Glenmark Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its proprietary drug GBR 1342 to be investigated as a treatment for myeloma patients. GBR 1342 is a humanised bi-specific monoclonal antibody designed to activate the immune system by redirecting T cells to myeloma cells through the simultaneous engagement of CD38 on myeloma cells and CD8 on T cells. The first-in human Phase I trial will be a dose-escalation and expansion study in relapsed and/or refractory myeloma patients who have no further treatment options to determine the safety and maximum tolerated dose of GBR 1342.
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