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Clinical Collaboration with Yale University to Evaluate Sacituzumab Govitecan in Two Phase 2 Studies in Endometrial and Cervical Cancers
Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced a collaboration with the Yale Cancer Center at the Yale University School of Medicine to evaluate Immunomedics’ lead ADC product candidate, sacituzumab govitecan, as a single agent in two Phase 2 studies in patients with persistent or recurrent endometrial and cervical cancers.
“The treatment of advanced/metastatic endometrial and cervical cancers is challenging and therapeutic options for these patients are limited,” stated the lead investigator of the studies, Alessandro D. Santin, MD, Professor of Obstetrics, Gynecology, and Reproductive Sciences, Yale University School of Medicine, New Haven, CT. “My team has previously reported high Trop-2 expression in endometrial and cervical cancer cell lines, which are highly sensitive to immunotherapy with hRS7, the Trop-2-targeting antibody used in sacituzumab govitecan.”1,2
In addition to the planned Phase 2 studies, Dr. Santin will also be conducting preclinical evaluation of sacituzumab govitecan as a single agent and in combination with poly (ADP-ribose) polymerase (PARP) inhibitors in animal in vivo models of gynecologic cancers.
“The clinical and preclinical evaluation by Dr. Santin and his colleagues at Yale will help guide our path forward in these late-stage gynecologic cancers,” commented Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. “We are committed to using deep scientific insights in expanding the clinical evaluation of sacituzumab govitecan in additional hard-to-treat epithelial cancers.”
Following that principle, the Company has also entered into a research collaboration with the Memorial Sloan Kettering Cancer Center to assess sacituzumab govitecan as a single agent and in combination with epidermal growth factor receptor (EGFR) and phosphoinositide 3-kinase (PI3K) inhibitors, and cisplatin in head and neck cancer in vitro and in vivo models. Furthermore, a separate research collaboration was also established between the Company and Fred Hutchinson Cancer Research Center to investigate sacituzumab govitecan and labetuzumab govitecan (IMMU-130), an ADC that targets CEACAM5, as single agent and in combination in prostate cancer xenograft models.
- Varughese J, Cocco E, Bellone S, et al. Uterine serous papillary carcinomas overexpress human trophoblast-cell-surface marker (Trop-2) and are highly sensitive to immunotherapy with hRS7, a humanized anti-Trop-2 monoclonal antibody. Cancer. 117(14):3163-72, 2011.
- Varughese J, Cocco E, Bellone S, et al. Cervical carcinomas overexpress human trophoblast cell-surface marker (Trop-2) and are highly sensitive to immunotherapy with hRS7, a humanized monoclonal anti-Trop-2 antibody. Am J Obstet Gynecol. 205(6):567.e1-7, 2011.
About Sacituzumab GovitecanSacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.
About ImmunomedicsImmunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. 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 statementsThis 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, including the filing and approval timelines for BLAs and BLA supplements, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the 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.
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