Glycotope receives regulatory approval for GlycoExpress Technology and initiates clinical trial with antibody GT-MAB 2.5-GEX
Glycotope GmbH, has received regulatory approval by Germany and Italian regulatory authorities for a Phase I study of Glycotope´s lead antibody GT-MAB 2.5-GEXTM for the treatment of various solid cancers. The approvals further underline the suitability of Glycotope´s proprietary GlycoExpressTM technology for the improvement, glycooptimization and high yield production of therapeutic proteins for the use in humans.
“The approval of GT-MAB 2.5-GEX as well as the regulatory approval of the GlycoExpress production technology based on its glycoengineered human cell lines represents a significant milestone for the company” says Steffen Goletz, PhD, Founder, CEO and CSO of Glycotope. “After generating very encouraging data in pre-clinical studies, we are now looking forward to demonstrate the importance of glycosylation in the clinic by generating a substantial benefit to patients.”
The Phase I study will evaluate the safety and tolerability of GT-MAB 2.5-GEXTM in a broad series of cancer indications.
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