DGAP-News: Glycotope GmbH / Key word(s): Study
Glycotope GmbH: Glycotope medicates first patients in Phase IIb study
for novel glycooptimized anti-EGFR antibody CetuGEX(TM) to treat
squamous cell carcinomas of the head and neck (SCCHN)
02.04.2014 / 10:00
- CetuGEX(TM) demonstrates enhanced anti-tumor activities, reduced side
effects and a broader patient and indication range
Berlin, Germany, April 2, 2014 - Glycotope GmbH, one of the leading
companies in glycobiology, announced today the enrollment and treatment of
the first patients in its Phase IIb clinical trial of CetuGEX(TM).
CetuGEX(TM) is a novel anti-epidermal growth factor receptor (EGFR)
monoclonal antibody (mAb) with optimized and fully human glycosylation for
a greatly enhanced anti-tumor activity, reduced side effects and a
broadening of patient and indication range.
The 1:1 randomized Phase IIb study is designed to evaluate the efficacy and
safety of CetuGEX(TM) combined with chemotherapy compared to cetuximab plus
chemotherapy as a first line treatment of patients suffering from recurrent
and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). A
total of approximately 240 SCCHN patients are planned to be enrolled at
more than 40 sites in seven European countries and the USA.
In a single agent Phase I trial CetuGEX(TM) was well tolerated and showed
convincing therapeutic activity in treating patients with various solid
cancers who were progressive at inclusion. Furthermore, there were
noticeably lesser side effects (e.g. skin reactions) with CetuGEX(TM)
compared to other EGFR targeting molecules.
In this trial CetuGEX(TM) demonstrated a clinical benefit rate (CBR) of 82%
(22/28) of evaluable patients with several complete and partial responses
(objective response rate ORR = 18%) over all dose ranges (12 to 1370 mg).
Clinical benefit was often long lasting and occurred in patients where EGFR
therapy had previously failed and in several non-typical EGFR indications.
Longest benefit with >870 days is a complete response (CR) in a lung cancer
patient (still ongoing), and 80% of the responses lasted over 400 days.
CetuGEX(TM) was well tolerated with a low rate and low grade (only grade 1
or 2) of skin reactions (29% skin rash and 24% acneiform dermatitis,
partially overlapping) compared to other EGFR targeting molecules.
"The initiation of this Phase IIb trial is an important milestone for
Glycotope, not only in the clinical development of CetuGEX(TM) but also for
our comprehensive pipeline of immune enhanced anti-cancer antibodies," said
Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. "Already as single
agent in the Phase I clinical trial CetuGEX(TM) has achieved a larger
series of strong, long-lasting responses and clinical benefit in patients
with progressive solid cancers combined with lesser side effects,
especially in respect to typical skin reactions of EGFR therapies. These
results give us great confidence to enter into larger Phase IIb trials."
CetuGEX(TM), glycooptimized GT-MAB 5.2-GEX(TM), is a novel immune enhanced
anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) for
the treatment of non small cell lung cancer (NSCLC), metastatic colorectal
cancer (CRC), head and neck cancers as well as gastric and renal cancers
with optimized and fully human glycosylation. CetuGEX(TM) 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 in combination with a strong
single agent activity. These improvements aim for an expansion of the
number of suitable patients as well as indications.
Cetu-GEXTM is the second of Glycotope's antibodies in Phase IIb.
Glycotope specializes in the glycosylation of proteins and is one of
Germany's largest independent biotech companies. Glycotope has a broad
portfolio of drugs in clinical development, including the new cancer drugs,
PankoMab-GEX(TM) and CetuGEX(TM), both in Phase IIb trials, and
TrasGEX(TM), which has successfully completed its Ph I/IIa trial, as well
as its improved fertility hormone, FSH-GEX(TM), which is expected to begin
two Phase III clinical trials in 2014. In addition, the Company owns
various antibody and non-antibody biopharmaceutical candidates in
preclinical development. All products were glycooptimized, fully human
glycosylated and produced with exceptional quality, reproducibility and
yields using the validated GlycoExpress(TM) (GEX(TM)) technology. This
innovative technology enables Glycotope to increase the effectiveness,
tolerability and affordability of a large number of drugs and expands their
patient populations and indications.
Founded in 2001 on the Campus of the Max-DelbrÃ¼ck-Center for Molecular
Medicine in Berlin-Buch, Glycotope now has more than 180 employees at two
locations in Berlin and Heidelberg and covers the entire workflow from
discovery, molecule optimization, clone and process development,
preclinical and clinical drug development including GMP production. The
Company's investors include Munich-based Jossa Arznei GmbH (StrÃ¼ngmann
Group) and ELSA GmbH (Eckert Life Science Accelerator) in Berlin, which
have provided total financing in excess of EUR 130 million.
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
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