Glycotope Initiates Phase Ib Trial of Combination of Proprietary Anti-Tumor Antibodies
· GATTO Study to Evaluate Gatipotuzumab and Tomuzotuximab in Advanced and/or Metastatic Solid Tumors
· First patient enrolled in international, multicenter study
· First study to evaluate the potential of the combination two of Glycotope's clinical assets
Berlin, Germany, 22 December 2017 - Glycotope GmbH [Glycotope], a clinical-stage immuno-oncology company built on world-leading glyco-biology expertise, today announces it has enrolled the first patient in its international GATTO study which combines two of the Company's immuno-oncology assets derived from its world-leading glycobiology expertise.
The phase Ib trial will evaluate the feasibility, safety and efficacy of the combination of Glycotope's anti-TA-MUC1 antibody (Gatipotuzumab) and anti-EGFR antibody (Tomuzotuximab) in patients with advanced and/or metastatic solid tumors with measurable disease after failure of standard treatment options.
GATTO is an international, multicenter phase Ib trial expected to enroll patients in Germany, Italy and Spain. The combination of Gatipotuzumab and Tomuzotuximab is based on a strong preclinical rationale and clinical evidence from the prior studies conducted with each agent alone.
"We are pleased to have enrolled the first patient in this innovative and interesting trial. There is as strong rationale for this combination and we are excited to learn more about its efficacy, thanks also to an extensive translational research program," said Prof. Ulrich Keilholz, MD, Acting Director of the Charité Comprehensive Cancer Centre, Berlin, Germany. "The trial aims to confirm in selected cancer patients the preclinical synergy observed in combining anti-EGFR and anti TA-MUC1 targeting."
"This trial will see the glycoengineered antibodies derived from Glycotope's innovative platform tested in the challenging clinical setting of patients with advanced/metastatic oncological disease," said Dr. Alfredo Zurlo, MD, Managing Director and Chief Medical Officer of Glycotope GmbH. "Thanks to careful patient selection based on biomarkers the aim is to identify those who can achieve a clinically relevant benefit using targeted immunotherapies."
"The GATTO trial is a significant next step in Glycotope's presence in the field of immuno-oncology," said Henner Kollenberg, Managing Director of Glycotope GmbH. "Based on our understanding of the optimization and targeting of antibodies, a strong pre-clinical pipeline, and clinical experience and expertise, Glycotope will continue to expand in this strategic focus area."
In the GATTO study patients with metastatic solid tumors, such as breast, lung, colorectal and gynecological cancers, will receive the two antibodies until first tumor progression. A comprehensive translational research program will allow us to identify the patients most likely to benefit from the innovative treatment combination and support further clinical development.
For more information about the GATTO trial, visit www.clinicaltrials.gov
About Tomuzotuximab
Tomuzotuximab (previously known as CetuGEX®) is an immune-enhanced monoclonal antibody (mAb) against the epidermal growth factor receptor (EGFR) with optimized and fully human glycosylation. Tomuzotuximab works via several anti-tumor mechanisms of action: a strong antibody dependent cellular toxicity (ADCC), proliferation inhibition via receptor blockage and induction of apoptosis. Thanks to the optimization of a series of sugar determinants, in pre-clinical studies Tomuzotuximab has shown to be more active in eliciting anti-tumor ADCC compared to cetuximab. This enhanced potency may increase the number of patients with EGFR expressing tumors who benefit from treatment.
About Gatipotuzumab
Gatipotuzumab (previously known as PankoMab-GEX®) is an anti-tumor antibody developed through Glycotope's proprietary glyco-epitope targeting and glycooptimization technologies. Gatipotuzumab enables tumor-specific binding to a carbohydrate-induced conformational epitope, the TA-MUC1 (tumor-associated MUC1), which is present across a variety of high prevalence carcinomas. It has thus potential in the treatment of several cancer types and as a platform for the development of multiple further oncology and immuno-oncology products including antibody drug conjugates (ADC) and bi-specifics activating the immune system.
About Glycotope
Glycotope, founded in 2000 in Berlin, focuses on the development of innovative immune-oncological products for the treatment of various cancer types using their GlycoBody and GlycoExpress® technologies. Next to the clinical program the Company's pipeline includes preclinical antibody biopharmaceuticals for various oncological indications.
Glycotope's GlycoExpress® (GEX®) platform allows glyco-optimization and high yield production of a variety of fully human glycosylated biopharmaceuticals such as antibodies, glycoprotein hormones, coagulation factors and cytokines, and by using a toolbox of glyco-engineered proprietary human cell lines that allow for optimization of a whole series of different determining sugars. In addition, the GEX® platform can be used for in process glycosylation control. Visit http://www.glycotope.com/.
Contact:
Glycotope GmbH
Dr. Alfredo Zurlo
Phone: +49 (0) 30 -9489-2600
Email: Alfredo.Zurlo@glycotope.com
Consilium Strategic Communications
Chris Gardner, Jonathan Birt, Jessica Hodgson and Hendrik Thys
Phone: +44 (0) 20 3709 5700
Email: glycotope@consilium-comms.com