Glenmark presents preliminary biomarker data on GBR 1302

GBR 1302, a HER2xCD3 Bispecific Monoclonal Antibody, at the ASCO-SITC Clinical Immuno-Oncology Symposium

Glenmark Pharmaceuticals, a global pharmaceutical company, has announced a presentation of preliminary biomarker findings from a Phase 1 study of GBR 1302 (NCT02829372), an investigational bispecific antibody, at the ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco.

GBR 1302 is based on Glenmark’s proprietary BEAT platform and simultaneously targets HER2 and the CD3 T cell co-receptor. HER2 is overexpressed in a variety of solid tumors and is a validated therapeutic target. This first-in-human study is ongoing and enrolling adults with progressive HER2-positive solid tumors who have not responded to available treatment options. The study is evaluating the safety and tolerability of GBR 1302, and exploring its anti-tumor activity.

“The discovery of agents targeting HER2 has greatly improved the treatment of a variety of cancers where it is overexpressed,” said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals.

“Investigational treatments like bispecific antibodies that target a broad spectrum of HER2 expression levels on a variety of tumor tissues while simultaneously engaging tumor-infiltrating T cells have the potential to advance the treatment of these tumors, and may fulfill a substantial unmet medical need. We are pleased to share this early data characterizing the clinical activity of GBR 1302 at the ASCO-SITC symposium.”

Patients enrolled in the study receive intravenous GBR 1302 on Day 1 and Day 15 in 28-day treatment cycles at escalating doses until maximum-tolerated dose is achieved. Preliminary biomarker data demonstrate modulation of peripheral T cell populations and cytokines. Some subjects treated at the higher doses experienced cytokine release syndrome, which was mild and transient. Dose escalation is ongoing. These data will be presented during the Trials in Progress Poster Session on January 25th from 11:30 AM – 1:00 PM and 5:30 –6:30 PM in San Francisco, CA.

“These preliminary data for GBR 1302 tell us the spikes in peripheral blood cytokines and a drop in T cell levels suggest the potential for T cell activation,” said lead study investigator Martin Wermke, MD, University Hospital Carl-Gustav-Carus, Dresden, Germany. “As such, we are encouraged by these initial findings and look forward to continuing this important study which will help us more fully understand the science behind the mechanism of action and the potential for clinical activity.”