UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 03, 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 a poster regarding MCLA-129 presented at the 2024 American
Society of Clinical Oncology(®) (ASCO(®)) Annual Meeting taking place in Chicago
May 31-June 4, 2024.
"These data continue to support our view that MCLA-129 is a very active drug,
and that our Biclonics(®) platform really can create clinically active drugs for
patients with cancer. We plan to start a cohort investigating MCLA-129 in
combination with chemotherapy in 2L+ EGFRm NSCLC later this year," said Bill
Lundberg, M.D., President, Chief Executive Officer of Merus. "We continue to
evaluate MCLA-129 with a focused investment and remain interested in a
partnership to resource the further development of this asset."
Poster presentation title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET
bispecific antibody, in non-small-cell lung cancer (NSCLC) with Hepatocyte
Growth Factor Receptor (c-MET) exon 14 skipping mutations (METex14)
Observations in the presentation include:

  * As of a February 16, 2024 data cutoff date, 22 patients (pts) were treated
    and 14 pts (64%) were continuing treatment
      * All the pts received MCLA-129 in monotherapy at the dose of 1500 mg,
        every 2 weeks
      * Pts received a median of 2 lines of prior therapy

* 10 pts (45%) were tyrosine kinase inhibitor (TKI)-naïve and 12 (55%) had

        received prior TKIs
      * 7 pts were excluded from the efficacy population. 4 discontinued due to
        AEs =2 treatment cycles,
    measurable disease at baseline and >=1 post-baseline scan
      * Response rate overall: 3 partial responses (PRs) and 6 unconfirmed PRs
        (uPRs) were observed by Response Evaluation Criteria in Solid Tumors
        v1.1 per investigator assessment; 5 of the 6 uPRs were confirmed and 1
        uPR progressed after the data cutoff (8/15 confirmed PRs (53%))

* 6 of 8 TKI-naïve cancers responded, one of which was an initial uPR that

        progressed after data cutoff
      * 3 of 7 cancers with prior MET TKI responded
      * Reduction in target lesion tumor size from baseline was demonstrated in
        12 pts (80%)

* Early safety assessment in 22 pts treated with MCLA-129 monotherapy included

      * Infusion related reactions (composite term) in 86% (18% >= Grade (G)3)
      * One pt had treatment-related interstitial lung disease (G2)
      * Venous thromboembolism was recorded in 2 pts (1 G3 possibly treatment-
        related, the other G2 and not related to treatment)

The full presentation is available on the Publications page of our website
(https://merus.nl/technology/publications/).
MCLA-129 is subject to a collaboration and license agreement with Betta
Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 and
potentially commercialize exclusively in China, while Merus retains global
rights outside of China. An abstract sponsored by Betta entitled: Efficacy and
safety of MCLA-129, an EGFR/c-MET bispecific antibody, in advanced non-small
cell lung cancer (NSCLC) was accepted for poster presentation at 2024 ASCO(®).
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-
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 Mutliclonics(®)
platforms; our belief that these data continue to support our view that MCLA-
129 is a very active drug for patients with cancer; our plans to start a cohort
investigating MCLA-129 in combination with chemotherapy in 2L+ EGFR mutant NSCLC
in 2024; and our continued evaluation MCLA-129 with a focused investment and
interest in a partnership to resource the further development of this asset.
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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