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Glycotope Received Regulatory Approval for Antibody CetuGEX

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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 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.