Glenmarks multiple myleoma treatment designated orphan drug in USA

Glenmark Pharmaceuticals won Orphan Drug Designation from USFDA to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies.

Derived from the Glenmarks own Bispecific Engagement by Antibodies based on the T cell receptor technology, GBR 1342 is being investigated for the treatment of multiple myeloma, the company said Tuesday in a press release. The candidate is one of five clinical-stage assets in the pipeline of Glenmark’s new innovation company.

Glenmark designs GBR 1342 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+ tumor cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumor cells, Glenmark said.

Furthermore, Glenmark is testing it in an open-label, Phase 1 trial in multiple myeloma, first in human, of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity.

Alessandro Riva, CEO of the Glenmarks US-based innovative company said: “As one of our first important pipeline milestones, we are excited that the FDA has recognized the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma.”

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and – upon regulatory approval – 7 years of market exclusivity.