Berlin, Germany, November 25, 2009 / b3c newswire / - 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” 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-GEX™ in a broad series of cancer indications.
About GT-MAB 2.5 GEX™
GT-MAB 2.5 GEX™ is a novel, exceptionally potent monoclonal antibody for the treatment of a broad variety of cancer indications. The antibody is directed against a novel tumor-specific combined carbohydrate-protein epitope present in a large number of patients of various cancers. GT-MAB 2.5 GEX™ shows three highly effective key modes of anti-tumor action: ADCC, phagocytosis and induction of apoptosis with an exceptionally high and specific tumor accumulation and tumor 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™, 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.
About Glycotope GmbH
GLYCOTOPE was founded in 2001 and focuses on the improvement and humanization of glycosylation structures on proteins, a comparatively new field in biotechnology. GlycoExpress™, the company’s proprietary technology permits making existing and new drugs more effective and tolerable in the human body, which is of considerable medical as well as economic importance. The current product range currently includes both proprietary antibodies for cancer therapy (e.g. GT-MAB 2.5-GEX™) and significantly improved versions (2nd generation) of antibodies and other therapeutic proteins already on the market.