Merus Provides Clinical Updates for MCLA-117 and MCLA-158 Programs
January 04 2018 - 7:00AM
YASTEST
- IND submitted
to U.S. FDA for MCLA-117 in AML -
- First CTA
approval for MCLA-158 received in European country -
UTRECHT, The Netherlands, Jan. 04,
2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a
clinical-stage immuno-oncology company developing innovative
bispecific antibody therapeutics (Biclonics®), today
announced the submission of an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration (FDA) for
MCLA-117 for the potential treatment of acute myeloid leukemia
(AML) and the approval of a Clinical Trial Application (CTA) in
Belgium for MCLA-158 for the potential treatment of metastatic
colorectal cancer.
"The filing of an IND for MCLA-117
and the first CTA approval for MCLA-158 represent key steps forward
for both programs as we continue to progress our robust pipeline of
proprietary bispecific antibodies in the clinic with the goal of
addressing significant unmet medical needs," said Ton Logtenberg,
Ph.D., Chief Executive Officer of Merus. "We look forward to the
advancement of both Biclonics® in 2018,
including the initiation a Phase 1 first-in-human trial of MCLA-158
in Belgium planned for this quarter."
Merus today announced that it has
submitted an IND application to the U.S. FDA for MCLA-117, the
Company's T-Cell Engager Biclonics®, designed to
specifically bind to CD3, a cell-surface molecule present on T
cells, and CLEC12A, a cell-surface molecule present on AML cells
and stem cells. MCLA-117 is currently being studied in an ongoing
Phase 1, first-in-human, dose escalation clinical trial in Europe
in AML patients with relapse or refractory disease. Upon
acceptance of the IND by the U.S. FDA, Merus plans to open sites
for this trial in the United States.
The Company also announced
approval of a CTA in Belgium, one of the several European
countries where Merus has filed a CTA and where it plans to first
initiate a Phase 1, first-in-human clinical trial of MCLA-158.
MCLA-158 is an ADCC-enhanced Biclonics® designed
to bind to cancer stem cells expressing leucine-rich
repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal
growth factor receptors (EGFR). The trial, which will focus
initially in patients with metastatic colorectal cancer, is
anticipated to start during the first quarter of 2018. Merus plans
to file an IND for MCLA-158 with the U.S. FDA in the first quarter
of 2018.
About Merus N.V.
Merus is a clinical-stage
immuno-oncology company developing innovative full-length human
bispecific antibody therapeutics, referred to as
Biclonics®.
Biclonics®, which are
based on the full-length IgG format, are manufactured using
industry standard processes and have been observed in preclinical
studies to have similar features as conventional monoclonal
antibodies, such as long half-life and low immunogenicity. Merus'
most advanced bispecific antibody candidate, MCLA-128, is expected
to soon be evaluated in a Phase 2 combination trial in two
metastatic breast cancer populations. MCLA-128 is also being
evaluated in a Phase 1/2 clinical trial in Europe in gastric,
ovarian, endometrial and non-small cell lung cancers. Merus' second
most advanced bispecific antibody candidate, MCLA-117, is being
developed in a Phase 1 clinical trial in patients with acute
myeloid leukemia. The Company also has a pipeline of proprietary
bispecific antibody candidates in preclinical development,
including MCLA-158, which is designed to bind to cancer stem cells
and is being developed as a potential treatment for colorectal
cancer and other solid tumors, as well as MCLA-145, which is
designed to bind to PD-L1 and a non-disclosed second
immunomodulatory target and is being developed in collaboration
with Incyte Corporation. For additional information, please visit
Merus' website, www.merus.nl.
Forward
Looking Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation statements regarding the progress of Merus'
robust pipeline of proprietary bispecific antibodies in the clinic
with the goal of addressing significant unmet medical needs, the
advancement of MCLA-117 and MCLA-158 through 2018, including the
timing of initiating clinical trials, plans to open sites in the
U.S. for the ongoing Phase 1 clinical trial of MCLA-117, the
initial focus on metastatic colorectal cancer for the Phase 1
clinical trial for MCLA-158 and filing an IND in the U.S. for
MCLA-158 in the first quarter of 2018, the timing of the Phase 2
combination trial of MCLA-128 in metastatic breast cancer and the
potential of MCLA-158 to treat colorectal cancer and other solid
tumors.
These forward-looking statements
are based on management's current expectations. These statements
are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: our need for additional funding,
which may not be available and which may require us to restrict our
operations or require us to relinquish rights to our technologies
or Biclonics® and
bispecific antibody candidates; potential delays in regulatory
approval, which would impact our ability to commercialize our
product candidates and affect our ability to generate revenue; the
lengthy and expensive process of clinical drug development, which
has an uncertain outcome; the unpredictable nature of our early
stage development efforts for marketable drugs; potential delays in
enrollment of patients, which could affect the receipt of necessary
regulatory approvals; our reliance on third parties to conduct our
clinical trials and the potential for those third parties to not
perform satisfactorily; we may not identify suitable
Biclonics® or
bispecific antibody candidates under our collaboration with Incyte
or Incyte may fail to perform adequately under our collaboration;
our reliance on third parties to manufacture our product
candidates, which may delay, prevent or impair our development and
commercialization efforts; protection of our proprietary
technology; our patents may be found invalid, unenforceable,
circumvented by competitors and our patent applications may be
found not to comply with the rules and regulations of
patentability; we may fail to prevail in existing and potential
lawsuits for infringement of third-party intellectual property; and
our registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks.
These and other important factors
discussed under the caption "Risk Factors" in our Annual Report on
Form 20-F filed with the Securities and Exchange Commission, or
SEC, on April 28, 2017, and our other reports filed with the SEC,
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change, except as required under
applicable law. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
Contacts:
Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly@argotpartners.com
Media:
David Rosen
+1 212-600-1902
david.rosen@argotpartners.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Merus N.V. via Globenewswire
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