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

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

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-GEX^TM for the treatment of various solid cancers. The approvals further underline the suitability of Glycotope´s proprietary GlycoExpress^TM 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-GEX^TM in a broad series of cancer indications.

About GT-MAB 2.5-GEX

GT-MAB 2.5-GEX^TM 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-GEX^TM 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 GlycoExpress^TM, 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. GlycoExpress^TM, 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-GEX^TM) and significantly improved versions (2nd generation) of antibodies and other therapeutic proteins already on the market.

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.

“With the acquisition of the production capacities in four separate GMP suites, we are creating excellent basic conditions for the further development of our glycosylation technology, with which we are improving both our own and other products already on the market,” explains Steffen Goletz, founder and scientific head of the company. In addition, GLYCOTOPE now operates independently in the GMP-based production of its development candidates. The company already has its first manufacturing licenses under the Medicines Act (AMG).

“We see this as an important step in optimising the value creation chain for the
strategic positioning of our associate company,” says Helmut Jeggle, representative of Athos GmbH. The purchase was financed and co-initiated through another capital increase signed by investor Jossa Arznei GmbH. Behind Jossa stands Athos GmbH which, as the family office of the Strüngmann brothers, now makes its know-how available to select biotech companies and embarks

“In order to further expand the capital-intensive, pioneeringbiotechnology position at the Heidelberg production site with the glycoprotein know-how developed at ORPEGEN, the transfer of biopharmaceutical assets to the financially stronger GLYCOTOPE was the logical, appropriate thing to do,” says Christian Birr, managing partner of ORPEGEN Pharma, which he founded in 1982. The development and production of peptide agents, amino acid derivatives and small molecules will be independently continued by the former Chemistry division at the site, while co- shareholder Hightech Beteiligungen GmbH & Co. KG will withdraw from its involvement in ORPEGEN Pharma.

About Glycotope GmbH
The product range of GLYCOTOPE GmbH covers various antibodies and other biopharmaceuticals. This includes both its own antibodies for tumour therapy (PankoMab, KaroMab) and much improved versions (2^nd generation) of antibodies already available on the market or other proteins used in therapy.

The innovative character of GLYCOTOPE’s basic technology “GlycoExpress™”, which is based on glyco-optimised human high-production cell lines, lies in the development of new drug compounds as well as in the humanisation and optimisation of glycosylation structures and hence the associated enormousincrease in the effectiveness of so-called “2^nd generation” agents.

GLYCOTOPE was founded in 2001 by the biologist and biochemist Dr. Steffen Goletz and seed phase investor Eckert Consult Strategieberatung und Kapitalbeteiligungsgesellschaft mbH. The company operates on glycosylation structures on proteins, a relatively young sector in biotechnology. Its proprietary technology for optimization of glycosylation structures on proteins and biopharmaceuticals production permits making existing and new drugs more effective and tolerable in the human body, which is of considerable economic importance for new as well as improved versions of protein-based drugs (2^nd generation biopharmaceuticals).

The GLYCOTOPE GmbH product range features a number of antibodies and other proteins. They include both proprietary antibodies for tumour therapy (PankoMab, KaroMab) and significantly improved versions (2nd generation) of antibodies and other therapeutic proteins already on the market. The innovative company’s base technology supports the development of new active substances and marked improvement of the glycosylation structures and optimization of their effectiveness.

„The fresh capital helps us improve our financial resources dramatically, while also bringing us a strong and experienced partner. This will enable us to accelerate the development of our projects considerably and expand our glycosylation technology platform,“ said the management team comprising Dr. Steffen Goletz, Dr. Franzpeter Bracht and Dr. Hans Baumeister.