Glycotope's GlycoExpress Glyco-Optimization Platform Reaches Clinically Validated Superior Quality and Unmet Production Yields of ADCC-Improved Antibodies

Glycotope 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 GEXplatform comprises a comprehensive portfolio of proprietary glyco-engineered 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.

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 non-glyco-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.

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).