Tomuzotuximab

Overview

Tomuzotuximab (or CetuGEX®; Cetuximab biobetter - Glycotope; GT-MAB 5.2-GEX) is a novel monoclonal antibody (mAb) directed against the epidermal growth factor receptor (EGFR) with optimized and fully human glycosylation. Tomuzotuximab is optimized for glycosylation in its Fc domain to promote antibody-dependent cell-mediated cytotoxicity (ADCC). EGFR is overexpressed on the cell surface in a variety of tumor types and acts under anti-tumor mechanisms: strong ADCC, inhibition of proliferation by receptor blockade, and induction of apoptosis. A clinical phase I dose escalation study involving Tomuzotuxima is ongoing to investigate the efficacy of this antibody in the treatment of metastatic head and neck squamous cell carcinoma.

ADCC Enhancement Technology for Tomuzotuximab

Tomuzotuximab is a glycoengineered second generation antibody of parental cetuximab. The glycosylation process used to develop this agent is achieved by altering the glycosylation in the Fc region of the mAb molecule, resulting in a significant enhancement of immunogenicity and hence a stronger ADCC response.

Site-specific glycoengineering of cetuximab for enhanced ADCC activity. Fig.1 Site-specific glycoengineering of cetuximab for enhanced ADCC activity.

Mechanism of Action of Tomuzotuximab

Glyco-engineered omuzotuximab is thought to have therapeutic activity against EGFR-positive tumors because of:

Mechanism of action of Tomuzotuximab. Fig.2 Mechanism of action of Tomuzotuximab.

Glycan Analysis of Tomuzotuximab

Tomuzotuximab

Antigen Binding Characteriztion

Tomuzotuximab

ADCC Activity

Tomuzotuximab

Clinical Anti-tumor Activity

Tomuzotuximab

Clinical Development Status

NCT ID Status Conditions Lead Sponsor Phase Update Time
NCT03360734 Recruiting Solid Tumor, Adult Glycotope GmbH Phase 1 October 2019

For more detailed information, please do not hesitate to contact us.

Reference

  1. John P.; et al. Site-selective chemoenzymatic glycoengineering of Fab and Fc glycans of a therapeutic antibody. PNAS. 2018, 115 (47) 12023-12027; first published November 5, 2018.

RESOURCES

Creative Biolabs provides luciferase-based ADCC assay. This Jurkat cell based assay is pioneered by Creative Biolabs, and the methodology is very well accepted by the field. See attached ADCC Reporter Assay Protocol for further details. 

All products and services are for Research Use Only. Do Not use in humans.

CASE STUDY

ADCC Assay WT vs AfucoTM Mabs  Visit

Resource

Antibody Fc Engineering: Towards Better Therapeutics  Visit

ONLINE INQUIRY

Creative Biolabs has established a team of customer support scientists ready to discuss ADCC/CDC optimization strategies, antibody production, bioinformatics analysis and other molecular biology/biotechnology issues.

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