Glycotope Reported Promising 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 Reported Promising First-in-Man Data at ASCO 2013 for its
Glycooptimized anti-EGFR Antibody CetuGEX(TM) to Treat Solid Tumors
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Berlin, Germany, June 5th, 2013 - Glycotope GmbH, a global leader in optimizing
the sugar chains (glycosylation) of biopharmaceuticals, announced full details
of first-in-man Phase I trial data for CetuGEX(TM), an anti-epidermal growth
factor receptor (EGFR) monoclonal antibody (mAb) with optimized and fully human
glycosylation for a greatly enhanced anti-tumor activity and reduced side-
effects. The data was presented on Monday at ASCO 2013 in the Developmental
Therapeutics and Immunotherapy Session. 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 dosing regimen. Secondary endpoints included the preliminary evaluation of
anti-tumor activity of CetuGEX(TM). In conclusion, CetuGEX(TM) was well
tolerated with a favourable side-effect profile clearly lower than those
observed with other EGFR-targeting molecules and showed clear signs of
therapeutic activity as a single agent.
Activity was seen over all dose levels, with a clinical benefit rate of 76%
(19/25) in the per protocol population in this single agent study. All patients
were progressive upon inclusion into the study and heavily pre-treated with 78%
having received three or more prior chemotherapies. Four major clinical and
RECIST responses were observed besides long lasting disease stabilization,
including two complete and two partial responders in non-small cell lung cancer
(NSCLC), metastatic colorectal cancer, esophageal and gastric cancer. All
responders show continuing sustained responses and hence are still under
treatment, with the longest duration of over 18 months (Complete Responder stage
IV NSCLC). Additional 15 patients achieved sustained stable disease lasting from
eight weeks to over 14 months. CetuGEX(TM) showed a favourable side-effect
profile with few occurrence and low grades of EGFR-typical toxicities, including
acneiform skin rashes in 25% of patients and no skin reactions of grade 3 or
higher as well as <=10% low grades of digestion track toxicities. Infusion
reactions were restricted to the first infusions only and occurred in 57% with
the final dosing schedule. Pharmacokinetic data allow weekly or two-weekly
administration schedules. Clinical trial information: NCT01222637.
Prof. Dr. Walter Fiedler from University Hospital Hamburg-Eppendorf, who
presented the results of the study, concluded his presentation saying, that
CetuGEX(TM) showed high tolerability and clear signs of anti-cancer activity as
a single agent and should be further developed in Phase II. Steven R. Alberts,
M.D., from Mayo Clinic in Rochester, the discussant of the study, highlighted
the activity in heavily pretreated cancer patients and concluded that
CetuGEX(TM) results suggest a more tolerable EGFR antibody which he recommended
to develop further in clinic studies.
The full abstract can be found at: http://abstract.asco.org/index.html
About CetuGEX(TM)
Monoclonal antibody CetuGEX(TM), glycooptimized GT-MAB 5.2-GEX(TM), is a
BioSuperior EGFR antibody for 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. It expresses
several anti-tumor modes of action, a very strong antibody dependent cellular
toxicity (ADCC), 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 compared to
Cetuximab making it highly potent for patients of all ADCC receptor allotypes
and KRAS mutant patients. The molecule has an optimized bioavailability, lacks
foreign immunogenic carbohydrates and has shown a largely improved side-effect
profile compared to other EGFR antibodies such as low grade and low incidence of
skin rash. These improvements aim for an expansion of the number of suitable
patients as well as indications. Phase IIb clinical development is due to start
in Q3 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 has currently four products in clinical
development from late stage Phase I to late stage Phase II. 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 and 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/1707349/565355.pdf
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Source: Glycotope GmbH via Thomson Reuters ONE
[HUG#1707349]
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Datum: 05.06.2013 - 12:32 Uhr
Sprache: Deutsch
News-ID 266843
Anzahl Zeichen: 7580
contact information:
Town:
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