UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 08, 2024 (GLOBE NEWSWIRE) --
Merus N.V. (https://merus.nl/) (Nasdaq: MRUS) (Merus, the Company, we, or our),
a clinical-stage oncology company developing innovative, full-length
multispecific antibodies (Biclonics(®) and Triclonics(®)), today announced that
the first patient has been dosed in the Company's phase 2 trial evaluating
petosemtamab in combination with standard chemotherapy in second line (2L)
metastatic colorectal cancer (mCRC). Petosemtamab is a Biclonics(®) targeting
EGFR and LGR5.
The phase 2, open-label trial will evaluate the safety and preliminary antitumor
of petosemtamab and a regimen of chemotherapy (FOLFIRI or FOLFOX) in 2L mCRC.
The study will enroll approximately 40 patients not previously treated with EGFR
inhibitors and whose tumors do not harbor a KRAS mutation. The level of tumor
EGFR expression will be measured, but the study will not employ a selection
criterion for high EGFR expression.
"We're pleased by the progress we are making across the petosemtamab clinical
development program," said Peter Silverman, Chief Operating Officer.
"Petosemtamab continues to demonstrate meaningful clinical activity in head and
neck cancer, and we are excited by the opportunity to expand into mCRC and
investigate this novel potential treatment for patients struggling with this
devastating disease."
More details of the trial can be found at clinicaltrials.gov
(https://clinicaltrials.gov/study/NCT03526835?intr=petosemtamab&rank=1).
About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics(®) low-fucose human full-length IgG1
antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-
rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is
designed to exhibit three independent mechanisms of action including inhibition
of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and
degradation in cancer cells, and enhanced antibody-dependent cell-mediated
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP)
activity.
About Merus
Merus (https://merus.nl/about/) is a clinical-stage oncology company developing
innovative full-length human bispecific and trispecific antibody therapeutics,
referred to as Multiclonics(®) (https://merus.nl/technology/multiclonics-
platform/). Multiclonics(®) are manufactured using industry standard processes
and have been observed in preclinical and clinical studies to have several of
the same features of conventional human monoclonal antibodies, such as long
half-life and low immunogenicity. For additional information, please visit
Merus' website (https://merus.nl/), X (https://twitter.com/MerusNV) and LinkedIn
(https://www.linkedin.com/company/merus).
Forward-Looking Statements
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 evaluation of petosemtamab in patients with mCRC, the clinical
study design and objectives of the phase 2 study; the progress Merus is making
across the petosemtamab clinical development program; our belief that
petosemtamab continues to demonstrate meaningful clinical activity in Head and
Neck cancer, and the opportunity to expand into mCRC and investigate
petosemtamab in patients having mCRC. 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 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; impacts of the volatility in the global economy,
including global instability, including the ongoing conflicts in Europe and the
Middle East; we may not identify suitable Biclonics(®) or bispecific antibody
candidates under our collaborations or our collaborators may fail to perform
adequately under our collaborations; 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 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 Quarterly Report on Form 10-Q for the period ended March
31, 2024, filed with the Securities and Exchange Commission, or SEC, on May
8, 2024, 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.
Multiclonics(®), Biclonics(®) and Triclonics(®) are registered trademarks of
Merus N.V.
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