Immunomedics Announces Clinical Collaboration With AstraZeneca in First-Line Triple-Negative Breast and Urothelial Cancers
July 23 2018 - 8:00AM
Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics”
or the “Company”), a leading biopharmaceutical company in the area
of antibody-drug conjugates (ADC), today announced a clinical
collaboration with
AstraZeneca (NYSE:AZN) and its
global biologics research and development arm,
MedImmune, to evaluate the safety and efficacy of
the combination of Imfinzi® (durvalumab), a human monoclonal
antibody directed against PD-L1, and Immunomedics’ lead
antibody-drug conjugate (ADC) product candidate, sacituzumab
govitecan, as a frontline treatment of patients with
triple-negative breast cancer (TNBC) and urothelial cancer (UC).
“We are pleased to be partnering with
AstraZeneca, a global leader in oncology drug development, to
advance sacituzumab govitecan into potential first line of use,
which could benefit a significantly larger patient population,”
said Usama Malik, Chief Business Officer of Immunomedics.
David Berman, Senior Vice President, Head of IO
Franchise, AstraZeneca said, “Our collaboration with Immunomedics
will focus on the combination of sacituzumab govitecan with
Imfinzi® (durvalumab), expanding our efforts in triple-negative
breast cancer and bladder cancer where unmet medical needs still
exist. We believe combining Immunomedics’ antibody-drug conjugate,
a late-stage agent that has demonstrated encouraging clinical
activity, with Imfinzi will complement our existing clinical trial
efforts in this area and maximize benefit to patients.”
Part one of the two-part Phase 1/2 studies will
be co-funded by the two companies. Immunomedics will supply the
study drug and AstraZeneca will utilize its existing clinical trial
infrastructure to accelerate the enrollment of the sacituzumab
govitecan and durvalumab combination. The trial design allows for
rapid transition into randomized Phase 2 studies should the first
part of these studies show promising data and the companies agree
to proceed based on efficacy and safety results obtained.
“The collaboration with AstraZeneca is an
important milestone in our strategy to establish sacituzumab
govitecan as a foundational therapy in TNBC and UC,” commented Dr.
Robert Iannone, Head of Research & Development and Chief
Medical Officer of Immunomedics. “The two agents have different
modes of action, a largely non-overlapping safety profile and are
expected to complement each other in their anticancer activities.
We look forward to working with AstraZeneca to bring sacituzumab
govitecan to cancer patients in earlier lines of therapy.”
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 DurvalumabDurvalumab, a
human monoclonal antibody directed against PD-L1, blocks PD-L1
interaction with PD-1 and CD80 on T cells, countering the tumor’s
immune-evading tactics and inducing an immune response.
As part of a broad development program,
durvalumab is being investigated as monotherapy and in combination
with IO, small molecules, and chemotherapies across a range of
tumors and stages of disease.
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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