Glenmark Pharmaceuticals has dosed the first patient in a Phase l trial of GBR 1342 (NCT03309111) for the treatment of multiple myeloma.
The open-label trial’s primary endpoint is to evaluate the safety and tolerability of increasing doses of GBR 1342 in multiple myeloma patients until a maximum tolerated dose is reached.
The trial will also assess the biomarkers, immunogenicity and additional measures of anti-tumour activity.
Glenmark Pharmaceuticals president and chief medical officer Fred Grossman said: “Glenmark is committed to a new model of drug discovery that emphasises quality and a highly efficient approach to clinical development, and this milestone for GBR 1342 is an example of this approach in action.
“In just the last year, three of the company’s biologics, two of which are immuno-oncology agents, have begun clinical trials, which is a testament to the outstanding progress made by the global R&D workforce.”
The GBR 1342 is a CD38XCD3 bispecific monoclonal antibody based on Glenmark’s Bispecific Engagement by Antibodies based on the T-cell receptor (BEAT) bispecific antibody engineering platform.
The platform helps the company handle challenges in the production of bispecific monoclonal antibodies (bsAbs), as well as manufacture them at clinical and commercial scale.
The drug also represents Glenmark’s second immuno-oncology agent to enter clinical trial phase and is capable of simultaneously targeting CD38 antigen target implicated in multiple myeloma, in addition to the CD3 T-cell co-receptor.