UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 02, 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
updated interim clinical data on MCLA-145 monotherapy and in combination with
pembrolizumab were presented at the 2024 American Society of Clinical
Oncology(®) (ASCO(®)) Annual Meeting taking place in Chicago May 31-June
4, 2024.
"MCLA-145 as monotherapy or with pembrolizumab appears to have a manageable
safety profile and early clinical activity in these difficult to treat cancers.
Our biomarker data suggest that both dose and less frequent administration may
be important determinants of clinical activity, and we are encouraged by the
progress we are making with MCLA-145," said Bill Lundberg, M.D., President,
Chief Executive Officer of Merus. "As our company is now increasingly focused on
our lead asset petosemtamab and plan to initiate phase 3 trials in head and neck
cancer later this year, we aim to advance clinical development of MCLA-145 in
the context of a potential collaboration."
MCLA-145 (CD137 x PD-L1 Biclonics(®)): Solid Tumors
Interim data included in the presentation describe data from patients (pts) with
advanced/metastatic solid tumors who received MCLA-145 Q2W in 28 day cycles or
every three weeks (Q3W) in 21 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 (IO) 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 presentation include:

  * As of a January 3, 2024 data cutoff date, 72 pts with multiple cancer types
    were treated; 25% of pts had non-small cell lung cancer (NSCLC)
      * All patients were heavily pre-treated with a median of 3 prior
        therapies; prior IO in 49% of the monotherapy pts and 100% of the
        combination pts
  * In monotherapy, 52 pts with a variety of tumor types and treated at
    different dose levels were evaluable for response
      * 5 partial responses (PRs) were observed at different dose levels in
        glioblastoma (ongoing as of the cutoff date for >3 years), sarcoma
        (pretreated with pazopanib and gemcitabine/docetaxel), cervical, anal,

and gastric cancer by Response Evaluation Criteria in Solid Tumors v1.1.

        per investigator assessment
      * 2 of 6 pts PRs (33%) were observed for pts treated at the recommended
        dose for expansion (RDE), 40 mg Q3W

* 3 of 6 PRs (50%) were observed for pts with evaluable baseline tumor CD8

        T-cell density of >= 250 cells/mm2 responded
  * In combination with pembrolizumab, 19 pts with a variety of tumor types and
    treated at different dose levels were evaluable for response
      * 1 PR in Merkel cell carcinoma was observed at 25 mg Q3W
      * 1 complete response was observed in PD-L1+ NSCLC at the RDE 40 mg Q3W
      * 3 pts were continuing combination therapy at cutoff date
  * MCLA-145 monotherapy or in combination with pembrolizumab had a well-
    tolerated and manageable safety profile at the RDE, 40mg Q3W
      * Shifting from Q2W to Q3W resulted in a 50% reduction of Grade (G) >=3
        treatment-emergent adverse events in both monotherapy and combination
        therapy
      * Liver toxicity, a common CD137 related adverse event, was controlled
        with no G4 events observed at Q3W

The full presentation is available on the Merus website
(https://merus.nl/technology/publications/).
About Merus
Merus (https://merus.nl/about/) is a clinical-stage oncology company developing
innovative full-length human bispecific and trispecific antibody therapeutics,
referred to as Multiclonics(®) (https://merus.nl/technology/multiclonics-
platform/). 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://merus.nl/), X (https://twitter.com/MerusNV) and LinkedIn
(https://www.linkedin.com/company/merus).
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, 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 Mutliclonics(®); our
belief that for MCLA-145, biomarker data suggest that both dose and less
frequent administration may be important determinants of clinical activity; our
statements concerning the progress we are making with MCLA-145; our increasingly
focus on our lead asset petosemtamab and plan to initiate phase 3 trials in head
and neck cancer later this year; and our aim to advance clinical development of
MCLA-145 in the context of a potential collaboration. 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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