Glycotope Received Regulatory Approval for Glycooptimized and Fully Human Glycosylated Antibody CetuGEX(TM) and Enrolls First Patients in Clinical Trial

Glycotope GmbH, a leading glycobiology company, has received regulatory approval by German and Italian regulatory authorities for a Phase I study of Glycotope's next generation antibody CetuGEX(TM) (GT-MAB 5.2-GEX) for the treatment of various solid cancers.

"For Glycotope, the approval of CetuGEX(TM) , our second antibody in the clinic, represents another important milestone," says Steffen Goletz, CEO & CSO of Glycotope. "CetuGEX(TM) is our first in a series of next generation biotherapeutic products. We expect that the strong advantages in various product aspects we have seen in preclinical studies will manifest in a clear clinical superiority compared to the currently marketed product. In addition, the second cell line of Glycotope's glycooptimization platform GlycoExpress(TM) based on human cell lines has now been approved, meeting our ambitions for quality and speed." CetuGEX(TM) was the second antibody in clinical stage produced in Glycotope's own GMP facility in Heidelberg.

About CetuGEX(TM)

CetuGEX(TM) is an improved version of a currently marketed anti-EGFR antibody which has been approved for the treatment of colorectal and head & neck cancers. The antibody's fully human glycosylation is optimized to yield a largely improved antitumor ADCC activity, bioavailability and contains no nonhuman immunogenic carbohydrate structures and facilitates treatment of a highly increased number of patients. This was achieved with Glycotope's proprietary technology platform GlycoExpress(TM) , a screening and high yield production system of glycoengineered human cell lines.