Glycotope Doses First Patients in Phase IIb Study with PankoMab-GEX(TM) for the Maintenance Therapy of Ovarian Carcinoma
(Thomson Reuters ONE) -
Glycotope GmbH /
Glycotope Doses First Patients in Phase IIb Study with PankoMab-GEX(TM) for the
Maintenance Therapy of Ovarian Carcinoma
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* First therapeutic glycooptimized antibody against a novel tumor-specific
carbohydrate-protein mixed epitope on a series of cancer cells
* Excellent tolerability, no significant toxicity and strong anti-tumor
activity observed as single agent in a Phase I trial
Berlin, Germany, November 25th, 2013 - Glycotope GmbH, a global leader in
developing therapeutic antibodies targeting glycosylated epitopes on cancer
cells and optimizing the glycosylation of biopharmaceuticals, today announced
the enrollment and treatment of first patients in its Phase IIb clinical trial
of PankoMab-GEX(TM) for maintenance therapy of patients with ovarian cancer.
PankoMab-GEX(TM) is the first fully human glycosylated and glycooptimized
antibody against a novel tumor-specific carbohydrate-protein mixed epitope (TA-
MUC1) abundantly present on a larger set of tumor indications, metastasis and
cancer stem cells, and virtually absent on normal cells.
The double-blind, randomized, placebo-controlled Phase IIb study is designed to
evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX(TM). A
total of approximately 210 patients suffering from recurrent ovarian carcinoma
and at least stable under current chemotherapy are planned to be enrolled at 41
sites in seven European countries and Russia.
The primary endpoint of the Phase IIb trial is progression free survival.
Secondary endpoints include further efficacy data such as time to progression,
objective response rate, clinical benefit rate and overall survival as well as
pharmacokinetic and safety data.
PankoMab-GEX(TM) showed excellent tolerability, no significant toxicity and
strong anti-tumor activity in a single agent Phase I trial in patients with
progressive disease and with various indications including ovarian and lung
carcinoma. Patients with progressive ovarian cancer which were resistant or
sensitive to their most recent platinum containing therapy and with no further
treatment option showed in 80% of the cases clinical benefit with an average
duration of more than 210 days.
"The initiation of this Phase IIb trial is an important milestone for Glycotope,
not only in the clinical development of PankoMab-GEX(TM) but also for our
comprehensive pipeline of cancer specific GlycoBodies," said Dr. Steffen Goletz,
CEO, CSO and Founder of Glycotope. "The results PankoMab-GEX(TM) achieved
already as single agent in a clinical Phase I trial in patients progressive at
treatment start are very encouraging with significant tumor reduction, complete
and partial responses with long lasting disease stabilization of up to 25 months
and the virtual lack of relevant toxicities."
About PankoMab-GEX(TM)
PankoMab-GEX(TM) is a potent humanized and glycooptimized therapeutic antibody
(IgG1) recognizing Glycotope's novel carbohydrate-induced conformational TA-MUC1
epitope expressed on the majority of tumor cells in a wide variety of cancers.
The epitope comprises a tumor-specific carbohydrate antigen together with the
immunodominant peptide region of MUC1, combining high tumor-specificity, high
number of binding sites and affinity. It is abundantly present on primary
tumors, metastasis and cancer stem cells and virtually absent on normal cells.
Main target indications include ovarian, lung, breast and gastrointestinal
tumors, and other, mostly with over 90% of the patients and tumor cells.
PankoMab-GEX(TM) expresses a series of potent anti-tumor modes of action,
including antibody-dependent cellular cytotoxicity (ADCC), tumor cell
phagocytosis and apoptosis induction, strongly enhanced by glycooptimization
through Glycotope's GlycoExpress(TM) platform. This allows a significantly
improved treatment outcome compared to non-glycooptimized biotherapeutics.
PankoMab-GEX(TM) is the lead molecule of Glycotopes's GlycoBody technology which
represents the Company's treasure box of more than 200 monoclonal antibodies.
About Glycotope
Glycotope, founded 2001 in Berlin, focuses on the development of innovative
antibodies for the treatment of various cancer types. These GlycoBodies(TM)
target glycostructures or carbohydrate-peptide mixed epitopes 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(TM )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(TM) 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 its 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 160 employees and a
strong and broad IP-platform, Glycotope today is 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/1745418/587431.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Glycotope GmbH via GlobeNewswire
[HUG#1745418]
Unternehmensinformation / Kurzprofil:
Datum: 25.11.2013 - 09:24 Uhr
Sprache: Deutsch
News-ID 319832
Anzahl Zeichen: 7434
contact information:
Town:
Berlin
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 159 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Glycotope Doses First Patients in Phase IIb Study with PankoMab-GEX(TM) for the Maintenance Therapy of Ovarian Carcinoma"
steht unter der journalistisch-redaktionellen Verantwortung von
Glycotope GmbH (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
