Glenmark Pharmaceuticals Receives FDA Clearance of IND for GBR 1302-BEAT Phase I Trial

Mahwah : Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to initiate a phase I study of its lead candidate, GBR 1302-BEAT™, in patients with HER2+ cancers. The company plans to expand the ongoing phase I clinical study to include sites in the United States for this potential first-in-class treatment, a humanized, bispecific monoclonal antibody targeting HER2 and CD3, based on the BEAT™ (Bi-specific Engagement of Antibodies based on the T cell receptor) technology platform.

Preclinical studies suggest GBR 1302 may have activity against a range of HER2-expressing tumor types, including breast, gastric and other cancers. Some of these findings were recently presented in an oral and poster presentation at the 4^th ESMO (European Society of Medical Oncology) Symposium on Immuno-Oncology in Lausanne, Switzerland in November (ESMO Press Release).