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2016-05-04

Merus B.V.: Merus Announces First Patient Dosed in Phase 1/2 Trial Evaluating Bispecific Antibody Candidate MCLA-117 in Patients with AML

UTRECHT, The Netherlands, May 04, 2016 (GLOBE NEWSWIRE) -- Merus B.V., a
clinical-stage immuno-oncology company developing innovative bispecific
antibody therapeutics, announced today that the first patient has been dosed
in the Company's Phase 1/2 clinical trial evaluating MCLA-117 as a potential
treatment of patients with acute myeloid leukemia (AML). MCLA-117 is a
bispecific antibody candidate, which the Company refers to as Biclonics, that
is designed to recruit and activate an AML patient's own T-cells to kill AML
tumor cells and stem cells.

The trial is a single-arm, open-label, multi-national study to assess the
safety, tolerability and anti-tumor activity of MCLA-117. The first phase of
the study is designed as a dose escalation study, followed by a second safety
dose expansion phase. The study will enroll up to 50 evaluable adult AML
patients, who have relapsed or refractory disease and/or are newly diagnosed
patients older than 65 years and are not usually eligible as candidates for
intensive or conventional approved treatments. The primary endpoint is the
safety and tolerability of MCLA-117; secondary endpoints include, among
others, pharmacokinetic measures as well as the anti-tumor response and
clinical benefit of MCLA-117.

"Acute myeloid leukemia is a rapidly-progressing cancer, and little progress
has been made over the past four decades to improve disease-free survival and
overall survival rates in the AML population," said Prof. Gert Ossenkoppele,
hemato-oncologist at the Free University Medical Center, Amsterdam and the
lead investigator of the study. "We are eager to explore MCLA-117 in the
clinic as we continue to expand our understanding of the role of CLEC12A in
AML. Based on the preclinical data observed to date, we believe MCLA-117 is a
promising immunotherapy designed to selectively target leukemic cells and
represents a potential breakthrough in the treatment of AML."

"Initiation of the MCLA-117 clinical program is an important milestone for
this bispecific antibody candidate," said Setareh Shamsili, MD, PhD, Chief
Medical Officer of Merus. "MCLA-117 is designed to bind to CD3, a
cell-surface molecule present on all T-cells, and to CLEC12A, a cell-surface
molecule present on AML tumor cells and stem cells in approximately 90 to 95%
of newly diagnosed and relapsed AML patients. We believe that many patients
with AML could potentially benefit from treatment with MCLA-117."

In preclinical data presented at the 2015 American Society of Hematology
Meeting, MCLA-117 was effective and efficient in killing AML tumor cells by
targeting the CLEC12A molecule, a leukemic stem cell-associated antigen.

About MCLA-117
MCLA-117 is a Biclonics that is designed to bind to CD3 expressed by T-cells
and CLEC12A expressed by acute myeloid leukemia (AML) tumor cells and stem
cells. In preclinical studies, MCLA-117 has been shown to recruit and
activate the immune system's own T-cells to kill AML tumor cells and stem
cells.

About Merus B.V.
Merus is a clinical-stage immuno-oncology company developing innovative
bispecific antibody therapeutics, referred to as Biclonics. Biclonics are
based on the full-length IgG format, are manufactured using industry standard
processes and have been observed in preclinical studies to have several of
the same features of conventional monoclonal antibodies, such as long
half-life and low immunogenicity. Merus' lead bispecific antibody candidate,
MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a
potential treatment for HER2-expressing solid tumors. Merus' second
bispecific antibody candidate, MCLA-117, is being evaluated in a Phase 1/2
clinical trial in Europe as a potential treatment for acute myeloid leukemia.
The Company also has a pipeline of proprietary bispecific antibody candidates
in preclinical development, including MCLA-158, which is designed to bind to
cancer stem cells and is being developed as a potential treatment for
colorectal cancer and other solid tumors, and Biclonics designed to bind to
various combinations of immunomodulatory molecules, including PD-1 and PD-L1.
Contacts:

Merus B.V.
Shelley Margetson - s.margetson@merus.nl
+31 (0)30 253 8800

Argot Partners
Eliza Schleifstein - eliza@argotpartners.com
1-917-763-8106

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus B.V. via Globenewswire

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