Company’s proprietary (E1)-3s bispecific antibody .

The use of bispecific antibodies to redirect T cells for the killing of targeted tumor cells has shown considerable promise both preclinically and clinically. The Company has previously reported preclinical results that showed (E1)-3s effectively induced T-cell redirected killing of pancreatic and gastric cancer cell lines. ¹ Furthermore, interferon-alpha significantly improved (E1)-3s-mediated T-cell killing of human gastric and pancreatic cancer cells both in vitro and in vivo . ²

More importantly, (E1)-3s was highly active without inducing high-level production of secondary cytokines, thereby reducing the risk of cytokine release syndrome, also known as cytokine storm, which is often associated with immunotherapy using T-cell-directed antibodies.

“Redirection of T-cell effector functions is an exciting new approach in immuno-oncology research,” remarked Cynthia L. Sullivan, President and Chief Executive Officer. “We believe our novel therapeutic may be even more effective when combined with our antibody-drug conjugates currently in clinical studies.”

References

1. Rossi DL, Rossi EA, Cardillo TM, Goldenberg DM and Chang CH. A new class of bispecific antibodies to redirect T cells for cancer immunotherapy. Mabs , vol. 6, p. 381-391, 2013.
2. Rossi EA, Rossi DL, Cardillo TM, Chang CH and Goldenberg DM. Redirected T-cell killing of solid cancers targeted with an anti-CD3/Trop-2-bispecific antibody is enhanced in combination with interferon-α. Molecular Cancer Therapeutics , vol. 13(10), p. 1-11, 2014.

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 FDA for the treatment of patients with triple-negative breast cancer who have failed at least 2 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 287 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, outcomes, timing or associated costs), 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, new product development (including clinical trials outcome and regulatory requirements/actions), the Company’s dependence on business collaborations in order to further develop our products and finance our operations, 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 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.

For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Corporate Secretary (973) 605-8200, extension 123 ccheng@immunomedics.com