Glycotope Expands Phase Ib Trial of Combination of Proprietary Anti-Tumor Antibodies to Include Marketed Anti-Tumor Antibodies
25.03.2019 / Glycotope GmbH (Glycotope or the Company), a clinical-stage oncology/immuno-oncology company built on world-leading glycobiology expertise, today announces it has enrolled the first patient in an expansion of its ongoing Phase Ib international GATTO study investigating the combination of Glycotope’s anti-TA-MUC1 antibody (Gatipotuzumab) and anti-EGFR antibody (Tomuzotuximab).
The phase Ib trial expansion will evaluate the feasibility, safety and efficacy of the combination of Gatipotuzumab with either Tomuzotuximab or a marketed anti EGFR antibody in patients with solid tumors such as metastatic colorectal, lung, breast and head and neck cancers with measurable disease after failure of standard treatment options.
GATTO is an international, multicenter phase Ib trial enrolling patients in Germany, Italy and Spain. The combination of Gatipotuzumab with Tomuzotuximab or a marketed anti EGFR antibodies is based on a strong preclinical rationale and preliminary clinical evidence from the first 20 patients enrolled in the study.
“We are pleased to have enrolled the first patient in this innovative and interesting trial expansion which will enable us to build on the preliminary clinical evidence from the first 20 patients enrolled in the study. We are excited to learn more about Gatipotuzumab’s efficacy when combined with anti EGFR antibodies,” said Dr. Alfredo Zurlo, MD, external Medical Head of Glycotope GmbH. “The trial aims to confirm in selected cancer patients the preclinical synergy observed in combining anti-EGFR and anti TA-MUC1 targeting.”
“The GATTO trial extension further highlights the potential and wide applicability of gatipotuzumab” said Henner Kollenberg, Managing Director of Glycotope GmbH. “We believe the versatility of our technology platform combined with our world-leading glycobiology expertise and clinical experience in oncology and primarily immuno-oncology leaves us well placed to further strengthen our position in the field.”
The GATTO study has been registered with the European Medical Agency under the EudraCT number 2017-001609-33
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.
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.
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/.
Consilium Strategic Communications
Chris Gardner, Chris Welsh
Quelle: Glycotope GmbH