Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the treatment of NRG1+ pancreatic cancer
30 June 2023 - 6:30AM
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company
developing innovative, full-length multispecific antibodies
(Biclonics® and Triclonics®) for cancer, today announced that the
U.S. Food and Drug Administration (FDA) has granted Breakthrough
Therapy Designation (BTD) for zenocutuzumab (Zeno) for the
treatment of patients with advanced unresectable or metastatic NRG1
fusion (NRG1+) pancreatic cancer following progression with prior
systemic therapy or who have no satisfactory alternative treatment
options. This designation for Zeno follows a Fast Track Designation
for the treatment of patients with metastatic solid tumors
harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on
standard of care therapy on January 7, 2021 and Orphan Drug
Designation for the treatment of patients with pancreatic cancer on
July 27, 2020.
BTD is supported by data from the ongoing phase 1/2 eNRGy trial
and Early Access Program (EAP) which are assessing the safety and
anti-tumor activity of Zeno monotherapy in NRG1+ cancer (Phase 1/2:
NCT02912949, EAP: NCT04100694). Data from the eNRGy trial and EAP
were featured as oral presentations during the 2021 and 2022
American Society of Clinical Oncology Annual Meetings (Abstract
#3003, #105 respectively). As of June 1, 2023, more than 175
patients with NRG1+ cancer have been treated with Zeno
monotherapy.
BTD is intended to expedite the development and review of a
medicine to treat a serious or life-threatening condition, where
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement on clinically significant
endpoints over available therapies. BTD allows for more intensive
FDA guidance on an efficient drug development program, an
organizational commitment involving senior managers, and
experienced review staff, as appropriate, in a collaborative,
cross-disciplinary review, and eligibility for rolling review and
priority review. With this BTD, Merus plans to engage in these
discussions with the FDA in an expedited manner, and then provide a
further update on the path and timeline to a potential Biologics
License Application (BLA) submission.
Merus believes that obtaining a commercialization partnership
agreement will be an essential step in bringing Zeno to patients
with NRG1+ cancer, if approved.
“We believe the compelling clinical data for Zeno in NRG1+
cancer, and Breakthrough Therapy Designation, provide the
opportunity to further engage with the FDA to expedite the review
of a potential BLA submission,” said Bill Lundberg, M.D.,
President, Chief Executive Officer of Merus. “Additionally, our
intention to partner Zeno is a reflection of our strategy to
carefully balance value creation with capital allocation
requirements across our portfolio.”
Merus plans to provide a clinical update on Zeno in NRG1+ cancer
at a major medical conference in 2023.
Further, Merus is evaluating Zeno in combination with androgen
deprivation therapy (enzalutamide or abiraterone) in castration
resistant prostate cancer (CRPC), irrespective of NRG1+ status.
Merus plans to provide initial clinical data on Zeno in CRPC in the
second half of 2023. Merus is also evaluating Zeno in combination
with afatinib in patients with NRG1+ NSCLC.
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
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 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, Twitter 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, the
potential benefits of Breakthrough designation for Zeno’s
development for the treatment of patients diagnosed with metastatic
solid tumors harboring NRG1 gene fusions that have progressed on
standard of care therapy or who have no satisfactory alternative
treatment options; Merus’ belief that a obtaining a
commercialization partnership agreement will be an essential step
in bringing Zeno to patients with NRG1+ cancer, if approved; Merus’
belief that clinical data for Zeno in NRG1+ cancer, and
Breakthrough Therapy Designation, provide the opportunity to
further engage with the FDA to expedite the review of a potential
BLA filing; Merus’ intention to partner Zeno and strategy to
carefully balance value creation with capital allocation
requirements across our portfolio; the Zeno clinical study design,
the enrollment of the eNRGy trial, any planned updates on Zeno and
NRG1+ cancer, and Zeno in combination with an ADT for the potential
treatment of CRPC. 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 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; our
registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks; and risks related to
our ceasing to qualify as an emerging growth company and a smaller
reporting company after December 31, 2021.
These and other important factors discussed under the caption
“Risk Factors” in our Annual Report on Form 10-Q for the period
ended March 31, 2023, filed with the Securities and Exchange
Commission, or SEC, on May 4, 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.
Multiclonics®, Biclonics® and Triclonics® 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.
IR/Corp Comms
617-230-4165
k.farren@merus.nl
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