Glycotope to Report First-in-Man Data at ASCO 2013 for its Glycooptimized anti-EGFR Antibody CetuGEX(TM) to Treat Solid Tumors
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Glycotope GmbH /
Glycotope to Report First-in-Man Data at ASCO 2013 for its Glycooptimized
anti-EGFR Antibody CetuGEX(TM) to Treat Solid Tumors
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The issuer is solely responsible for the content of this announcement.
Berlin, Germany, May 31st, 2013 - Glycotope GmbH, a global leader in optimizing
the glycosylation of biopharmaceuticals, will report full details in its ASCO
2013 presentation on first-in-man Phase I trial data for CetuGEX(TM), an anti-
epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) with optimized
human glycosylation and manifold enhanced anti-tumor ADCC (antibody dependent
cellular cytotoxicity). In the Phase I trial 41 patients were treated with
various doses of CetuGEX(TM) to evaluate the safety and tolerability profile of
this novel compound and to define the recommended Phase II dose and regimen.
Secondary endpoints included the preliminary evaluation of anti-tumor activity
of CetuGEX(TM).
Presentation
+--------------+---------------------------------------------------------------+
|Abstract Title|CetuGEX(TM), an anti-epidermal growth factor receptor (EGFR) |
| |monoclonal antibody (mAb) with optimized human glycosylation |
| |and manifold enhanced anti-tumor ADCC: First-in-man Phase I |
| |trial data |
+--------------+---------------------------------------------------------------+
|Session Title |Developmental Therapeutics and Immunotherapy Session |
+--------------+---------------------------------------------------------------+
|Date and Time |Monday, June 3 at 5.30 pm |
+--------------+---------------------------------------------------------------+
|Location |Room 5406 |
+--------------+---------------------------------------------------------------+
About CetuGEX(TM)
Monoclonal antibody CetuGEX(TM), glycooptimized GT-MAB 5.2-GEX(TM), is a
BioSuperior EGFR-antibody for the treatment of NSCLC, metastatic colorectal
cancer (CRC), head and neck cancers as well as esophageal and gastric cancers.
CetuGEX(TM) is an anti-epidermal growth factor receptor (EGFR) monoclonal
antibody (mAb) with optimized and fully human glycosylation. The antibody
expresses several anti-tumor modes of action, has a very strong ADCC, plus
efficient proliferation inhibition via receptor blockage and apoptosis
induction. Based on the optimization of a series of sugar determinants
CetuGEX(TM) is 10 to 250-fold more active in anti-tumor ADCC when compared to
Cetuximab, making CetuGex(TM) highly potent for patients of all ADCC receptor
allotypes. Furthermore, the antibody has an optimized bioavailability, lacks
foreign immunogenic carbohydrates and has shown an improved skin reaction side
effect profile. These encouraging findings provide a strong basis for an
expansion of the number of suitable patients as well as indications. Phase IIb
clinical development is due to start in summer 2013.
About Glycotope
Glycotope, founded in 2001 in Berlin, focuses on the development of innovative
antibodies for the treatment of various cancer types. These GlycoBodies target
glycostructures on cell surfaces. In addition, Glycotope develops so-called
BioSuperiors, antibody and non-antibody recombinant biopharmaceuticals with
optimized and fully human sugar structures for clinical superiority. Key to the
glycooptimization technology is a toolbox of glycoengineered proprietary human
cell lines that allow the glycooptimization of proteins in respect to a whole
series of different determining sugars and is based on fully human
glycosylation. GlycoExpress allows the selection of the most appropriate and
best suitable human glycoform of a product and a high yield production superior
in reproducibility, quality and yield. Glycooptimization via GlycoExpress
provides improved efficacy, bioavailability, immunogenicity and broadens the
potential patient populations and indications, as well as providing a much
improved cost-effectiveness. Glycotope currently has four products in clinical
development. The Company's additional pipeline includes preclinical non-antibody
and antibody biopharmaceuticals for various indications.
Together with Glycotope-Biotechnology in Heidelberg, Glycotope has evolved into
a leading fully integrated glycobiology company, covering all phases discovery,
preclinical and clinical drug development as well as GMP production. With more
than 150 employees and a strong and broad IP-platform, Glycotope has grown to
one of the largest biotechnology companies in Germany.
Contact:
Glycotope GmbH
Dr. Franzpeter Bracht, CFO & CBO
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(at)glycotope.com
Website: www.glycotope.com
Press Release PDF:
http://hugin.info/157017/R/1706313/564728.pdf
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Source: Glycotope GmbH via Thomson Reuters ONE
[HUG#1706313]
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Datum: 31.05.2013 - 13:52 Uhr
Sprache: Deutsch
News-ID 265252
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