Glenmark Initiates Clinical Study for GBR 1342

Glenmark Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to initiate a Phase 1 study of GBR 1342, a humanized, bispecific monoclonal antibody (bsAb) being studied for the treatment of multiple myeloma in patients who have received prior therapies. GBR 1342 is designed to activate the patient's immune system by redirecting immune cells towards tumor tissue, which may lead to targeted destruction of tumors. It is based on Glenmark's proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform.

"This is an exciting time for Glenmark as our flagship biotechnology platform and antibody science are beginning to become a reality for patients, now that we have a second oncology candidate entering clinical trials," Kurt Stoeckli, President and Chief Scientific Officer at Glenmark said. "While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing."

The first-in-human Phase 1 study of GBR 1342 will enroll subjects with multiple myeloma who have exhausted available therapies. The study is being conducted in two parts: the first part is a dose escalation to determine the safety profile and maximum tolerable dose; the second is an expansion cohort treated at maximum tolerable dose to further investigate the safety profile and preliminary efficacy of GBR 1342.

GBR 1342 simultaneously engages CD38, a proven target in multiple myeloma, and the CD3 molecule on T cells. GBR 1342 is also being considered for the treatment of other malignancies.