CAMBRIDGE, Mass., Feb. 26, 2018 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology
company focused on biomarker-defined cancers, today announced that
it has dosed the first patient in its SHERBOC study, a
double-blind, placebo-controlled randomized Phase 2 clinical trial
of MM-121 (seribantumab) in patients with heregulin-positive,
hormone receptor-positive and HER2-negative post-menopausal
metastatic breast cancer. MM-121 is a fully human monoclonal
antibody that targets HER3 signaling and is designed to overcome
cancer cells' resistance to the effects of anti-tumor
therapies.
"The SHERBOC study will investigate the treatment of patients
who have progressed on prior therapies, including cyclin-dependent
kinase (CDK) inhibitors, and urgently need additional treatment
options," said J. Marc Pipas, M.D., Merrimack's Senior Medical
Director and Project Leader for MM-121. "This is a crucial next
stage for MM-121's development program, which in prior studies has
shown evidence of activity and tolerability in patients with
heregulin-positive lung, ovarian and breast cancers. The initiation
of enrollment in this study is a significant step forward for our
clinical pipeline, and further advances our biomarker-driven,
precision medicine approach to the treatment of cancer."
The global, multi-site, randomized Phase 2 study will assess
progression-free survival of MM-121, in combination with
fulvestrant, versus a placebo and fulvestrant. The study will
enroll heregulin-positive, hormone receptor-positive and
HER2-negative post-menopausal breast cancer patients who have
progressed after one or two lines of prior systemic therapies for
metastatic or locally advanced disease and have received prior CDK
inhibitor-based therapy. Hormone receptor-positive and
HER2-negative breast cancer comprises three quarters of all breast
cancer diagnoses in the United
States. 1
This study complements several other studies previously
initiated by Merrimack, including the ongoing SHERLOC study in
patients with heregulin-positive non-small cell adenocarcinoma of
the lung who have progressed on a platinum-containing regimen. That
open label, randomized Phase 2 study assessing MM-121 in
combination with docetaxel versus docetaxel alone is expected to
deliver top-line data in the second half of 2018.
The first patient in the SHERBOC study was dosed at the UF
Health Cancer Center at Orlando Health in the United States.
About MM-121
MM-121, also known as seribantumab, is Merrimack's wholly owned,
fully human anti-HER3 (ErbB3) monoclonal antibody that targets
phenotypically distinct heregulin-positive cancer cells within
solid tumors. Heregulin-positive cancer cells are characterized by
their ability to escape the effects of targeted, cytotoxic and
anti-endocrine therapies. Identification of heregulin positive
cancer cells by RNA-ISH may identify tumors at risk for rapid
clinical progression. Seribantumab, when used in the combination
setting, is designed to block the heregulin/HER3 signaling axis to
make these cells more responsive to the effects of the combination
therapy and deliver improved clinical outcomes.
About Merrimack
Merrimack is a biopharmaceutical company based
in Cambridge, Massachusetts that is outthinking cancer to
ensure that patients and their families live fulfilling lives. Its
mission is to transform cancer care through the smart design and
development of targeted solutions based on a deep understanding of
cancer pathways and biological markers. All of Merrimack's
development programs, including four clinical studies and six
candidates in preclinical development, fit into its strategy of 1)
understanding the biological problems it is trying to solve, 2)
designing specific solutions and 3) developing those solutions for
biomarker-selected patients. This three-pronged strategy seeks to
ensure optimal patient outcomes. For more information, please visit
Merrimack's website at www.merrimack.com.
Forward Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts, they are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements include any statements about Merrimack's
strategy, future operations, future financial position, future
revenues and future expectations and plans and prospects for
Merrimack, and any other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue" and similar expressions. In
this press release, Merrimack's forward-looking statements include,
among others, statements about the timing of availability of
clinical trial data. Such forward-looking statements involve
substantial risks and uncertainties that could cause Merrimack's
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the initiation of future clinical trials, availability of data from
ongoing clinical trials, expectations for regulatory approvals,
development progress of Merrimack's companion diagnostics,
availability of funding sufficient for Merrimack's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements, and other matters that could affect the availability
or commercial potential of Merrimack's product candidates or
companion diagnostics. Merrimack undertakes no obligation to update
or revise any forward-looking statements. Forward-looking
statements should not be relied upon as representing Merrimack's
views as of any date subsequent to the date hereof. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to Merrimack's business in
general, see the "Risk Factors" section of Merrimack's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on November 8, 2017
and the other reports Merrimack files with the SEC.
Contact:
Geoffrey Grande, CFA
617-441-7602
ggrande@merrimack.com
1 American Cancer Society. Breast Cancer Facts &
Figures 2015-2016. Atlanta:
American Cancer Society, Inc. 2015.
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SOURCE Merrimack Pharmaceuticals, Inc.