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Glycotope Received Regulatory Approval for Glycooptimized and Fully Human Glycosylated Antibody CetuGEX™ 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™ (GT-MAB 5.2-GEX) for the treatment of various solid cancers.

“For Glycotope, the approval of CetuGEX™, our second antibody in the clinic, represents another important milestone,” says Steffen Goletz, CEO & CSO of Glycotope. “CetuGEX™ 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™ based on human cell lines has now been approved, meeting our ambitions for quality and speed.”

CetuGEX™ was the second antibody in clinical stage produced in Glycotope´s own GMP facility in Heidelberg.

About CetuGEX™

CetuGEX™ 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 anti-tumor ADCC activity, bioavailability and contains no non-human immunogenic carbohydrate structures and facilitates treatment of a highly increased number of patients. This was achieved with Glycotope´s proprietary technology platform GlycoExpress™, a screening and high yield production system of glycoengineered human cell lines.

More Information:

Glycotope GmbH
Dr. Franzpeter Bracht
Robert-Roessle-Str. 10
13125 BERLIN
Germany

Tel.: +49-30-9489-2600
Fax: +49-30-9489-2609
eMail: news(at)glycotope.com

Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/glycotope-received-regulatory-approval-for-glycooptimized-and-fully-human-glycosylated-antibody-cetu