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.
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.
Fig.1 Site-specific glycoengineering of cetuximab for enhanced ADCC activity.
Glyco-engineered omuzotuximab is thought to have therapeutic activity against EGFR-positive tumors because of:
Fig.2 Mechanism of action of Tomuzotuximab.
|NCT ID||Status||Conditions||Lead Sponsor||Phase||Update Time|
|NCT03360734||Recruiting||Solid Tumor, Adult||Glycotope GmbH||Phase 1||October 2019|
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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.
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