Merus N.V. Signs Commercial Multi-Product License for ProBioGen's GlymaxX® ADCC Enhancement Technology
(Thomson Reuters ONE) -
Bispecific Cancer Antibody Pipeline Optimized by GlymaxX® Manufacturing
Technology
BERLIN & UTRECHT, The Netherlands, June 01, 2016 (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(®) www.glymaxx.com
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 www.probiogen.de
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,
Germany.
About Merus N.V. www.merus.nl
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 or otherwise claiming ownership of what we regard as our intellectual
property; compliance with patent regulations; potential system failures; our
ability to attract and retain key personnel; managing our growth could result in
difficulties; the price of our common stock may fluctuate substantially; certain
of our shareholders and members of our management board own a majority of our
outstanding shares and exercise significant control over us; a significant
portion of our total outstanding shares are eligible to be sold into the market;
provisions of our Articles of Association or Dutch corporate law might deter
favorable acquisition bids for us or prevent a beneficial change of control; we
may lose our foreign private issuer status and incur significant expenses as a
result; and unfavorable or lacking analyst research or reports might cause the
price of our common shares to decline.
These and other important factors discussed under the caption "Risk Factors" in
our final prospectus filed with the Securities and Exchange Commission, or SEC,
on May 20, 2016 relating to our Registration Statement on Form F-1, 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. 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.
Contact ProBioGen AG:
Dr. Gabriele Schneider
Vice President Business Development
ProBioGen AG
13086 Berlin, Germany
Phone: +49 30 924 006-0
E-mail: glymaxx(at)probiogen.de
Website: www.glymaxx.de
Contact Merus B.V.:
S. Margetson
E-mail: s.margetson(at)merus.nl
Padualaan 8
3584CH Utrecht, The Netherlands
Media Inquiries for Merus:
akampion
Dr. Ludger Wess or Ines-Regina Buth
Phone: +49 40 88 16 59 64 / +49 30 2363 2768
E-mail: info(at)akampion.com
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Merus N.V. via GlobeNewswire
[HUG#2017156]
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Datum: 01.06.2016 - 13:45 Uhr
Sprache: Deutsch
News-ID 475030
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"Merus N.V. Signs Commercial Multi-Product License for ProBioGen's GlymaxX® ADCC Enhancement Technology"
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