IGI (Ichnos Glenmark Innovation), a global, fully integrated clinical-stage biotechnology company focused on developing multispecifics in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ISB 2001.
This important designation was granted for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
ISB 2001 is an investigational trispecific antibody therapeutic that targets BCMA and CD38 on myeloma cells and CD3 on T cells.
ISB 2001 is currently being evaluated in a Phase 1 dose-expansion study.
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