FDA clears CD38/CD3 bi-specific antibody for treatment of MM in phase I clinical trials

On the 15^th May 2017, Glenmark Pharmaceuticals’ bi-specific antibody (GBR 1342) was cleared by the U.S. Food and Drug Administration (FDA) for further investigation in phase I trials of Multiple Myeloma (MM) patients, who have received prior treatment. The trial will assess dose escalation and safety.

GBR 1342 is a modality developed using Glenmark’s BEAT^® (Bispecific Engagement by Antibodies based on the T cell receptor) technology, which has optimized engineering features, such as compatibility with standard production processes and high production yields, as well as low immunogenic potential and the ability to modify Fc-mediated effector function.

Specifically, GBR 1342 uses a CD3 arm to engage cytotoxic T cells, then directs them towards the malignant myeloma cells using a second CD38 binding arm, therefore harnessing the patient’s own immune system to target the myeloma cells. Several bi-specific antibodies have recently been reported but are still in the early development phase, so this is very much a positive step forward.