The presentations include preclinical and translational data on GBR 1302, a HER2xCD3 bispecific antibody, and a Trials in Progress poster on GBR 1342, a CD38xCD3 bispecific antibody
Glenmark Pharmaceuticals announced the presentation of data from two assets in its immuno-oncology portfolio at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO). These presentations include preclinical and translational data on GBR 1302, a HER2xCD3 bispecific antibody, and a Trials in Progress (TIP) poster on GBR 1342, a CD38xCD3 bispecific antibody.
GBR 1302 is Glenmark’s lead immuno-oncology candidate, currently in a first-in-human trial to determine maximum tolerated dose (MTD) in an all-comers population of patients with a variety of HER2 positive cancers. This Phase 1 trial is being expanded to explore higher doses of GBR1302 and to examine potential clinical benefit of a once-weekly dosing regimen. Enrollment for the GBR 1302 clinical trial is currently ongoing in the US and Germany.
In parallel, an ex vivo translational study has recently been completed utilising a fully human, clinically validated diagnostic platform that delivers treatment response predictions to identify responder context to GBR 1302 in metastatic breast and gastric cancer tissue biopsies. The translational study further investigates the novel Mechanism of Action (MOA) of GBR 1302 in a tumour microenvironment and its impact on expansion of memory and effector CD8+/CD4+ T cells to inform precise patient selection. The translational study also addresses the effect of T cell engagers in combination with check point inhibitors (e.g., anti-PD1/PDL1).
“By relying on a combination of translational data and clinical adaptive design, Glenmark is rapidly advancing potential first-in-class immuno-oncology candidates,” said Fred Grossman, President and Chief Medical Officer, Glenmark Pharmaceuticals. “We are pleased to share these emerging data and updates on our immuno-oncology pipeline at the ASCO Annual Meeting.”
Based on preliminary data from the Phase 1 clinical study, and ex vivo translational studies, a Phase 1b/2 study is currently being designed and will include an expansion cohort of HER2 positive metastatic breast cancer patients. The expansion cohort will evaluate the safety, pharmacokinetics and antitumour activity of GBR 1302 and is intended to generate robust and comprehensive translational data.