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