^UTRECHT, Netherlands, and CAMBRIDGE, Massachusetts, April 15, 2023 (GLOBE
NEWSWIRE) — Merus (https://merus.nl/) NV (Nasdaq: MRUS) (Merus, the
Company, we or our), a clinical stage company
Oncology company delivering innovative full-length multispecific antibodies
(Biclonics® and Triclonics®), today announced the release of a
Abstracts for a poster presentation of early clinical data on the bispecific
Antibody petosemtamab in advanced gastric/esophageal adenocarcinoma
at the 2023 American Association for Cancer Research (AACR) Annual Meeting
to be held April 14-19, 2023 in Orlando, Florida.
Petosemtamab or MCLA-158 is a human IgG1 Biclonics® that attaches to cancer cells
binds to the epidermal growth factor receptor (EGFR) and the
Stem cell marker LGR5 (leucine-rich repeat-containing G protein-coupled receptor
5) express.
Petosemtamab is in clinical development in the expansion phase
an open-label, multi-centre phase I/II study in advanced solid
Tumors including advanced gastric/oesophageal adenocarcinoma.
Although petosemtamab has been used in previously treated patients with gastrointestinal
Adenocarcinoma showing EGFR gene amplification and/or overexpression,
The company has shown promising clinical activity
decided to continue clinical exploration of the cohort with gastric
/esophageal adenocarcinoma at this time. The
Company plans to prioritize petosemtamab in squamous cell carcinoma
examine the head and neck because of the strong clinical
activity was observed.
Regarding the information and observations from the cohort of patients with gastric
/esophageal adenocarcinoma treated in the phase I/II study,
belong:
* As of October 24, 2022, 14 previously treated patients with
Gastroesophageal adenocarcinoma every two weeks with petosemtamab 1500 mg
(iv) treated.
* Patient population:
* Median age was 63 years (range 40-80 years); 79%
were male.
* The median value of the previous systemic lines of therapy was
3 (range 1-4); including platinum-based chemotherapy (36% of
patients) and checkpoint inhibitors (14%).
* 14 patients were evaluable for efficacy who had >= 2 treatment cycles
(>= 8 weeks) with >= 1 post-baseline tumor assessment or at
who had early disease progression.
* Antitumor activity of the 14 patients:
* 1 patient with overexpression of the EGFR protein in the tumor and
a gene copy number amplification showed a confirmed persistence
partial response (67% tumor reduction; response after 24
cycles continued).
* 3 patients had stable disease (1 with EGFR-
overexpression and gene copy number amplification; 2 not evaluable
for IHC), with tumor reductions of 2%, 17% and 40%.
* Petosemtamab continues to have a manageable safety profile:
* Out of 78 patients treated with the recommended phase II dose of 1500 mg
were treated every two weeks (escalation and all
expansion cohorts), the most common AEs were independent of the
Causality (All Grades/Grade 3-4) Rash (33%/0%), hypotension
(26%/6%), dyspnea (26%/4%), nausea (26%/1%), acneiform
Dermatitis (24%/1%), blood magnesium deficiency (19%/5%), erythema
(19%/0%), diarrhea (19%/0%); infusion-related reactions
(compound term) were reported in 74%/21% of patients,
mostly on the first infusion and they all went away. 5 patients (6%)
discontinued treatment due to infusion-related reactions
1 off
Details of the lecture:
Title: MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and
LGR5, in advanced gastric/esophageal adenocarcinoma (GEA) [MCLA-158
(Petosemtamab), ein bispezifischer IgG1-Antikörper gegen EGFR und LGR5, bei
fortgeschrittenem Adenokarzinom des Magens und der Speiseröhre]
Session: Phase II Clinical Trials 1
Date: Monday 17 April 2023
Time: 1:30 p.m. – 5:30 p.m. ET
Poster No.: 18
Abstract No: CT156
The summary is on the conference website
(https://www.aacr.org/meeting/aacr-annual-meeting-2023/meeting-resources/).
find.
About petosemtamab?
Petosemtamab or MCLA-158 is a bispecific human IgG1 Biclonics®
Full-length, low-fucose antibody found on the epidermal
Growth factor receptor (EGFR) and LGR5 (leucine-rich repeat containing G-
protein-coupled receptor 5). Petosemtamab is said to have three independent
Mechanisms of action, including inhibition of EGFR-dependent
Signaling, binding of LGR5 leading to internalization and degradation
of the EGFR in cancer cells, as well as increased antibody-dependent
cell-mediated cytotoxicity and antibody-dependent cellular
phagocytic activity.
About Merus NV
Merus (https://merus.nl/about/) is a company in the field of clinical
Oncology, the innovative human bispecific and trispecific antibodies in
full-length, also known as Multiclonics®
(https://merus.nl/technology/multiclonics-platform/) are known. Multiclonics®
are manufactured using industry standard processes. In
preclinical and clinical studies it was observed that several of their
Features with the features of conventional human monoclonal antibodies
are identical, e.g. B. long half-life and low immunogenicity. Further
Information can be found on the Merus website
at https://www.merus.nl, and https://twitter.com/MerusNV.
Forward-Looking Statements
This press release contains forward-looking statements that are considered private
Securities Litigation Reform Act of 1995. All statements in this
Press releases not related to historical facts should be considered as
forward-looking statements are considered, including but not limited to
limited to statements about the clinical development of petosemtamab,
future clinical trials, the company’s decision, the investigation
of petosemtamab in HNSCC patients, which is promising
clinical activity in previously treated patients with gastrointestinal
Adenocarcinoma showing EGFR gene amplification and/or overexpression,
and the decision to discontinue further study of the cohort with gastric
/esophageal adenocarcinoma at this time. This
Forward-looking statements are based on the current expectations of
Management. They are neither promises nor guarantees and are subject to them
known and unknown risks, uncertainties and other important
Factors that may cause our actual results,
Achievements or successes significantly depend on future results, developments
or achievements that are expressed by the forward-looking statements
or implied. These include, but are not limited to: our need for additional
financial resources that may not be available, allowing us to conduct our business
limit or rights to our technologies or to Biclonics®, Triclonics®
and multispecific antibody candidates have to give up; potential
Delays in obtaining regulatory approvals affecting the
Marketing our product candidates and generating
affect sales/profits; the lengthy and expensive process of development
clinical drug with uncertain outcome; the unpredictability of our
Efforts carried out in the pre-clinical phase, marketable medicines
to develop; possible delays in the admission of patients, what the
could adversely affect receipt of required regulatory approvals;
our dependence on third parties to conduct our clinical trials
and the unsatisfactory performance of such third parties; Effects
the COVID-19 pandemic; that we may not have any
identify suitable Biclonics® or bispecific antibody candidates
or that the performance in the context of our cooperation may not
is satisfactory; our dependence on third parties for
Production of our product candidates, which our development and
sales efforts may be delayed, prevented or impaired; Protection
our proprietary technology; our patents may apply to
found invalid or unenforceable, circumvented by competitors, and ours
Patent applications may not be for the rules and regulations
found to satisfy patentability; we may not succeed
existing and potential lawsuits for intellectual infringement
gain property of third parties; our registered or unregistered
Trademarks or trade names may be contested, infringed, circumvented
or declared generic or deemed infringing other trademarks.
These and other important factors are discussed in the “Risk Factors” section of our
Annual Report on Form 10-K for the year ended December 31, 2022
the company on February 28, 2023 with the Securities and Exchange Commission
(SEC) and our other filings with the SEC
Reports listed may lead to actual results
differ materially from the information contained in the forward-looking statements
statements contained in this press release. These future-oriented
Statements reflect management’s beliefs as of the date of the
publication of this press release again. We are entitled, however
undertakes no obligation to update these forward-looking statements to any particular
time to update as appropriate and disclaim any obligation to do so, too
if our views change as a result of future events, unless
this is required by applicable law. Readers will care
cautioned not to place undue reliance on such forward-looking statements
leave, as these apply only to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus
NV
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