GBR 1342 is an antibody-based therapy being developed by Glenmark Pharmaceuticals to treat multiple myeloma and other cancers that overproduce CD38, a protein normally found on the surface of several immune cells such as T-cells and B-cells.
The U.S. Food and Drug Administration (FDA) accepted an investigational new drug (IND) application by the company for GBR 1342 in May 2017, leading to the initiation of a Phase 1 clinical trial testing the treatment in people with multiple myeloma.
How GBR 1342 works
GBR 1342 is a bispecific antibody meaning that it can bind to two different molecules at the same time. It is based on the company’s proprietary technology platform, called BEAT (Bispecific Engagement by Antibodies based on the T cell receptor).
GBR 1342 is able to simultaneously bind both to CD38 and CD3, a protein complex found on the surface of T-cells. In this way, it can potentially activate T-cells, promoting an immune response against CD38-producing cancer cells that may lead to their targeted killing.
In preclinical studies using cancer cells derived from multiple myeloma patients, GBR 1342 showed a more potent anti-cancer effect than Darzalex (daratumumab), an FDA-approved antibody against CD38, the company reports.
GBR 1342 in clinical trials
An open-label Phase 1 study (NCT03309111) began in October 2017. The trial aims to enroll about 125 previously treated multiple myeloma patients, and will assess the safety and tolerability of GBR 1342.
This first-in-human study will be conducted in two parts: a dose-escalation part to determine the treatment’s safety profile and maximum tolerated dose (MTD), followed by a cohort expansion part that will further assess GBR 1342’s safety profile and take preliminary measures of its efficacy. Treatment will be given by intravenous infusion in 28-day cycles, with escalating doses on days one and 15.
The study is recruiting participants at select sites in the U.S. and Germany and is expected to finish in 2020. Information is available by clicking on its identification number.
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