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Glenmark to launch phase 1 trial in solid tumors for anti-myeloma drug

Press Trust of India/New Delhi 08 Nov 18 | 11:40 AM

Glenmark Pharmaceuticals Thursday said it will launch phase 1 trial in solid tumors for its bispecific antibody GBR 1342, indicated for the treatment of multiple myeloma.

"The company intends to file an Investigational New Drug (IND) application for GBR 1342 in solid tumors and initiate a clinical trial in 2019," the company said in a regulatory filing.

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Glenmark Pharma said the decision to launch clinical trial is driven by recent findings derived from a non-interventional human study.

"Our work with innovative immunotherapeutics such as T cell re-directing bispecific antibodies necessitates detailed analyses to fully-understand and assess the potential opportunities presented by the candidates in our pipeline, said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals.

An ongoing first-in-human, open-label, phase 1 trial of GBR 1342 in multiple myeloma, is assessing the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity, it added.

Glenmark said GBR 1342 is one of three investigational immuno-oncology agents based on Glenmark's proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) platform.

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