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Merus N.V. Signs Commercial Multi-Product License for ProBioGen’s GlymaxX® ADCC Enhancement

Merus N.V.

Merus N.V. Signs Commercial Multi-Product License for ProBioGen’s GlymaxX® ADCC

Bispecific Cancer Antibody Pipeline Optimized by GlymaxX® Manufacturing

BERLIN & UTRECHT, The Netherlands, 2016-06-01 13:43 CEST (GLOBE NEWSWIRE) --
ProBioGen AG and Merus N.V. (Nasdaq:MRUS) today jointly announced that Merus
has signed a commercial multi-product license agreement for ProBioGen’s
GlymaxX® ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) enhancement
technology. Under the terms of the agreement, Merus has obtained non-exclusive
use of GlymaxX® technology for Merus’ Biclonics® pipeline of bispecific cancer
antibodies to enhance their ADCC activity. Financial details of the license
agreement were not disclosed.

MCLA-158 is the first GlymaxX®-modified ADCC-enhanced bispecific antibody being
developed under this commercial license. MCLA-158 is being developed as a
potential treatment for colorectal cancer and other types of solid tumors. The
compound is designed to bind to cancer stem cells that express EGFRs (epidermal
growth factor receptors) and Lgr5 (leucine-rich repeat-containing G
protein-coupled receptor 5).

Merus had previously utilized the GlymaxX® Technology for its lead candidate,
MCLA-128, which is designed to bind to HER2 and HER3-expressing solid tumors.
Merus reported interim clinical data from an ongoing phase 1/2 clinical trial
for MCLA-128 in April 2016. These data included a favorable safety profile and
early signs of anti-tumor activity in patients with advanced solid tumors.

“We are pleased that Merus is again collaborating with ProBioGen for
development of their promising antibody cancer therapy, MCLA-158,” said Dr.
Wieland Wolf, CEO of ProBioGen. “Merus’ Biclonics® platform represents an
encouraging approach to the killing of cancer cells, and we believe that
Biclonics® utilizing our enhanced ADCC technology hold great promise in
potentially transforming the cancer treatment paradigm.”

“ProBioGen’s GlymaxX® technology is proven to increase an antibody’s ability to
bind to cellular targets, resulting in greater cell-killing proficiency,” said
Ton Logtenberg, PhD, Chief Executive Officer of Merus. “We are eager to advance
development of MCLA-158 utilizing this exciting technology, and we plan to file
an IND with the FDA by the end of next year. At the same time, we are
continuing to advance our other GlymaxX®-enabled candidate, MCLA-128 for
HER-expressing solid tumors, and we expect to report topline results from our
ongoing Phase 1/2 trial in the second half of 2017.”

ProBioGen’s GlymaxX® technology is based on the heterologous, cytosolic
expression of a bacterial enzyme that redirects the de-novo fucose synthesis
pathway towards a sugar-nucleotide that cannot be metabolized by the cell. The
enzyme mediates the secretion of antibodies with minimized fucose content. The
resulting modification of the glycostructure of IgG1 antibodies enhances their
binding to natural killer, or NK, cells and thus the ADCC response in potency
assays. Consequently, the potency of the modified antibodies, directed against
tumor or infected cells, is substantially increased.

About ADCC

ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity is an important
antibody function, leading to the selective killing of target cells, i.e.
cancerous cells or pathogen-infected cells. Several therapeutic antibody drugs
on the market rely on ADCC as a mechanism of action. ADCC enhancement has the
potential to increase the therapeutic effect and/or to greatly reduce antibody
dosage requirements, resulting in fewer side-effects and treatment costs.

About GlymaxX®

The GlymaxX® technology, developed by ProBioGen, prevents the synthesis of the
sugar “fucose” and hence, in antibody-producing cells, its addition to the
N-linked carbohydrate part of the antibody. The absence of fucose is known to
greatly enhance ADCC. The GlymaxX® technology is based on the stable
introduction of a gene for an enzyme which literally eliminates the producer
cells’ fucose biosynthesis pathway. As a unique feature, differentiating it
from other approaches, GlymaxX® can be applied to both novel and already
existing antibody producer cell lines and entire antibody expression and
discovery platforms, without negatively affecting their productivity or product
characteristics. Moreover, it is simple, rapid, potent, and universally
applicable to different Chinese hamster ovary, or CHO, hosts and all other
eukaryotic cell species. GlymaxX® can be rapidly applied in a few weeks to any
existing antibody producer cell line, can be used in the context of ProBioGen’s
pre-engineered GlymaxX® host cells, or can be introduced into entire animal
cell expression platforms by modifying the host cell line. ProBioGen offers its
GlymaxX® technology royalty-free as a service or as an individual license.

About ProBioGen

ProBioGen is a specialist for the development and manufacturing of complex
therapeutic glyco-proteins. Combining both state-of-the-art development
platforms together with intelligent product-specific technologies yields
biologics with optimized properties.

Rapid and integrated cell line and process development, comprehensive
analytical development and following reliable GMP manufacturing is performed by
a highly skilled and experienced team. All services and technologies are
embedded in a total quality management system to assure compliance with
international ISO and GMP standards (EMA/FDA).

ProBioGen is operational since more than 20 years and is located in Berlin,

About Merus N.V.

Merus is a fully-integrated biotechnology company developing cancer
therapeutics that combine the benefits of monoclonal antibodies with the
ability to simultaneously bind to multiple targets. Merus has two lead programs
in development: MCLA-128 for the treatment of solid tumors and MCLA-117 for the
treatment of acute myeloid leukemia. Merus is also developing a broad pipeline
of preclinical programs. Merus’ technologies encompass the proprietary MeMo®
transgenic mouse for the production of common light-chain human antibodies and
the CH3 heterodimerization technology for the production of full-length IgG
Biclonics®. These Biclonics® are robustly produced from a single clonal
manufacturing cell line, using industry-standard systems. Merus’ Biclonics® are
designed to bind to multiple disease-associated targets, thereby eliminating
tumor cells more efficiently and preventing tumor cells from escaping
treatment. In Merus’ Biclonics®-ENGAGE approach used in the MCLA-117 program,
bispecific antibodies are used to induce the cytotoxic activity of T-cells to
kill cancer cells.

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 impact our Biclonics® platform can have on cancer,
MCLA-158’s potential to treat colorectal cancer and other types of solid
tumors, the potential benefits ProBioGen’s GlymaxX® technology may have on our
Biclonics® pipeline, the timing of FDA filings and the timing and anticipated
results from our clinical trials.

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: we have incurred significant losses, are not currently profitable
and may never become profitable; our need for additional funding, which may not
be available and which may require us to restrict out operations or require us
to relinquish rights to our technologies or bispecific antibody candidates;
potential delays in regulatory approval, which would impact the ability to
commercialize our product candidates and affect our ability to generate
revenue; the unproven approach to therapeutic intervention of our Biclonics®
technology; potential difficulties in validating and developing companion
diagnostics, which could harm our development strategy; our limited operating
history; economic, political, regulatory and other risks involved with
international operations; exchange rate fluctuations or abandonment of the euro
currency; 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 adverse public reaction to
the use of cancer immunotherapies; potential delays in enrollment of patients,
which could affect the receipt of necessary regulatory approvals; our potential
exposure to costly and damaging liability claims; post-marketing restrictions
or withdrawal from the market; failure to obtain marketing approval
internationally; compliance with environmental, health, and safety laws and
regulations; anti-kickback, fraud, abuse, and other healthcare laws and
regulations exposing us to potential criminal sanctions; recently enacted or
future legislation; failure to compete successfully against other drug
companies; potential competition from other drug companies if we fail to obtain
orphan drug designation or maintain orphan drug exclusivity for our products;
the possibility that governmental authorities and health insurers may not
establish adequate reimbursement levels and pricing policies to support our
products; the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling, marketing and
distributing products and our lack of internal capability to do so; potential
competition from biosimilars; our reliance on third parties to conduct our
clinical trials and the potential for those third parties to not perform
satisfactorily; 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 being found invalid or unenforceable; potential lawsuits for
infringement of third-party intellectual property; adequate protection of our
trademarks; our potential failure to obtain extensions of the terms of patents
covering our products; potential difficulties protecting our intellectual
property rights in certain jurisdictions; changes in United States patent law;
protection of the confidentiality of our trade secrets; claims asserting that
we or our employees misappropriated a third-party’s intellectual property ...

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