Glycotope received regulatory approval for glycooptimized and fully human glycosylated antibody CetuGEX
Glycotope GmbH, 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 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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