Merus N.V. (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 abstracts on the bispecific antibody
MCLA-129 in non-small cell lung cancer (NSCLC) and in previously
treated head and neck squamous cell carcinoma (HNSCC) for
presentation at the European Society for Medical Oncology Congress
(ESMO) Asia Congress 2023 taking place in Singapore December 1-3,
2023.
MCLA-129 is in clinical development in a phase 1/2, open-label
clinical trial evaluating MCLA-129 monotherapy in patients with MET
ex14 NSCLC, and in HNSCC, as well as MCLA-129 in combination with
osimertinib, a third generation EGFR TKI, in patients with
treatment-naïve EGFR mutant (m) NSCLC and in patients with EGFRm
NSCLC that have progressed on osimertinib. Merus has discontinued
enrollment in the exon20 NSCLC cohort due to competitive
reasons.
In addition, an abstract on the bispecific antibody
zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+)
NSCLC was accepted for presentation. This will be an encore of the
upcoming mini-oral presentation that will occur at the ESMO
Congress 2023 in Madrid, Spain.
Merus is currently enrolling patients into the phase 1/2 eNRGy
trial to assess the safety and anti-tumor activity of Zeno
monotherapy in NRG1+ cancer.
Presentations:
Mini-oral presentation:Title:
Efficacy and safety of MCLA-129, an EGFR x c-MET bispecific
antibody, combined with osimertinib, as first-line therapy or after
progression on osimertinib in non-small cell lung cancer
(NSCLC)
Poster presentations: Title:
Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific
antibody, in head and neck squamous cell cancer (HNSCC)
Title: Durable efficacy of zenocutuzumab, a
HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive
(NRG1+) non-small cell lung cancer (NSCLC)
The abstracts will be available on the ESMO Asia Congress
website on Sunday, November 26, 2023 at 11:05 a.m. ET. The
full presentations will be available on the Merus website at the
start of each session.
About MCLA-129MCLA-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 ZenoZeno is an antibody-dependent
cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that utilizes
the Merus Dock & Block® mechanism to inhibit the
neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1
fusions (NRG1+ cancer). Through its unique mechanism of binding to
HER2 and potently blocking the interaction of HER3 with its ligand
NRG1 or NRG1-fusion proteins, Zeno has the potential to be
particularly effective against NRG1+ cancer. In preclinical
studies, Zeno potently inhibits HER2/HER3 heterodimer formation
thereby inhibiting oncogenic signaling pathways, leading to
inhibition of tumor cell proliferation and blocking tumor cell
survival.
About the eNRGy Clinical TrialMerus is
currently enrolling patients in the phase 1/2 eNRGy trial to assess
the safety and anti-tumor activity of Zeno monotherapy in NRG1+
cancer. The eNRGy trial consists of three cohorts: NRG1+ pancreatic
cancer; NRG1+ non-small cell lung cancer; and other NRG1+ cancer.
Further details, including current trial sites, can be found at
www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or
by calling 1-833-NRG-1234.
About Merus N.V.Merus is a clinical-stage
oncology company developing innovative full-length human bispecific
and trispecific antibody therapeutics, referred to as
Multiclonics®. 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 and
https://twitter.com/MerusNV.
Forward-Looking StatementsThis 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 MCLA-129 and zenocutuzumab, 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 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
COVID-19 pandemic; 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-Q for the period
ended June 30, 2023, filed with the Securities and Exchange
Commission, or SEC, on August 7, 2023, 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.
Investor and Media Inquiries:
Sherri SpearMerus N.V.VP Investor Relations and Corporate
Communications617-821-3246s.spear@merus.nl
Kathleen Farren Merus N.V.Corp
Comms/IR617-230-4165k.farren@merus.nl
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