Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC
2024年5月7日 - 5:05AM
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 that the U.S. Food and Drug Administration (FDA) has
accepted for priority review a Biologics License Application (BLA)
for the bispecific antibody zenocutuzumab (Zeno) in patients with
neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+
pancreatic (PDAC) cancer.
“FDA acceptance of our first BLA represents an important
achievement for Merus and an important potential treatment
opportunity for patients with NRG1+ cancer, a disease with poor
prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical
Officer at Merus. “Zenocutuzumab has the potential to be the first
and only targeted therapy for patients with NRG1+ lung and
pancreatic cancer, and may offer a substantial improvement
over currently available therapies.”
The BLA includes a comprehensive clinical data package,
including data from the phase 1/2 eNRGy trial, which is
investigating the safety and anti-tumor activity of Zeno
monotherapy in NRG1+ NSCLC, PDAC and other solid tumors. Data from
the open-label trial were presented previously at the American
Society of Clinical Oncology (ASCO) 2021 Annual Meeting, and
subsequently updated at ASCO 2022 and the European Society for
Medical Oncology (ESMO) Congress 2023.
The FDA has granted Breakthrough Therapy Designation (BTD) to
Zeno for the treatment of patients with advanced unresectable or
metastatic NRG1+ pancreatic cancer following progression with prior
systemic therapy or who have no satisfactory alternative treatment
options. Additionally, the FDA has granted BTD to Zeno for the
treatment of patients with advanced unresectable or metastatic
NRG1+ NSCLC, following progression with prior systemic therapy.
Zeno is currently under clinical development, and its safety and
efficacy have not been fully evaluated by any regulatory
authority.
About Zeno
Zeno is a 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. In clinical studies, Zeno has demonstrated anti-tumor
activity in multiple types of NRG1+ cancer, including NRG1+ NSCLC
and NRG1+ PDAC.
About NRG1 Fusions
The NRG1 gene encodes neuregulin (also known as heregulin), the
ligand for HER3. Fusions between NRG1 and partner genes are rare,
tumorigenic genomic events occurring in certain cancer types
including NSCLC and PDAC.
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, X and LinkedIn.
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 cost and timing of our product development activities
for Zeno, the advancement of our clinical trials and our ability to
successfully advance our Zeno through the regulatory and potential
commercialization processes, the potential of Zeno as a treatment
opportunity for patients with NRG1+ cancer and to be the first and
only targeted therapy for patients with NRG1+ lung and
pancreatic cancer, the potential of Zeno to provide a
substantial improvement over currently available therapies.
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.
Investor and Media Inquiries:
Sherri Spear
Merus N.V.
VP Investor Relations and Corporate Communications
617-821-3246
s.spear@merus.nl
Kathleen Farren
Merus N.V.
Corp Comms/IR
617-230-4165
k.farren@merus.nl
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