Glenmark's GBR 1342 Receives the US FDA's Orphan Drug Designation for Multiple Myeloma
Shots:
- The US FDA has granted Orphan drug designation to GBR 1342 for the treatment of multiple myeloma who have received prior therapies. The P-I study will assess the safety & tolerability of increasing doses of GBR 1342 and will evaluate biomarkers- immunogenicity- and additional measures of disease activity
- The ODD is granted to novel drugs and biologics which are intended for the safe and effective treatment- diagnosis or prevention of rare diseases affecting people less than 200-000 in the US
- GBR 1342 is a bispecific investigational Ab based on Glenmark’s BEAT technology and is designed to bind to both CD3 and CD38- activating T cells and redirecting them toward CD38+ tumor cells found in multiple myeloma
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