Glycotope GmbH, a leading company in the field of glycomics, announced today the enrollment of the first patients in a phase I dose finding trial to evaluate safety and tolerability of TrasGEX™. TrasGEX™ is a biobetter of the marketed Trastuzumab / Herceptin™ targeting the HER2-receptor, commonly overexpressed in a variety of cancers. TrasGEX™ has been glycooptimized to yield a manifold higher anti-tumor activity and is supposed to be suitable for the treatment of an enlarged patient spectrum. It was developed using GlycoExpress™, the company’s development and production platform based on glycoengineered human cell lines for biopharmaceuticals with fully human and optimized glycosylation.
“We are delighted to see our 4th glycooptimized biopharmaceutical product in clinical trials”, says Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. “After CetuGEX™ and PankoMab-GEX™, TrasGEX is our 3rd anti-cancer antibody which entered clinical trials in time. GlycoExpress has been proven to be the broadest glycooptimization technology not only for antibodies but also for most other glycoproteins. Our glycooptimized Follicle-Stimulating Hormone FSH-GEX™ has already completed clinical phase Ia with very exciting results. Currently we are advancing a broad range of pre-clinical products in various therapeutic areas”.
GLYCOTOPE, founded in 2001 in Berlin, focuses on the optimization and humanization of therapeutically relevant sugar structures on biopharmaceuticals known as glycosylation and on the development of innovative antibodies targeting glycostructures on cell surfaces. Biologics developed in Glycotope´s GlycoExpress™ technology of glycoengineered human cell lines receive a fully human and optimized glycosylation, leading to a largely improved activity, an elongated half-life time and/or reduced immunogenicity and hence important therapeutic benefits for a significantly increased number of patients. In addition, the GlycoExpress platform is superior in productions yields, product quality and reproducibility compared to other production platforms.
Glycotope´s product portfolio now encompasses a variety of antibodies and non-antibody biologics, 4 of which are currently in the clinical stage. This 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 already marketed therapeutic proteins, so called Biobetters.
Together with Glycotope-Biotechnology in Heidelberg, Glycotope evolved into a leading integrated glycobiology company, covering all phases in drug development such as lead discovery and optimization, preclinical and process development, GMP production and clinical development. With more than 140 employees, the group has grown to one of the largest Biotech organizations in Germany.