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After the two monoclonal antibodies GT-MAB 2.5-GEX™ and CetuGEX™, the German biotech company Glycotope GmbH has recently received approvals to initiate clinical trials for its first glyco-optimised 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 pharmaco-kinetics of the product.
Based on GlycoExpress™, Glycotope’s development and production platform of glyco-engineered 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 glyco-optimisation of the molecule.
“After having two 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 glyco-optimised non-antibody product in the clinic, validating the broad applicability of GlycoExpress™ to not just antibodies but almost all glycosylated proteins,” said Dr Steffen Goletz, CEO, CSO and Founder of Glycotope. “In addition, we are expecting that the first patients for TrasGEX™, our glyco-optimised Trastuzumab, will be enrolled within the next weeks. We then will have successfully completed our ambitious plans to bring four glyco-optimised biopharmaceuticals into the clinic within a very short time”.