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Immunomedics to Fund Phase 2 Study Sponsored by the University of Wisconsin to Enable Further Investigation of Sacituzumab Govitecan in the Treatment of Patients with Castration-Resistant Prostate Cancer (CRPC)
Partnership Underscores Immunomedics’ Strategy to Broaden Development of Sacituzumab Govitecan Beyond Metastatic Triple-Negative Breast Cancer (mTNBC) and Advanced Urothelial Cancer (UC) and Meet High Unmet Medical Need in Patients with Advanced CRPC
MORRIS PLAINS, N.J., Jan. 11, 2018 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today announced a collaboration with the Carbone Cancer Center at the University of Wisconsin, through Immunomedics entering an agreement with The Prostate Cancer Clinical Trials Consortium (PCCTC), to investigate Immunomedics’ lead antibody-drug conjugate (ADC) product candidate, sacituzumab govitecan, in an investigator-sponsored Phase 2 trial in patients with advanced castration-resistant prostate cancer (CRPC).
“The therapeutic landscape for men with CRPC has become limited. With the earlier use of agents such as abiraterone acetate and docetaxel, as well as cross resistance to other FDA approved options, including enzalutamide or cabazitaxel, there is a critical need for new therapeutic agents with unique mechanisms of action,” stated Joshua M. Lang, MD, Assistant Professor, Division of Hematology/Oncology, University of Wisconsin Carbone Cancer Center, Madison, WI, and the lead investigator of the Phase 2 study. “Sacituzumab govitecan is a first-in-class ADC that targets a molecule known as Trop-2 and has shown clinical activity in patients with mTNBC and advanced UC.”
Dr. Lang has previously demonstrated high Trop-2 expression on many types of resistant prostate cancer. In addition to the Phase 2 trial, Dr. Lang will also be leading a broad translational program integrated into the clinical study to further validate the expression and importance of Trop-2 as a therapeutic target in various stages of prostate cancer. A recent $1 million Challenge Award to conduct biomarker work from the Prostate Cancer Foundation will support this comprehensive examination of tumor samples for mutations and gene expression profiles in order to identify molecular pathways associated with Trop-2 expression and resistance development at various clinical disease states.
Through its relationship with PCCTC, Immunomedics is collaborating with the University of Wisconsin to expand these efforts into an investigator-sponsored Phase 2 clinical trial to assess whether targeting Trop-2 with sacituzumab govitecan is promising in prostate cancer patients. Approximately 55-60 male patients with CRPC progressing on enzalutamide or abiraterone, objectively or based on prostate-specific antigen level, in either hormone naïve or CRPC settings will be enrolled into the multicenter study.
“At Immunomedics, we continue to follow our strategic plan to become a fully-integrated biopharmaceutical company, and the exciting partnership with the Carbone Cancer Center is another important step in doing so,” commented Usama Malik, Chief Business Officer of Immunomedics. “We have developed a very robust and multi-faceted clinical development plan for sacituzumab govitecan, and exploring the efficacy and safety of our lead asset in indications beyond mTNBC and advanced UC is a core component of this strategy. Most importantly, advanced CRPC represents an area of high unmet need where we have an opportunity to change the outcome of patients with very limited treatment options.”
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 sacituzumab govitecan (IMMU-132), 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 sacituzumab govitecan to market for the benefit of patients and the creation of stockholder value. For additional information on the Company, please visit its website at https://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.
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
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