CAMBRIDGE, Mass., June 25, 2018 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage
oncology company focused on biomarker-defined cancers, today
announced top-line results from the CARRIE study, a randomized
Phase 2 trial evaluating the addition of MM-141 (istiratumab) to
standard-of-care treatment in patients with previously untreated
metastatic pancreatic cancer and high serum levels of free
Insulin-like Growth Factor-1 (IGF-1). The study did not meet its
primary or secondary efficacy endpoints in patients who received
MM-141 in combination with nab-paclitaxel and gemcitabine, compared
to nab-paclitaxel and gemcitabine alone. These results were
consistent in all subgroups analyzed. Based on these results,
Merrimack will not devote additional resources to the development
of MM-141.
Merrimack plans to present the complete data from this Phase 2
study at an upcoming medical oncology meeting.
"Pancreatic cancer is the third leading cause of cancer-related
death in the Unites States and a very difficult cancer to treat,"
said Sergio Santillana, M.D., MSc.,
Chief Medical Officer of Merrimack. "Although we were unsuccessful
in our effort to improve the standard of care for these patients,
we want to express our gratitude to our investigators and our team,
and, of course, to the patients and their families for their
support and participation in the CARRIE study."
"While these results are disappointing, looking forward our
focus remains on the continued development of our deep,
wholly-owned pipeline, including two clinical programs, MM-121 and
MM-310, with data readouts expected in 2018," said Richard Peters, M.D., Ph.D., President and CEO
of Merrimack.
MM-121 (seribantumab), a monoclonal antibody targeting the HER3
(ErbB3) receptor, is being tested in combination with
standard-of-care treatment in two randomized Phase 2 studies:
SHERLOC, in patients with non-small cell lung cancer, and SHERBOC
in patients with metastatic breast cancer. Both studies are
enrolling patients with high tumor expression of heregulin, the
signal for the HER3 receptor. Top-line results from the SHERLOC
study are expected in 2H 2018.
MM-310, an antibody-directed nanotherapeutic targeting the EphA2
receptor, is currently being tested in a Phase 1 study in solid
tumors, with safety data and the maximum tolerated dose expected in
2H 2018.
About Merrimack's Phase 2 CARRIE Study
The CARRIE study is a global, double-blinded,
placebo-controlled, randomized Phase 2 trial, evaluating MM-141 in
patients with previously untreated metastatic pancreatic cancer.
Prior to enrollment, patients were screened for high serum levels
of free IGF-1, a prevalent biomarker in approximately 50% of
patients with pancreatic cancer that is believed to be associated
with more aggressive forms of the disease. The trial enrolled 88
patients who were randomized 1:1 to treatment and control arms to
assess MM-141, in combination with the standard-of-care
chemotherapy (nab-paclitaxel and gemcitabine), versus chemotherapy
plus placebo. The primary endpoint of the study is progression-free
survival, while secondary endpoints include objective response
rate, disease control rate, duration of response, overall survival
and safety. Merrimack initiated the CARRIE study in May 2015 and completed enrollment in June 2017.
About MM-141
MM-141 (istiratumab) is Merrimack's wholly owned, fully human,
bispecific, tetravalent monoclonal antibody, targeting receptor
complexes containing the Insulin Like Growth Factor 1 Receptor
(IGF-1R) and ErbB3 (HER3) cell surface receptors to block tumor
survival signals. IGF-1R and HER3 complexes cooperate to activate
the PI3K/AKT/mTOR pathway, a major signaling pathway that allows
tumor cells to grow and develop resistance to chemotherapy. MM-141
is designed to suppress the PI3K/AKT/mTOR pathway by binding to
both the IGF-1R and HER3 receptors.
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 use of Merrimack's resources and
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 May 8, 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.