On May 5, 2025, Ichnos Glenmark Innovation (IGI), a global, fully integrated clinical-stage biotechnology company, announced that the U.S. FDA has granted Fast Track designation for its investigational drug ISB 2001. This designation is for the treatment of relapsed or refractory multiple myeloma (RRMM) patients who have undergone at least three prior therapies. The company plans to present clinical trial data at the 2025 ASCO Annual Meeting.
Ichnos Glenmark Innovation (IGI), a global, fully integrated clinical-stage biotechnology company based in New York, NY, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational drug ISB 2001. This breakthrough treatment targets relapsed or refractory multiple myeloma (RRMM) in adult patients who have undergone at least three prior lines of therapy.
Founded with a mission to develop innovative biologic therapies, IGI is advancing a promising pipeline focused on multispecific antibody technologies, particularly in oncology. Their proprietary BEAT® protein platform has enabled the development of ISB 2001, a trispecific antibody designed to target BCMA and CD38 on myeloma cells, and CD3 on T cells. The FDA’s Fast Track designation was granted based on the drug’s potential to address significant unmet medical needs in a patient population with limited treatment options.
The Phase 1 clinical study of ISB 2001 has shown promising results, with initial data presented at the 2024 American Society of Hematology (ASH) Annual Meeting. The full results from the dose-escalation portion of this trial will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 2, 2025.
ISB 2001’s Fast Track status opens the door for accelerated development, offering the potential for rolling reviews and Priority Review should it meet the necessary criteria. IGI is focused on bringing this first-in-class therapy to patients with RRMM, particularly those who have exhausted other treatment options, including CAR T-cell therapies and bispecific antibodies.
Cyril Konto, M.D., President and CEO of IGI, expressed the company’s excitement for the Fast Track designation, stating, “We are honored to receive this Fast Track designation and look forward to advancing ISB 2001 to help patients who continue to face disease progression despite available treatments.”
With the support of Fast Track status, ISB 2001 aims to provide a much-needed option for patients suffering from relapsed or refractory multiple myeloma, a condition that continues to challenge oncologists with limited treatment choices.
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