CAMBRIDGE, Mass., Sept. 6, 2018 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage
oncology company focused on biomarker-defined cancers, today
announced that it has completed enrollment in its ongoing SHERLOC
study, a Phase 2 clinical trial evaluating its lead investigational
drug candidate, MM-121, in patients with heregulin positive
NSCLC.
"We believe the robust clinical interest we have seen in the
SHERLOC study reflects the significant unmet medical need among
this patient population," said J. Marc Pipas, M.D., Merrimack's
Senior Medical Director and Project Leader for MM-121. "With
gratitude to our team and, of course, to investigators and patients
for their commitment to advancing cancer care, we are pleased to
have achieved this clinical milestone and look forward to reporting
the results from this event-driven study in the coming months."
The SHERLOC study is a global, randomized, biomarker-selected,
open-label Phase 2 clinical trial of MM-121 in combination with
docetaxel, versus docetaxel alone, in patients with heregulin
positive NSCLC. The primary endpoint of the trial is
progression-free survival, with objective response rate, time to
progression and overall survival as key secondary endpoints. Under
the current protocol amendment, the trial enrolled 109 patients
with NSCLC, all of whom underwent a biomarker screen for high tumor
expression of heregulin, the signal for the HER3 receptor that is
prevalent in solid tumors. Patients were also required to have
received a prior platinum-based therapy, as well as prior
immunotherapy where available and clinically indicated. Merrimack
continues to anticipate top-line data from this trial in the second
half of 2018.
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.
In addition to the SHERLOC clinical trial, MM-121 is also being
evaluated in the global, randomized, biomarker-selected,
double-blinded, placebo-controlled, Phase 2 SHERBOC clinical
trial of MM-121 in combination with fulvestrant, versus fulvestrant
alone, in patients with heregulin positive, hormone receptor
positive, ErbB2 (HER2) negative, metastatic breast cancer.
In November 2017, MM-121 was
awarded orphan drug status by the U.S. Food and Drug
Administration (FDA) for the treatment of heregulin positive
NSCLC. This designation may lead to eligibility for a seven-year
period of marketing exclusivity for MM-121 upon approval, as well
as other development assistance and financial incentives.
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 three 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 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
SEC on August 7, 2018 and the other
reports Merrimack files with the SEC.
Contact:
Geoffrey
Grande, CFA
617-441-7602
ggrande@merrimack.com
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SOURCE Merrimack Pharmaceuticals, Inc.