MCLA-145 monotherapy and in combination with pembrolizumab rapid oral session
presentation: June 2, 2024, 11:30 a.m.-1:00 p.m. CT
* MCLA-129 in NSCLC with c-MET exon 14 skipping mutations poster presentation: June 3, 2024, 1:30-4:30 p.m. CT
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) --
Merus N.V. (https://merus.nl/) (Nasdaq: MRUS) (Merus, the Company, we, or our),
a clinical-stage oncology company developing innovative, full-length
multispecific antibodies (Biclonics(®) and Triclonics(®)), today announced the
publication of an abstract regarding MCLA-145 and an abstract regarding MCLA-
129 at the 2024 American Society of Clinical Oncology(®) (ASCO(®)) Annual
Meeting taking place in Chicago May 31-June 4, 2024. Both abstracts can be found
on the 2024 ASCO(®) website. (https://meetings.asco.org/abstracts-
presentations/search?query=*&q=*&sortBy=AbstractBrowse&filters=%7B%22presentatio
nType%22:%5B%7B%22key%22:%22Abstract%22%7D%5D,%22meetingYear%22:%5B%7B%22key%22:
%222024%22%7D%5D,%22meetingTypeName%22:%5B%7B%22key%22:%22ASCO%20Annual%20Meetin
g%22%7D%5D%7D&size=50)
"We continue to be proud of our Multiclonics(®) technology platforms' ability to
develop bispecific antibodies for clinical investigation with the potential to
impact patients' lives," said Bill Lundberg, M.D., President, Chief Executive
Officer of Merus. "MCLA-129 continues to show strong monotherapy activity in
EGFR mutant non-small cell lung cancer, and MCLA-145 is now the fourth molecule
based on our technology to demonstrate clinical activity. We are looking forward
to providing additional detail at 2024 ASCO(®)."
MCLA-145 (CD137 x PD-L1 Biclonics(®)): Solid Tumors
Interim data included in the abstract describe data from patients (pts) with
advanced/metastatic solid tumors who received MCLA-145 as monotherapy every two
weeks (Q2W) in 21 day cycles or every three weeks (Q3W) in 28 day cycles. Pts
treated with the combination of MCLA-145 and pembrolizumab had cancers that
either relapsed after PD-(L)1 therapies or were immunotherapy naïve.
Rapid oral presentation title: Phase I study of MCLA-145, a bispecific antibody
targeting CD137 and PD-L1, in solid tumors, as monotherapy or in combination
with pembrolizumab
Observations in the abstract include:
* As of a December 4, 2023 data cutoff date, 72 pts with multiple cancer types

    were treated; 25% of pts had non-small cell lung cancer (NSCLC); 3 pts were
    continuing combination therapy
  * Monotherapy: 53 pts were treated across 8 dose levels
      * 47 pts 0.4-75 mg Q2W
      * 6 pts 40 mg Q3W
      * The recommended dose for expansion (RDE) was established at 40 mg Q3W
      * In 52 pts evaluable for response
  * 5 partial responses (PRs) were observed in a variety of tumor types
    including: glioblastoma (ongoing>3 years), sarcoma, cervical, anal, and

gastric cancer (treated for 2-11 month (mo)) by Response Evaluation Criteria

    in Solid Tumors (RECIST) v1.1. per investigator assessment
  * Combination: 19 pts were treated with MCLA-145 10, 25 or 40 mg plus
    pembrolizumab Q3W
      * The RDE was established at 40 mg Q3W
      * In 19 pts evaluable for response

* 1 complete response was observed in PD-L1+ NSCLC (treated 6+ mo) and

            1 PR in Merkel cell carcinoma (treated 12+ mo); both after prior
            immunotherapy
          * 68% disease control rate was observed
  * MCLA-145 monotherapy or in combination with pembrolizumab had a well-
    tolerated and manageable safety profile at the RDE of 40 mg Q3W

Presentation Details:
Abstract #: 2520
Session Title: Developmental Therapeutics-Immunotherapy
Session Date and Time: June 2, 2024, 11:30 a.m.-1:00 p.m. CT
MCLA-129 (EGFR x c-MET Biclonics(®)): Solid Tumors
The abstract describes a cohort of patients with advanced/metastatic METex14
NSCLC previously treated with standard therapies, and who were either c-MET TKI-
naïve or who progressed on c-MET TKI.
Safety and efficacy data will be included in the poster presentation at 2024
ASCO(®).
Poster presentation title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET
bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-MET exon 14
skipping mutations (METex14)
Presentation Details:
Abstract #: 8583
Session Title: Lung Cancer-Non-Small Cell Metastatic
Session Date and Time: June 3, 2024, 1:30-4:30 p.m. CT
As full presentations become available at the 2024 ASCO(®) Annual Meeting, they
will contemporaneously be available on the Merus website
(https://merus.nl/technology/publications/).
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, https://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 our clinical candidates, including MCLA-
145 and MCLA-129, future clinical trial results or interim data, clinical
activity and safety profile, and development plans in the on-going trials and
described in forthcoming posters or presentations; the ability of our
Multiclonics(®) platforms' to develop bispecific antibodies for clinical
investigation having potential to impact patients' lives; the future activity of
MCLA-129 in EGFR mutant non-small cell lung cancer or MCLA-145 in solid tumors;
and future development of these assets. We are looking forward to providing
additional detail at 2024 ASCO(®). 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 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-Q for the quarter ended March 31, 2024 filed with
the Securities and Exchange Commission, or SEC, on May 8, 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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