Glycotope Doses First Patients in Phase IIb Study with PankoMab-GEX(TM) for the Maintenance Therapy of Ovarian Carcinoma

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• First therapeutic glycooptimized antibody against a novel tumor-specific carbohydrate-protein mixed epitope on a series of cancer cells

• Excellent tolerability, no significant toxicity and strong anti-tumor activity observed as single agent in a Phase I trial

Berlin, Germany, November 25th, 2013 - Glycotope GmbH, a global leader in developing therapeutic antibodies targeting glycosylated epitopes on cancer cells and optimizing the glycosylation of biopharmaceuticals, today announced the enrollment and treatment of first patients in its Phase IIb clinical trial of PankoMab-GEX^TM for maintenance therapy of patients with ovarian cancer. PankoMab-GEX^TM is the first fully human glycosylated and glycooptimized antibody against a novel tumor-specific carbohydrate-protein mixed epitope (TA-MUC1) abundantly present on a larger set of tumor indications, metastasis and cancer stem cells, and virtually absent on normal cells.

The double-blind, randomized, placebo-controlled Phase IIb study is designed to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX^TM. A total of approximately 210 patients suffering from recurrent ovarian carcinoma and at least stable under current chemotherapy are planned to be enrolled at 41 sites in seven European countries and Russia.

The primary endpoint of the Phase IIb trial is progression free survival. Secondary endpoints include further efficacy data such as time to progression, objective response rate, clinical benefit rate and overall survival as well as pharmacokinetic and safety data.

PankoMab-GEX^TM showed excellent tolerability, no significant toxicity and strong anti-tumor activity in a single agent Phase I trial in patients with progressive disease and with various indications including ovarian and lung carcinoma. Patients with progressive ovarian cancer which were resistant or sensitive to their most recent platinum containing therapy and with no further treatment option showed in 80% of the cases clinical benefit with an average duration of more than 210 days.