Multiple myeloma treatment granted Orphan Drug Designation

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Glenmark Pharmaceuticals’ bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies.

“Patients who are struggling with diseases like multiple myeloma are seeking new treatment options and innovative approaches. We believe the focus of our new company is essential to these patients and to the healthcare system,” said Alessandro Riva, MD, CEO of the new company. “As one of our first important pipeline milestones, we are excited that the FDA has recognised the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma.”

GBR 1342 is designed to bind to both CD3 on T cells and CD38, an antigen known to be implicated in hematological malignancies, on target cells. This activates T cells and redirects them toward CD38+ tumour cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumour cells.

A first-in-human, open-label, Phase I trial of GBR 1342 in multiple myeloma, is ongoing to assess the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity and additional measures of disease activity.