Glenmark Pharmaceuticals, a global pharmaceutical company, 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 utilizing 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 at 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.

Details regarding the date and times of these presentations are: GBR1302: Effect of CD3-HER2, a bispecific T cell engager antibody, in trastuzumab-resistant cancers -- Session: Developmental Therapeutics – Immunotherapy – Monday, June 4th 1:15-4:45 PM.

Phase 1, multicenter, open-label study of single-agent bispecific antibody t-cell engager GBR 1342 in relapsed/refractory multiple myeloma -- Session: Tumour Biology --Monday, June 4th --8:00 – 11:30 AM.

Glenmark's pipeline currently includes three immuno-oncology candidates being studied in a wide range of tumor types. These include three bispecific monoclonal antibodies (bsAbs). GBR 1302, a HER2xCD3 bsAb, targets HER2 expressing tumours including those not responsive to standard of care; GBR 1342, a CD38XCD3 bsAb targeting CD38 positive tumours including haematologic malignancies and solid tumours; and GBR 1372, an EGFRxCD3 bsAb targeting EGFR positive tumours including those resistant to standard of care.

BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) is Glenmark's proprietary technology for the production of bsAbs. With BEAT technology, Glenmark's scientists have been able to overcome past production obstacles encountered with bsAbs, and can efficiently manufacture these molecules at clinical and commercial scale. Preclinically, BEAT bsAbs demonstrate the potential for more potent activity compared to existing therapeutic antibodies. Additionally, structural similarity to naturally-occurring antibodies may result in a normalized IgG half-life and less immunogenicity. GBR 1302, GBR 1342 and GBR 1372 are based on BEAT technology.