Glycotope received regulatory approval for glycooptimized and fully human glycosylated antibody CetuGEX
“For Glycotope, the approval of CetuGEX, our 2nd 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 2nd cell line of Glycotope´s glycooptimization platform GlycoExpressTM 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.
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 antitumor ADCC activity, bioavailability and contains no non-human immunogenic carbohydrate structures and facilitates treatment of a highly increased number of patients.
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