Immunomedics Announces Agreement with University of Wisconsin Carbone Cancer Center to Expand Sacituzumab Govitecan (IMMU-132...
January 11 2018 - 8:00AM
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)
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.”
About ImmunomedicsImmunomedics
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 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, 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.
Investor
Contact:Dr. Chau ChengSenior Director, Investor
Relations & Corporate Secretary(973) 605-8200, extension
123ccheng@immunomedics.com
Media Contact:Dan Zacchei /
Josh HochbergSloane & Company212-486-9500
Dzacchei@sloanepr.comJhochberg@sloanepr.com
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