Merus and Partner Therapeutics Announce License Agreement for the U.S. Commercialization of Zenocutuzumab in NRG1 Fusion-Positive Cancer
02 Dezembro 2024 - 10:00AM
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®) and Partner
Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology
company with a focus in hematology and oncology, today announced
they have entered into an agreement in which Merus has exclusively
licensed to PTx the right to commercialize zenocutuzumab (Zeno) for
the treatment of NRG1 fusion-positive (NRG1+) cancer in the United
States (U.S.).
“We are thrilled to work with the seasoned team at PTx to
advance our mission to bring Zeno to patients with NRG1+ cancer,”
said Shannon Campbell, Chief Commercial Officer of Merus. “We
believe PTx is an ideal partner to support Zeno given their
oncology commercialization expertise and executive team’s deep
understanding and experience with NRG1+ cancer.”
“Zeno has the potential to be the first and only targeted
therapy for patients with NRG1+ non-small cell lung and pancreatic
cancer, and may offer a substantial improvement over currently
available therapies,” said Sarah Kurz, President and Chief
Operating Officer of PTx. “ We are grateful to Merus for their
development of Zeno, which has the potential to fill an unmet
medical need for these patients.”
Under the terms of the agreement, following a specified
transition period, PTx will assume full rights to U.S.
commercialization of Zeno for the treatment of NRG1+ cancer. In
exchange for the rights granted under the license agreement, Merus
will receive an upfront payment and is eligible to receive
milestones and high single-digit to low double-digit royalty
payments based on the annual net sales of Zeno in NRG1+ cancer in
the U.S. for any potential future sales.
A Biologics License Application for Zeno is currently under
review by the U.S. Food and Drug Administration for the treatment
of patients with previously treated NRG1+ non-small cell lung
cancer and pancreatic cancer.
About ZenoZeno 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 FusionsThe 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 patients with certain cancer types including NSCLC and
PDAC.
About Partner TherapeuticsPartner Therapeutics,
Inc. (PTx), an integrated biotechnology company, focuses on
development and commercialization of therapeutics to improve health
outcomes in cancer and other serious diseases. The company
believes in delivering products and supporting medical teams with
the purpose of achieving superior outcomes for patients and their
families. Visit www.partnertx.com.
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 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, benefits
of a license between PTx and Merus; whether and when Merus will
receive any future payment under the license agreement, including
milestones or royalties, and the amounts of such payments; our
belief that PTx is an ideal partner to support Zeno; Zeno’s
potential to be the first and only targeted therapy for patients
with NRG1+ lung and pancreatic cancer, and potential to offer a
substantial improvement over currently available therapies and to
fill an unmet medical need for patients with NRG1+ cancer. 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 September 30, 2024, filed with the Securities and Exchange
Commission, or SEC, on October 31, 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.
Investor and Media Inquiries:
Partner Therapeutics Media Relations
781-786-2405
media.relations@partnertx.com
Sherri Spear
Merus N.V.
SVP Investor Relations and Strategic Communications
617-821-3246
s.spear@merus.nl
Kathleen Farren
Merus N.V.
Associate Director Investor Relations and Corporate Communications
617-230-4165
k.farren@merus.nl
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