After the two monoclonal antibodies GT-MAB 2.5-GEX™ and CetuGEX™, the German biotech company Glycotope has recently received approvals to initiate clinical trials for its first glycooptimized non-antibody protein therapeutic FSH-GEX™. FSH-GEX™ is a follicle-stimulating hormone which will be developed for in vitro fertilisation and the treatment of anovulatory infertility. It is produced recombinantly with a fully human glycosylation. In April Glycotope has enrolled the first subjects into a phase I clinical trial in the Netherlands to evaluate the safety, tolerability, dosing requirements and pharmacokinetics of the product.
Based on GlycoExpress™, Glycotope´s development and production platform of glycoengineered human cell lines, FSH-GEX™ combines into one single product the safety advantages of a recombinant origin with the fully human nature of pharmaceuticals derived from urinary sources plus the glycooptimization of the molecule.
“After having 2 antibodies in clinical trials and a third antibody approved by the competent authority, starting the clinical phase for FSH-GEX™ is an important milestone for the company, as it is our first glycooptimized non-antibody product in the clinic, validating the broad applicability of GlycoExpress™ to not just antibodies but almost all glycosylated proteins”, states Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. “In addition, we are expecting that the first patients for TrasGEX™, our glycooptimized Trastuzumab, will be enrolled within the next weeks. We then will have successfully completed our ambitious plans to bring four glycooptimized biopharmaceuticals into the clinic within a very short time”.
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 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 organisations in Germany.