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3 Aug 2015
Glycotope’s GlycoExpress™ glyco-optimization platform reaches clinically validated superior quality and unmet production yields of ADCC-improved antibodies
  • GlycoExpress™ allows to combine optimization of several carbohydrate features for maximization of ADCC activity of antibodies
  • Superior yields of 10-20 g/L bioreactor volume with up to 0.8 g/L per day reached regularly as demonstrated with three antibodies in advanced clinical development
  • GlycoExpress™ showed outstanding reproducibility in 40 GMP production runs without measurable differences

Glycotope GmbH, a global leader in glyco-optimization of biopharmaceuticals, today updates on its proprietary GlycoExpress™ (GEX™) platform for superior quality as well as superior yield for low production costs of ADCC-(antibody-dependent cell-mediated cytotoxicity)-improved monoclonal antibodies.

Glycotope’s GEX™ platform comprises a comprehensive portfolio of proprietary glycoengineered human suspension cell lines, which allow for the production of proteins with tailored glycosylation patterns. With the combined advantages of optimized sialylation, galactosylation, fucosylation, branching and lack of non-human sugar structures, GEX™ products deliver
improved bioactivity, stability, serum half-life and immunogenicity of biopharmaceuticals.

GEX™ today is the only platform that provides the opportunity to combine several features to maximize ADCC activity of fully human glyco-optimized monoclonal antibodies. By combination of minimizing fucosylation, maximizing galactosylation and branching, the ADCC activity can be maximally increased. This together with the unmet production yields and the superior reproducibility makes Glycotope’s GEX™ the most potent platform for ADCC improvement.

GlycoExpress™ – a clinically validated platform for glyco-optimized fully human
biopharmaceuticals

CetuGEX™ and TrasGEX™, two best-in-class molecules targeting EGFR and Her2, respectively, were tested in Phase I/IIa clinical trials with patients who failed standard therapies. Strong clinical benefit and responses were observed in patients in whom therapies with nonglyco- optimized antibodies had already failed. Clinical benefit was observed in both, typical and non-typical indications of the non-glyco-optimized antibodies. All these observations clearly demonstrate the advantages of glyco-optimization for cancer therapies when using the GlycoExpress™ technology.

GlycoExpress™ provides regular production levels of 10-20 g/L bioreactor volume and up
to 0.8 g/L per day and outstanding reproducibility in 40 GMP production runs

Glycotope has demonstrated with three different antibodies in advanced stage clinical development that cost efficient production with unmet quality is achieved through a proprietary perfusion process with outstanding productivity of 10-20 g/L bioreactor volume and up to 0.8 g/L per day. To date, more than 40 GMP production runs have been performed, showing unique reproducibility with no measurable differences between batches, batch sizes, process strategies, scales and production sites, all of which guarantees flexible production. The GEX™ platform is approved by several regulatory authorities for clinical use (including EMA, FDA).

About Glycotope

Glycotope, founded in 2001 in Berlin, focuses on the development of innovative immuneoncological products for the treatment of various cancer types using their GlycoBody™ and GlycoExpress™ technologies. Glycotope has currently four products in advanced clinical development. The Company’s additional pipeline includes preclinical non-antibody and antibody biopharmaceuticals for various indications.

Glycotope´s GEX™ platform allows glyco-optimization and high yield production of a variety of fully human glycosylated biopharmaceuticals such as coagulation factors, cytokines, glycoprotein hormones and antibodies by using a toolbox of glyco-engineered proprietary human cell lines that allow for optimization of a whole series of different determining sugars. In addition, the GEX™ platform can be used for in process glycosylation control.

The platform allows for the development of First-in-Class antibodies addressing targets previously unattainable, as well as optimized and significantly improved molecules in terms of clinical effects and reduced side effect profile (Best-in-Class).

Together with its GMP manufacturing 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 200 employees and a strong and broad IP-position, Glycotope today is one of the largest biotechnology companies in Germany. Glycotope has created the currently broadest and most potent glycosylation technology platform.

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