Glycotope Medicates First Patients in Phase IIb Study for Novel Glycooptim?ized Anti-EGFR Antibody CetuGEX

Glycotope GmbH, one of the leading companies in glycobiology,has announced the enrollment and treatment of the first patients in its Phase IIb clinical trial of CetuGEX. CetuGEX is a novel anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) with optimized and fully human glycosylation for a greatly enhanced anti-tumour activity, reduced side effects and a broadening of patient and indication range.

The 1:1 randomized Phase IIb study is designed to evaluate the efficacy and safety of CetuGEX combined with chemotherapy compared to cetuximab plus chemotherapy as a first line treatment of patients suffering from recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). A total of approximately 240 SCCHN patients are planned to be enrolled at more than 40 sites in seven European countries and the US.

In a single agent Phase I trial CetuGEX was well tolerated and showed convincing therapeutic activity in treating patients with various solid cancers who were progressive at inclusion. Furthermore, there were noticeably lesser side effects (e.g. skin reactions) with CetuGEX compared to other EGFR targeting molecules.

In this trial CetuGEX demonstrated a clinical benefit rate (CBR) of 82% (22/28) of evaluable patients with several complete and partial responses (objective response rate ORR = 18%) over all dose ranges (12 to 1370 mg). Clinical benefit was often long lasting and occurred in patients where EGFR therapy had previously failed and in several non-typical EGFR indications. Longest benefit with >870 days is a complete response (CR) in a lung cancer patient (still ongoing), and 80% of the responses lasted over 400 days. CetuGEX(TM) was well tolerated with a low rate and low grade (only grade 1 or 2) of skin reactions (29% skin rash and 24% acneiform dermatitis, partially overlapping) compared to other EGFR targeting molecules.

"The initiation of this Phase IIb trial is an important milestone for Glycotope, not only in the clinical development of CetuGEX but also for our comprehensive pipeline of immune enhanced anti-cancer antibodies," said Dr Steffen Goletz, CEO, CSO and Founder of Glycotope. "Already as single agent in the Phase I clinical trial CetuGEX has achieved a larger series of strong, long-lasting responses and clinical benefit in patients with progressive solid cancers combined with lesser side effects, especially in respect to typical skin reactions of EGFR therapies. These results give us great confidence to enter into larger Phase IIb trials."