Italian and German regulatory approval for 'GlycoExpress' Technology and first clinical trial with antibody GT-MAB 2.5-GEX TM
German Biotech company Glycotope, has received regulatory approval by German 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 '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” 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.
About GT-MAB 2.5-GEX
GT-MAB 2.5-GEXTM is a novel, exceptionally potent monoclonal antibody for the treatment of a broad variety of cancer indications. The antibody is directed against a novel tumour-specific combined carbohydrate-protein epitope present in a large number of patients of various cancers. GT-MAB 2.5-GEXTM shows three highly effective key modes of anti-tumour action: ADCC, phagocytosis and induction of apoptosis with an exceptionally high and specific tumour accumulation and tumour killing already at doses as low as 0.5 mg/kg.
The antibody’s fully human glycosylation is optimized to yield a largely improved ADCC activity, bioavailability and no non-human immunogenic carbohydrate structures. This was achieved by Glycotope´s proprietary technology platform GlycoExpress TM, a screening and high yield production system of glycoengineered human cell-lines that allows significant enhancement of therapeutic potency by optimizing a protein’s glycosylation in various aspects.
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