Glycotope GmbH, a leading German Biotech company, has received regulatory approval by Germany and Italian regulatory authorities for a phase-I study of Glycotope´s lead antibody GT-MAB 2.5-GEX for the treatment of various solid cancers. The approvals further underline the suitability of Glycotope´s proprietary GlycoExpress 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,” said Steffen Goletz, 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-GEX in a broad series of cancer indications.
GT-MAB 2.5 GEX is a novel, exceptionally potent monoclonal antibody for the treatment of a broad variety of cancer indications.
Glycotope was founded in 2001 and focuses on the improvement and humanization of glycosylation structures on proteins, a comparatively new field in biotechnology.