Glycotope Received Regulatory Approval for Glycooptimized and Fully Human Glycosylated Antibody CetuGEX™ and Enrolls First Patients in Clinical Trial

Berlin, Germany – August 4, 2010

Glycotope GmbH, a leading glycobiology company, has received regulatory approval by German and Italian regulatory authorities for a Phase I study of Glycotope´s next generation antibody CetuGEX™ (GT-MAB 5.2-GEX) for the treatment of various solid cancers. “For Glycotope, the approval of CetuGEX™, our second antibody in the clinic, represents another important milestone,” says Steffen Goletz, CEO & CSO of Glycotope. “CetuGEX™ is our first in a series of next generation biotherapeutic products. We expect that the strong advantages in various product aspects we have seen in preclinical studies will manifest in a clear clinical superiority compared to the currently marketed product. In addition, the second cell line of Glycotope´s glycooptimization platform GlycoExpress™ based on human cell lines has now been approved, meeting our ambitions for quality and speed.” CetuGEX™ was the second antibody in clinical stage produced in Glycotope´s own GMP facility in Heidelberg.

About CetuGEX™

CetuGEX™ is an improved version of a currently marketed anti-EGFR antibody which has been approved for the treatment of colorectal and head & neck cancers. The antibody’s fully human glycosylation is optimized to yield a largely improved anti-tumor ADCC activity, bioavailability and contains no non-human immunogenic carbohydrate structures and facilitates treatment of a highly increased number of patients. This was achieved with Glycotope´s proprietary technology platform GlycoExpress™, a screening and high yield production system of glycoengineered human cell lines.

About Glycotope GmbH

GLYCOTOPE, founded in 2001, focuses on the optimization and humanization of therapeutically relevant carbohydrate structures known as glycosylation and on the development of innovative antibodies targeting glycostructures on cell surfaces. GlycoExpress™, one of the company’s proprietary technologies, allows making existing and new biopharmaceutical drugs more effective and tolerable in the human body, which is of considerable medical as well as economic importance. Glycotope evolved into a leading integrated glycobiology company, covering all steps from lead discovery, preclinical development, GMP production and clinical development. Glycotope´s most advanced pipeline includes antibodies against novel targets for cancer therapy (e.g. GT-MAB 2.5-GEX™) and significantly improved versions of antibodies as well as other marketed therapeutic proteins.

Contact:

Glycotope GmbH
Dr. Franzpeter Bracht
Robert-Roessle-Str. 10
13125 BERLIN
Germany

Tel.: +49-30-9489-2600
Fax: +49-30-9489-2609
Web: www.glycotope.com
eMail: news@glycotope.com


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GLYCOTOPE moves to new premises

Berlin, December 10th, 2009 – Following it’s outstanding growth in the past 18 months, raising the headcount from 20 to 70 employees, GLYCOTOPE has now consolidated it’s dispersed teams and expanded it’s office and laboratory space in a new location on the Biotech Campus Berlin Buch.

Instead of in the complexes D79 and D80, GLYCOTOPE now resides within the 1st and 2nd floor of “Arnold-Graffi-Haus” D85 .

Our contact details remain unchanged:

GLYCOTOPE GmbH
Robert-Roessle-Str. 10
13125 BERLIN
Germany

Tel.: +49-30-9489-2600
Fax: +49-30-9489-2609
Web: www.glycotope.com
eMail: info@glycotope.com

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GLYCOTOPE receives regulatory approval for GlycoExpress Technology and initiates first clinical trial with lead antibody GT-MAB 2.5 GEX

Berlin – November 23rd, 2009

Glycotope GmbH, a leading German Biotech company, has received regulatory approval by Germany and Italian regulatory authorities for a Phase I study of Glycotope´s lead antibody GT-MAB 2.5-GEXTM for the treatment of various solid cancers. The approvals further underline the suitability of Glycotope´s proprietary GlycoExpressTM technology for the improvement, glycooptimization and high yield production of therapeutic proteins for the use in humans.

“The approval of GT-MAB 2.5-GEX as well as the regulatory approval of the GlycoExpress production technology based on its glycoengineered human cell lines represents a significant milestone for the company” says Steffen Goletz, PhD, Founder, CEO and CSO of Glycotope. “After generating very encouraging data in pre-clinical studies, we are now looking forward to demonstrate the importance of glycosylation in the clinic by generating a substantial benefit to patients.”

The Phase I study will evaluate the safety and tolerability of GT-MAB 2.5-GEXTM in a broad series of cancer indications.

About GT-MAB 2.5-GEX

GT-MAB 2.5-GEXTM is a novel, exceptionally potent monoclonal antibody for the treatment of a broad variety of cancer indications. The antibody is directed against a novel tumor-specific combined carbohydrate-protein epitope present in a large number of patients of various cancers. GT-MAB 2.5-GEXTM shows three highly effective key modes of anti-tumor action: ADCC, phagocytosis and induction of apoptosis with an exceptionally high and specific tumor accumulation and tumor killing already at doses as low as 0.5 mg/kg.

The antibody’s fully human glycosylation is optimized to yield a largely improved ADCC activity, bioavailability and no non-human immunogenic carbohydrate structures. This was achieved by Glycotope´s proprietary technology platform GlycoExpressTM, a screening and high yield production system of glycoengineered human cell-lines that allows significant enhancement of therapeutic potency by optimizing a protein’s glycosylation in various aspects.

About Glycotope GmbH

GLYCOTOPE was founded in 2001 and focuses on the improvement and humanization of glycosylation structures on proteins, a comparatively new field in biotechnology. GlycoExpressTM, the company’s proprietary technology permits making existing and new drugs more effective and tolerable in the human body, which is of considerable medical as well as economic importance. The current product range currently includes both proprietary antibodies for cancer therapy (e.g. GT-MAB 2.5-GEXTM) and significantly improved versions (2nd generation) of antibodies and other therapeutic proteins already on the market.

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GLYCOTOPE-BIOTECHNOLOGY launches CMV-Tetramer kit

Heidelberg, 24 July 2009 – Progressive CMV infections pose a major threat to transplant recipients. CD8 T cells are considered as the major player to control CMV viremia and sufficient levels of CMV-specific CD8 T cells are found to protect against CMV disease.

Current assays based on PCR and antigen-detection are capable of analysing the viral burden and detect a CMV reactivation, however, any immunoreactivtity against CMV cannot be assessed.

Glyctope Biotechnology has developed a ready-to-use CMV-Tetramer Test that provides for the first time a possibility to quantify the number of CMV-specific CD8 T cells, thus helping the clinician to assess patients with high risk to develop CMV disease.

Main assay features:

  • Standardized and CE-certified ready-to-use staining kit (performance time about 2h)
  • Direct analysis of whole blood
  • Highly specific and sensitive detection of CMV-specific CD8 T cells due to the use of tetramers
  • Combination of well characterized CMV peptides that cover about 80% of HLA types
  • Determination of the absolute numbers of CMV-specific CD8 T cells and the percentage CD4 and CD8 T cells.

Economic Benefits:

  • Kit contains all necessary compounds including a negative control
  • Easy and economic procedure based on flow cytometry achieving quick results at low costs with high accuracy and precision

Expected benefits of monitoring the CMV-specific CD8 T cell number:

  • The Test allows the clinician to assess the immune status of the patient to combat with the progressive viral infection.
  • It helps the clinician to reduce the amount of toxic and expensive antiviral drugs in the treatment

References:
1) Gratama & Cornelissen, Clin. Appl. Immun.Rev. 2001
2) Moss & Khan, Hum. Immun. 2004
3) Cwynarski et al. Blood 2001
4) Gratama et al. Blood 2001
5) Gratama et al., Cytometry B Clin. Cytom. 2008

For further information, please visit the CMV-Tetramer section on the website of Glycotope Biotechnology.

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Glycotope Service Portfolio expanded with aseptic Fill & Finish

Heidelberg, 05 June 2009 – GLYCOTOPE BIOTECHNOLOGY, an established
CMO equipped with state-of-the-art technologies and more than 25 years of
experiences in GMP production of biotherapeutics announces the approval for Fill
Finish of clinical grade material. Since then, the company has successfully completed
five Fill & Finish projects for different customers.
The approval allows GLYCOTOPE BIOTECHNOLOGY to provide its customers with
a complete service “from the gene to the drug” at highest technological level. As a
unique benefit, we offer our clients the use of our toolbox of human, glycoengineered
cell lines (GlycoExpress™) for glycooptimization of biopharmaceuticals. Our knowhow
in controlling glycosylation patterns of antibodies and other therapeutic proteins
during cell line development and establishment of production processes is of pivotal
importance not only in the development of glycooptimized biotherapeutics but also of
biosimilars that need to have the same characteristics as the originator product.

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