DGAP-News: Glycotope GmbH: Glycotope's GlycoExpress(TM) glyco-optimization platform reaches clinically validated superior quality and unmet production yields of ADCC-improved antibodies


DGAP-News: Glycotope GmbH / Key word(s): Miscellaneous
Glycotope GmbH: Glycotope's GlycoExpress(TM) glyco-optimization
platform reaches clinically validated superior quality and unmet
production yields of ADCC-improved antibodies

03.08.2015 / 12:00

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Glycotope's GlycoExpress(TM) glyco-optimization platform reaches clinically
validated superior quality and unmet production yields of ADCC-improved
antibodies

  - GlycoExpress(TM) allows to combine optimization of several carbohydrate
    features for maximization of ADCC activity of antibodies

  - Superior yields of 10-20 g/L bioreactor volume with up to 0.8 g/L per
    day reached regularly as demonstrated with three antibodies in advanced
    clinical development

  - GlycoExpress(TM) showed outstanding reproducibility in 40 GMP
    production runs without measurable differences

Berlin, Germany, August 3rd, 2015 - Glycotope GmbH, a global leader in
glyco-optimization of biopharmaceuticals, today updates on its proprietary
GlycoExpress(TM) (GEX(TM)) platform for superior quality as well as
superior yield for low production costs of ADCC-(antibody-dependent
cell-mediated cytotoxicity)-improved monoclonal antibodies.

Glycotope's GEX(TM) platform comprises a comprehensive portfolio of
proprietary glyco-engineered human suspension cell lines, which allow for
the production of proteins with tailored glycosylation patterns. With the
combined advantages of optimized sialylation, galactosylation,
fucosylation, branching and lack of non-human sugar structures, GEX(TM)
products deliver improved bioactivity, stability, serum half-life and
immunogenicity of biopharmaceuticals.

GEX(TM) today is the only platform that provides the opportunity to combine
several features to maximize ADCC activity of fully human glyco-optimized
monoclonal antibodies. By combination of minimizing fucosylation,
maximizing galactosylation and branching, the ADCC activity can be
maximally increased. This together with the unmet production yields and the
superior reproducibility makes Glycotope's GEX(TM) the most potent platform
for ADCC improvement.

GlycoExpress(TM) - a clinically validated platform for glyco-optimized
fully human biopharmaceuticals

CetuGEX(TM) and TrasGEX(TM), two best-in-class molecules targeting EGFR and
Her2, respectively, were tested in Phase I/IIa clinical trials with
patients who failed standard therapies. Strong clinical benefit and
responses were observed in patients in whom therapies with
non-glyco-optimized antibodies had already failed. Clinical benefit was
observed in both, typical and non-typical indications of the
non-glyco-optimized antibodies. All these observations clearly demonstrate
the advantages of glyco-optimization for cancer therapies when using the
GlycoExpress(TM) technology.

GlycoExpress(TM) provides regular production levels of 10-20 g/L bioreactor
volume and up to 0.8 g/L per day and outstanding reproducibility in 40 GMP
production runs

Glycotope has demonstrated with three different antibodies in advanced
stage clinical development that cost efficient production with unmet
quality is achieved through a proprietary perfusion process with
outstanding productivity of 10-20 g/L bioreactor volume and up to 0.8 g/L
per day. To date, more than 40 GMP production runs have been performed,
showing unique reproducibility with no measurable differences between
batches, batch sizes, process strategies, scales and production sites, all
of which guarantees flexible production.

The GEX(TM) platform is approved by several regulatory authorities for
clinical use (including EMA, FDA).

About Glycotope

Glycotope, founded in 2001 in Berlin, focuses on the development of
innovative immune-oncological products for the treatment of various cancer
types using their GlycoBody(TM) and GlycoExpress(TM) technologies.
Glycotope has currently four products in advanced clinical development. The
Company's additional pipeline includes preclinical non-antibody and
antibody biopharmaceuticals for various indications.

Glycotope's GEX(TM) platform allows glyco-optimization and high yield
production of a variety of fully human glycosylated biopharmaceuticals such
as coagulation factors, cytokines, glycoprotein hormones and antibodies by
using a toolbox of glyco-engineered proprietary human cell lines that allow
for optimization of a whole series of different determining sugars. In
addition, the GEX(TM) platform can be used for in process glycosylation
control.

The platform allows for the development of First-in-Class antibodies
addressing targets previously unattainable, as well as optimized and
significantly improved molecules in terms of clinical effects and reduced
side effect profile (Best-in-Class).

Together with its GMP manufacturing subsidiary Glycotope Biotechnology in
Heidelberg, Glycotope has evolved into a leading fully integrated
glycobiology company, covering the entire workflow from discovery, molecule
optimization, clone and process development, preclinical and clinical drug
development to GMP production. With more than 200 employees and a strong
and broad IP-position, Glycotope today is one of the largest biotechnology
companies in Germany. Glycotope has created the currently broadest and most
potent glycosylation technology platform.

Contact:

GLYCOTOPE GmbH
Dr. Franzpeter Bracht, COO
Robert-Roessle-Str. 10
D-13125 Berlin, Germany

Phone: +49-(0)30 94 89-2600
Fax: +49-(0)30 94 89-2609
Email: franzpeter.bracht@glycotope.com

Website: www.glycotope.com



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