Petosemtamab in combination with pembrolizumab in 1L HNSCC initial interim

           clinical data selected for rapid oral session presentation
  MCLA-145 as monotherapy or in combination with pembrolizumab in solid tumors
   initial interim clinical data selected for rapid oral session presentation

MCLA-129 in NSCLC with c-MET exon 14 skipping mutations initial interim clinical
data selected for poster presentation
UTRECHT, The Netherlands and CAMBRIDGE, Mass., April 24, 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 the
acceptance of three abstracts for presentation at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois on May
31- June 4, 2024.
Rapid oral presentation:
Title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment
of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC):
Phase 2 study
Abstract #: 6014
Session Title: Head and Neck Cancer
Session Date and Time: June 3, 2024, 8:00-9:30 a.m. CT
The presentation concerns petosemtamab evaluated in combination with
pembrolizumab in patients with untreated advanced PD-L1+ HNSCC.
Rapid oral presentation:
Title: Phase I study of MCLA-145, a bispecific antibody targeting CD137 and PD-
L1, in solid tumors, as monotherapy or in combination with pembrolizumab
Abstract #: 2520
Session Title: Developmental Therapeutics-Immunotherapy
Session Date and Time: June 2, 2024, 11:30 a.m.-1:00 p.m. CT
The presentation concerns MCLA-145 evaluated as monotherapy or in combination
with pembrolizumab in patients with solid tumors.
Poster presentation:
Title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody,
in non-small-cell lung cancer (NSCLC) with c-MET exon 14 skipping mutations
(METex14)
Abstract #: 8583
Session Title: Lung Cancer-Non-Small Cell Metastatic
Session Date and Time: June 3, 2024, 1:30-4:30 p.m. CT
The presentation concerns MCLA-129 evaluated as monotherapy in patients with
locally advanced/metastatic METex14 NSCLC.
The abstracts will be available on the ASCO website
(https://conferences.asco.org/am/program) on May 23, 2024 at 5:00 p.m. ET. The
full presentations will be available on the Merus website
(https://merus.nl/technology/publications/) at the start of each session.
About Petosemtamab
Petosemtamab, or MCLA-158, is a bispecific 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 MCLA-145
MCLA-145 is a Biclonics(®) T-cell agonist that binds with high affinity and
specificity to human PD-L1 and CD137 in preclinical models. The unique
immunostimulatory profile of MCLA-145 derives from the potential to potently
activate immune effector cells in the context of the tumor microenvironment
while blocking inhibitory signals among T-cells within the same immune cell
population.
About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics(®)
that is designed to inhibit the EGFR and c-MET signaling pathways in solid
tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-
resistant NSCLC in xenograft models of cancer. MCLA-129 is designed to have two
complementary mechanisms of action: blocking growth and survival pathways to
stop tumor expansion and recruitment and enhancement of immune effector cells to
eliminate the tumor.
About Merus N.V.
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 (http://www.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 clinical development of petosemtamab, MCLA-145 and MCLA-129,
future clinical trial results or interim data, clinical activity and safety
profile in the on-going trials and planned abstracts and presentation. These
forward-looking statements are based on management's current expectations. 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(®), Triclonics(®) and multispecific 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 market volatility; 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 Annual Report on Form 10-K for the year ended December 31, 2023 filed with
the Securities and Exchange Commission, or SEC, on February 28, 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.
Biclonics(®), Triclonics(®) and Multiclonics(®) are registered trademarks of
Merus N.V.
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