CAMBRIDGE, Mass. and
BANNOCKBURN, Ill., May 19, 2016 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (Nasdaq: MACK) and Baxalta Incorporated
(NYSE: BXLT) today jointly announced the initiation of a Phase 1
clinical study of Merrimack's oligoclonal EGFR (epidermal growth
factor receptor) inhibitor, MM-151, in combination with ONIVYDE®
(irinotecan liposome injection) plus fluorouracil (5-FU) and
leucovorin in patients with RAS wild-type metastatic colorectal
cancer. Data from a prior Phase 1 study of MM-151 supports further
clinical evaluation of the investigational therapy in patients with
metastatic colorectal cancer. The initiation of this study advances
the development path for ONIVYDE.
"Metastatic colorectal cancer remains a deadly disease with only
11% of patients surviving five years or longer," said Dr.
Emily Chan, Principal Investigator,
Associate Professor of Medicine and GI Medical Oncologist,
Vanderbilt-Ingram Cancer Center. "As our understanding of the
dynamics of cancer cells increases, we are able to develop and
explore novel targeted combination therapies to combat this deadly
disease. This study is a significant step forward toward addressing
this unmet medical need, and providing a potential new treatment
option to patients facing this deadly disease."
This Phase 1 study will assess the safety and tolerability of
the combination of MM-151, a novel antibody mixture of three human
antibodies designed to target EGFR which promotes tumor growth, and
ONIVYDE, also known as MM-398 or "nal-IRI," plus 5-FU and
leucovorin as first or second-line treatment in patients with RAS
wild-type metastatic colorectal cancer.
"We are excited to initiate this Phase 1 clinical study, which
will enable us to evaluate MM-151 in combination with the ONIVYDE
regimen," said J. Marc Pipas, M.D., Medical Director at Merrimack.
"Preclinically, MM-151 has shown superior inhibition of the EGFR
pathway compared to FDA approved EGFR inhibitors. Combining MM-151
with the ONIVYDE regimen represents an exciting opportunity to
investigate a potential new treatment regimen for patients with
metastatic colorectal cancer."
The trial will determine the side effect profile of MM-151 in
combination with ONIVYDE plus 5-FU and leucovorin and recommended
dose for subsequent trials with this combination. Eligible patients
for the study must have metastatic disease, have had no prior
exposure to irinotecan or an EGFR inhibitor, and have received no
more than one prior line of treatment for metastatic disease.
Merrimack plans to conduct the study at multiple sites in
the United States. Merrimack will
be solely responsible for the funding and execution of the Phase 1
study. For more information, please visit
www.clinicaltrials.gov.
Merrimack and Baxalta have entered into an exclusive licensing
agreement to develop and commercialize ONIVYDE outside of
the United States. PharmaEngine,
Inc. (Taipei, Taiwan) holds the
rights to commercialize ONIVYDE in Taiwan and received the Taiwan FDA approval of
ONIVYDE on October 22, 2015.
About MM-151
MM-151 is Merrimack's wholly owned oligoclonal therapeutic
mixture consisting of three fully-human monoclonal antibodies
designed to bind and inhibit signaling of the epidermal growth
factor receptor (EGFR). EGFR-mediated signaling promotes the growth
and survival of cancer cells and has long been recognized as an
important drug target in several types of cancer, including colon,
lung, breast, pancreatic, and head and neck cancers. MM-151 has
previously been tested in a Phase 1 dose-escalation clinical trial
in patients with advanced solid tumors.
About ONIVYDE® [pronounced 'on - ih - vide ]
ONIVYDE® (irinotecan liposome injection), also known as MM-398
or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal
formulation. The activated form of irinotecan is SN-38, which
functions by inhibiting topoisomerase I (an essential enzyme
involved in DNA transcription and replication) and promoting cell
death. ONIVYDE was approved by the U.S. Food and Drug
Administration in combination with fluorouracil and leucovorin for
the treatment of patients with metastatic adenocarcinoma of the
pancreas after disease progression following gemcitabine-based
therapy. For full prescribing information, including Boxed
WARNING, please visit www.ONIVYDE.com.
About Merrimack
Merrimack is a fully integrated biopharmaceutical company that
views cancer as a complex engineering challenge. Through systems
biology, which brings together the fields of biology, computing and
engineering, Merrimack aims to decrease uncertainty in drug
development and clinical validation, and move discovery efforts
beyond trial and error. Such an approach has the potential to make
individualized treatment of patients a reality. Merrimack's first
commercial product, ONIVYDE® (irinotecan liposome injection), was
approved by the U.S. FDA in October
2015. With four additional candidates in clinical studies,
several in preclinical development and multiple biomarkers designed
to support patient selection, Merrimack is building one of the most
robust oncology pipelines in the industry. For more information,
please visit Merrimack's website at www.merrimack.com or connect on
Twitter at @MerrimackPharma.
About Baxalta Incorporated
Baxalta Incorporated (NYSE: BXLT) is a $6
billion global biopharmaceutical leader developing,
manufacturing and commercializing therapies for orphan diseases and
underserved conditions in hematology, oncology and immunology.
Driven by passion to make a meaningful impact on patients' lives,
Baxalta's broad and diverse pipeline includes biologics with novel
mechanisms and advanced technology platforms such as gene therapy.
The Baxalta Global Innovation and R&D Center is located in
Cambridge, Massachusetts. Launched
in 2015 following separation from Baxter International Inc.,
Baxalta's heritage in biopharmaceuticals spans decades. Baxalta's
therapies are available in more than 100 countries and it has
advanced biological manufacturing operations across 12 facilities,
including state-of-the-art recombinant production and plasma
fractionation. Headquartered in Northern
Illinois, Baxalta employs 16,000 employees worldwide.
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 potential effectiveness and
safety profile of MM-151 in combination with the ONIVYDE regimen
and Merrimack's ability to translate clinical data into future
clinical success. 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 products, 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 Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on February 26, 2016
and other reports Merrimack files with the SEC.
CONTACTS:
Media Contact:
Marianne McMorrow
774-776-1478
mmcmorrow@merrimack.com
Investor Contact:
Geoffrey Grande, CFA
617-441-7602
ggrande@merrimack.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/merrimack-and-baxalta-announce-initiation-of-phase-1-study-of-mm-151-in-combination-with-the-onivyde-irinotecan-liposome-injection-regimen-in-metastatic-colorectal-cancer-300271334.html
SOURCE Merrimack Pharmaceuticals, Inc.