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MORRIS PLAINS, N.J., Nov. 13, 2017 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today announced that two of its abstracts were posted online at www.abstracts2view.com/sabcs/ by the San Antonio Breast Cancer Symposium (SABCS). These abstracts provide clinical updates on sacituzumab govitecan (IMMU-132), its lead antibody-drug conjugate (ADC), in patients with metastatic triple-negative breast cancer (mTNBC), and will be presented at the 2017 SABCS to be held at the Henry B. Gonzalez Convention Center in San Antonio, TX, from December 5-9, 2017.
The first abstract, which has been selected for oral presentation, is on 110 mTNBC patients from a single-arm Phase 2 study of IMMU-132. By local radiologist assessment, the objective response rate was 34%, including three complete responses and 34 partial responses. Results of the independent central blinded review along with sensitivity analyses of prior treatment regimens and exploratory biomarker analysis of Trop-2 expression will be presented at the meeting.
The final data set from this Phase 2 study will be included in a Biologics License Application package to be submitted as planned in the first quarter of 2018 to the FDA for accelerated approval as third-line treatment for mTNBC. IMMU-132 has previously been granted Breakthrough Therapy Designation by the FDA based on earlier results from a smaller cohort in the Phase 2 study.
The second abstract, a poster presentation, is on the design of the Phase 3 ASCENT trial to confirm the safety and efficacy of IMMU-132 in mTNBC patients with two or more prior therapies. This study has been initiated with first patient dosed.
Details of the two presentations are listed below (all times are in Central Time):
Wednesday, December 6, 2017
Thursday, December 7, 2017
On December 6, 2017, Immunomedics will host an investor event at 8:00 pm Central Time at the Grand Hyatt Hotel in San Antonio, TX. Leading the discussion on current mTNBC treatment landscape and the IMMU-132 Phase 2 data will be Linda T. Vahdat, MD, MBA, medical oncologist at Memorial Sloan Kettering Cancer Center and Chief of Medical Oncology and Clinical Director of Cancer Services at Norwalk Hospital, and Harold J. Burstein, MD, PhD, Associate Professor of Medicine at Harvard Medical School, and medical oncologist at Dana-Farber Cancer Institute and Brigham & Women's Hospital. Members of Immunomedics senior management team will also be present to provide a corporate overview and answer questions. For additional information and/or to RSVP for the event, please contact Chau Cheng at email@example.com. The investor event will be webcast via the Investors page on the Company’s website at www.immunomedics.com/investors.shtml. Approximately two hours following the live event, a webcast replay of the event will be available on the Company’s website for approximately 30 days.
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’ most advanced product candidate is IMMU-132 (sacituzumab govitecan), an antibody-drug conjugate that has received Breakthrough Therapy Designation from the FDA for the treatment of patients with metastatic triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics’ primary goal is to bring IMMU-132 to market for the benefit of patients and the creation of stockholder value. 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.
Cautionary note regarding forward-looking statements
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, forecasts of future operating results, potential collaborations, and capital raising activities, timing for bringing any product candidate to market, 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
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