Glycotope Receives Regulatory Approval For GlycoExpress Technology

Glycotope 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, glycooptimisation and high yield production of therapeutic proteins for the use in humans.

Steffen Goletz, founder, CEO and CSO of Glycotope, said: “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. 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 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 0.5mg/kg.