Bli medlem
Bli medlem

Du är här

2016-05-04

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

Merus B.V.
Press release

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

UTRECHT, The Netherlands, 2016-05-04 13:00 CEST (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

Författare SSE

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.