Merus and Partner Therapeutics Announce License Agreement for the U.S. Commercialization of Zenocutuzumab in NRG1 Fusion-Positive Cancer
03 December 2024 - 12:00AM
UK Regulatory
Merus and Partner Therapeutics Announce License Agreement for the
U.S. Commercialization of Zenocutuzumab in NRG1 Fusion-Positive
Cancer
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec.
02, 2024 (GLOBE NEWSWIRE) -- 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 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 patients with certain
cancer types including NSCLC and PDAC.
About Partner Therapeutics
Partner 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.
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