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 4th ESMO (European Society of Medical Oncology) Symposium on Immuno-Oncology in Lausanne, Switzerland in November (ESMO Press Release).
“We believe GBR 1302 may have utility across a broad range of HER2+ tumor types. Data from preclinical studies are very encouraging,” said Fred Grossman D.O., President and Chief Medical Officer at Glenmark Pharmaceuticals Inc. “Based on its novel mechanism of redirecting T cells to HER2+ cancer cells, GBR 1302 has the potential to become an important therapy for previously treated and, eventually, newly diagnosed HER2+ tumors.”