DGAP-News: Glycotope GmbH: Glycotope medicates first

DGAP-News: Glycotope GmbH / Key word(s): Study Glycotope GmbH: Glycotope medicates first patients in Phase IIb study for novel glycooptimized anti-EGFR antibody CetuGEX(TM) to treat squamous cell carcinomas of the head and neck (SCCHN) 02.04.2014 / 10:00 --------------------------------------------------------------------- - CetuGEX(TM) demonstrates enhanced anti-tumor activities, reduced side effects and a broader patient and indication range Berlin, Germany, April 2, 2014 - Glycotope GmbH, one of the leading companies in glycobiology, announced today the enrollment and treatment of the first patients in its Phase IIb clinical trial of CetuGEX(TM). CetuGEX(TM) is a novel anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) with optimized and fully human glycosylation for a greatly enhanced anti-tumor 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(TM) 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 USA. In a single agent Phase I trial CetuGEX(TM) 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(TM) compared to other EGFR targeting molecules. In this trial CetuGEX(TM) 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(TM) 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(TM) 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." About CetuGEX(TM) CetuGEX(TM), glycooptimized GT-MAB 5.2-GEX(TM), is a novel immune enhanced anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) for the treatment of non small cell lung cancer (NSCLC), metastatic colorectal cancer (CRC), head and neck cancers as well as gastric and renal cancers with optimized and fully human glycosylation. CetuGEX(TM) expresses several anti-tumor modes of action, a very strong antibody dependent cellular toxicity (ADCC), efficient proliferation inhibition via receptor blockage and apoptosis induction. Based on the optimization of a series of sugar determinants CetuGEX(TM) is 10 to 250-fold more active in anti-tumor ADCC compared to Cetuximab making it highly potent for patients of all ADCC receptor allotypes and KRAS mutant patients. The molecule has an optimized bioavailability, lacks foreign immunogenic carbohydrates and has shown a largely improved side effect profile compared to other EGFR antibodies such as low grade and low incidence of skin rash in combination with a strong single agent activity. These improvements aim for an expansion of the number of suitable patients as well as indications. Cetu-GEXTM is the second of Glycotope's antibodies in Phase IIb. About Glycotope Glycotope specializes in the glycosylation of proteins and is one of Germany's largest independent biotech companies. Glycotope has a broad portfolio of drugs in clinical development, including the new cancer drugs, PankoMab-GEX(TM) and CetuGEX(TM), both in Phase IIb trials, and TrasGEX(TM), which has successfully completed its Ph I/IIa trial, as well as its improved fertility hormone, FSH-GEX(TM), which is expected to begin two Phase III clinical trials in 2014. In addition, the Company owns various antibody and non-antibody biopharmaceutical candidates in preclinical development. All products were glycooptimized, fully human glycosylated and produced with exceptional quality, reproducibility and yields using the validated GlycoExpress(TM) (GEX(TM)) technology. This innovative technology enables Glycotope to increase the effectiveness, tolerability and affordability of a large number of drugs and expands their patient populations and indications. Founded in 2001 on the Campus of the Max-Delbrück-Center for Molecular Medicine in Berlin-Buch, Glycotope now has more than 180 employees at two locations in Berlin and Heidelberg and covers the entire workflow from discovery, molecule optimization, clone and process development, preclinical and clinical drug development including GMP production. The Company's investors include Munich-based Jossa Arznei GmbH (Strüngmann Group) and ELSA GmbH (Eckert Life Science Accelerator) in Berlin, which have provided total financing in excess of EUR 130 million. Contact: Glycotope GmbH Dr. Franzpeter Bracht, COO Robert-Roessle-Str. 10, D-13125 Berlin, Germany Phone: +49-(0)30 94 89-2600 Fax: +49-(0)30 94 89-2609 Email: franzpeter.bracht@glycotope.com Website: www.glycotope.com End of Corporate News --------------------------------------------------------------------- 02.04.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. 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