Ichnos Glenmark Innovation Receives FDA Fast Track Designation for ISB 2001 in Multiple Myeloma
Ichnos Glenmark Innovation (IGI) announced today that the US FDA has granted Fast Track designation for ISB 2001, an investigational trispecific antibody targeting relapsed or refractory multiple myeloma (RRMM) in adult patients who have received at least three prior lines of therapy.
Multiple Myeloma: A Challenging Landscape
Multiple myeloma is a hematologic cancer characterized by the uncontrolled proliferation of plasma cells in the bone marrow. Nearly all patients with relapsed or refractory multiple myeloma ultimately experience disease progression, with limited treatment options once approved therapies are exhausted.
Innovative Therapeutic Approach
ISB 2001 is a first-in-class trispecific T-cell engager that simultaneously targets:
- BCMA and CD38 on myeloma cells
- CD3 on T cells
Developed using IGI's proprietary BEAT® protein platform, the antibody is engineered to enhance tumor targeting while potentially reducing off-tumor toxicity compared to first-generation bispecific antibodies.