Immunomedics Announces Multiple Clinical and Preclinical Collaborations With Prominent Cancer Research Institutions
July 30 2018 - 8:00AM
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.
References
- 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.
For More Information:
For Investor Inquiries:Dr. Chau
ChengSenior Director, Investor Relations & Corporate
Secretary(973) 605-8200, extension 123ccheng@immunomedics.com
For Media
Inquiries:media@immunomedics.com
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