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The United States (US) Food & Drug Administration (FDA) have granted GBR 1342 orphan drug designation (ODD) for the treatment of multiple myeloma (MM).1,2 The maximum tolerated dose (MTD) of GBR 1342 is currently being investigated in an open-label, phase I trial, H2 CY 2019.1,3 The trial will evaluate biomarkers, immunogenicity and disease activity.1
GBR 1342 is created using “bispecific engagement by antibodies based on T-cell receptor” (BEAT®) technology.1,3 This method of producing bispecific antibodies is designed to create products with a low immunogenicity profile.
GBR 1342 is a bispecific monoclonal antibody that binds two targets; CD3 on T-cells and CD38 on target tumor cells. It subsequently induces T-cell activation and directs them to kill CD38+ tumor cells.1,3
CD38 is a glycoprotein with ectoenzymatic functions which is highly expressed on MM cells, cells of hematopoietic origin and in solid tumors. One advantage of anti-CD38 therapy therefore, is that it may have a role across different malignancies. However, since CD38 is also expressed on non-malignant hematopoietic cells such as natural killer (NK) cells, B-cells and activated T-cells, it may also have adverse effects on the activity of normal cells.4
The first report from the phase I study was published on 1st June 2018 in the Journal of Clinical Oncology.5 This is a first-in-human trial (NCT03309111):6
References
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