Immunomedics to Provide Clinical Update on Sacituzumab Govitecan (IMMU-132) in Triple-Negative Breast Cancer at San Antonio Breast Cancer Symposium

MORRIS PLAINS, N.J., Nov. 14, 2016 -- Immunomedics, Inc., (Nasdaq:IMMU) today announced that three abstracts have been accepted for presentation at the 2016 San Antonio Breast Cancer Symposium (SABCS) to be held at the Henry B. Gonzalez Convention Center in San Antonio, TX, from December 6-10, 2016. Leading the presentations will be updates on the Phase 2 results of sacituzumab govitecan (IMMU-132), the Company’s lead antibody-drug conjugate (ADC), in patients with metastatic triple-negative breast cancer (TNBC).

Based on earlier results from this single-arm study, the FDA has designated sacituzumab govitecan a Breakthrough Therapy for patients with TNBC who have received two or more prior treatments for their metastatic disease. The updated results to be presented at SABCS will form part of a biologics license application (BLA) the Company plans to submit to the FDA in mid-2017 for accelerated approval in metastatic TNBC.

In addition, the Company will present, for the first time, a preclinical study on an agent from its immuno-oncology program, a Trop-2/CD3 bispecific antibody, for redirected T-cell therapy of TNBC, which can be enhanced by combining with the Company’s proprietary immune checkpoint inhibitor, an anti-PD-1 antibody. The third presentation will describe the Company’s efforts in constructing a novel Trop-2-specific chimeric antigen receptor (CAR) for redirected natural killer-cell therapy of breast, lung, bladder, ovarian, and other cancers.

Details of the three presentations are listed below (all times are in Central Time) and their abstracts are available online at http://www.abstracts2view.com/sabcs/sessionindex.php:

Thursday, December 8, 2016

• Directing NK cells to Trop-2-expressing breast and other cancers, with chimeric antigen receptors (Chang, et al.)
  Poster Session: Tumor Cell and Molecular Biology: Immunology and Preclinical Immunotherapy
  Program Number: P2-04-17
  Abstract # 246
  7:30 a.m. - 9:00 a.m.
  Hall 1

Friday, December 9, 2016

• Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate (ADC) for the treatment of relapsed/refractory, metastatic triple-negative breast cancer (mTNBC): Updated results (Bardia, et al.)
  Poster Session: Treatment: Advanced Therapy - Targeted
  Program Number: P4-22-15
  Abstract # 339,
  7:30 a.m. - 9:00 a.m.
  Hall 1

Saturday, December 10, 2016

• Enhanced efficacy of redirected T-cell therapy of TNBC with a Trop-2/CD3 bispecific antibody in combination with a checkpoint inhibitor (Rossi, et al.)
  Poster Session: Treatment: Antibody-Based Regimens
  Program Number: P6-14-01
  Abstract # 510,
  7:30 a.m. - 9:00 a.m.
  Hall 1

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 299 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
[email protected]