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 interim clinical data, as of a July 31, 2023 data
cutoff date, from the phase 1/2 eNRGy trial and Early Access
Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in
patients with neuregulin 1 fusion (NRG1+) cancer presented by
Principal Investigator, Dr. Alison Schram* of Memorial Sloan
Kettering Cancer Center at the European Society for Medical
Oncology (ESMO) Congress 2023.
“I’ve been impressed by the consistency of the Zeno clinical
data and am convinced Zeno has the potential to be both a first and
best in class treatment for NRG1+ cancer,” said Dr. Andrew Joe,
Chief Medical Officer at Merus. “I expect we will have the dataset
in the first half of 2024 to support potential BLA submissions in
both NRG1+ NSCLC and PDAC.”
Dr. Schram added, “Currently, there are no approved therapies
specifically for the treatment of NRG1+ cancer, resulting in
patients being treated with standard of care by tumor type despite
data suggesting NRG1+ cancers may respond poorly to
chemoimmunotherapy. With Zeno’s durable efficacy and excellent
safety profile reported at ESMO, I believe Zeno could be an
important, new standard of care for patients with NRG1+
cancer.”
The reported data are from the phase 1/2 eNRGy trial and EAP
which are assessing the safety and anti-tumor activity of Zeno
monotherapy in NRG1+ cancer.
Durable efficacy of zenocutuzumab, a HER2 x HER3
bispecific antibody, in advanced NRG1
fusion-positive (NRG1+) non-small cell lung cancer
(NSCLC)
Observations in the presentation include:
- As of July 31, 2023 data cutoff date, 105 patients with NRG1+
NSCLC were treated with Zeno. 78 patients with measurable disease
were treated by February 13, 2023, allowing for the potential for ≥
24 week follow-up, and who met the criteria for the primary
analysis population.
- 37.2% (29/78; 95% Cl: 26.5-48.9) overall response rate (ORR)
per RECIST v1.1 by investigator assessment
- 61.5% (95% CI: 49.8 - 72.3) clinical benefit rate
- 14.9 months median duration of response (DOR) and 20 of
patients were continuing treatment as of the data cutoff
Durable efficacy of zenocutuzumab, a HER2 x HER3
bispecific antibody, in advanced NRG1
fusion-positive (NRG1+) pancreatic ductal
adenocarcinoma (PDAC)
Observations in the presentation include:
- As of July 31, 2023 data cutoff date, 44 patients with NRG1+
PDAC were treated with Zeno. 33 patients with measurable disease
were treated by February 13, 2023, allowing for the potential for ≥
24 weeks follow-up, and who met the criteria for the primary
analysis population.
- 42.4% (95% CI, 25.5–60.8) ORR per RECIST v1.1 by
investigator assessment; 1 (3%) patient achieved a complete
response, and 13 (39%) patients achieved a partial response
- 72.7% (95% CI, 54-87) clinical benefit rate
- 82% experienced tumor reduction
- Of 21 patients evaluable for CA 19-9 levels, 78% showed a ≥ 50%
decrease in CA 19-9 values from baseline
- 9.1 months (95% CI, 5.5–12.0) median DOR; and 6 patients were
continuing treatment as of the data cutoff
Safety findings from both presentations: Zeno
demonstrated a well-tolerated safety profile among the 189 NRG1+
cancer patients who were treated with 750 mg Q2W monotherapy, with
only 6% of patients experiencing related grade 3-4 toxicities.
The full presentations are available on the Publications page of
our website.
*Dr. Schram has financial interests related to Merus.
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 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
gene 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 also potently inhibits HER2/HER3 heterodimer
formation and tumor growth in models harboring NRG1 fusions.
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 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 clinical development of Zeno, future clinical trial
progress, enrollment, results, clinical activity and safety profile
of Zeno in the on-going eNRGy trial and EAP; the potential for Zeno
to be a first in class and best in class for patients with NRG1+
cancer and potential of Zeno to offer an important, potential new
standard of care; our expectation that we will have a dataset to
support potential BLA submissions in both NRG1+ NSCLC and PDAC in
the first half of 2024; and the impact of Zeno’s durable efficacy
and excellent safety profile reported at ESMO on any future
results, including future regulatory interactions or otherwise.
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 clinical development efforts for marketable drugs;
potential delays in enrollment of patients, and our reliance on
third parties to conduct our clinical trials, manufacturing and
accompanying activities for clinical drug development and potential
approval and the potential for those third parties to not perform
satisfactorily, which could affect the receipt of necessary
regulatory approvals; impacts of the COVID-19 pandemic and global
instability; 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 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.
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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