IGI’s relapsed/refractory multiple myeloma drug wins fast track status
ISB 2001 is being tested in a Phase 1 study that seeks to enroll about 80 adults
The U.S. Food and Drug Administration (FDA) has granted fast track status to ISB 2001, an experimental therapy for difficult-to-treat multiple myeloma.
The designation covers the use of ISB 2001 in people with myeloma that is relapsed or refractory, meaning the disease has come back or failed to respond, after at least three prior lines of treatment that include an immunomodulatory medication, a proteasome inhibitor, and an anti-CD38 antibody.
The FDA gives fast track status to experimental medicines with the potential to fill unmet medical needs in the care of serious conditions. With this designation, ISB 2001’s developer Ichnos Glenmark Innovation (IGI) will be allowed more frequent communication with the FDA during the drug’s development.
“We are honored to receive this fast track designation and look forward to working closely with the FDA to advance [ISB 2001] with the goal of delivering a first-in-class therapy for patients with relapsed or refractory multiple myeloma,” Cyril Konto, MD, president and CEO of IGI, said in a company press release.
What is ISB 2001?
ISB 2001 is a trispecific antibody therapeutic that’s made to simultaneously target two proteins on myeloma cells — BCMA and CD38 — while also targeting a protein called CD3 on cancer-killing immune cells known as T-cells. By binding all three proteins at the same time, ISB 2001 should trigger T-cells to attack and kill myeloma cells, but not attack healthy cells that may express either BCMA or CD38.
“Our trispecific candidate is designed to enhance tumor targeting while reducing on-target, off-tumor toxicity,” Konto said.
ISB 2001 is being tested in a Phase 1 study (NCT05862012) that seeks to enroll about 80 adults with relapsed or refractory myeloma who’ve had at least three lines of treatment. The study is enrolling participants at sites in the U.S. and Australia.
Preliminary data from the study, announced late last year, showed that 15 of 18 patients given an active dose of ISB 2001 responded to treatment, meaning their tumor burden was reduced, with four showing a complete response, or no detectable cancer.
The therapy was generally well tolerated, with no toxic effects to suggest the dose was too high, and none of the participants stopped treatment due to side effects. Cytokine release syndrome, an inflammatory reaction associated with many immune-modulating cancer therapies, was common, but was generally mild or moderate in severity. Mild injection site reactions were reported in half the patients and severe infections were reported in three. Most of those included in the preliminary data are continuing to receive ISB 2001 treatment.
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