FDA Issues Fast Track Designation to First-In-Class Trispecific Antibody for Refractory Multiple Myeloma

The FDA has granted Fast Track Designation to ISB 2001 from Ichnos Glenmark Innovation (IGI) to treat relapsed or refractory multiple myeloma (MM). This designation is specifically for adult patients who have undergone at least three prior lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulatory agent, and a proteasome inhibitor. ISB 2001 has had Orphan Drug Designation from the FDA since July 2023, and this newly received designation was announced by IGI in a press release.

ISB 2001 is a first-in-class, T-cell-engaging trispecific antibody that targets BCMA and CD38 on myeloma cells and CD3 on T cells. IGI developed this agent with its proprietary BEAT protein platform to be a treatment option for patients with MM that has progressed despite several interventions, while also having better safety than first-generation bispecifics.

“At IGI, we have long recognized the urgent need for novel treatment options, particularly for patients who have already received first-generation bispecifics or CAR T-cell therapies. Our trispecific candidate is designed to enhance tumor targeting while reducing on-target, off-tumor toxicity,” wrote IGI president and chief executive officer Cyril Konto, MD.

An ongoing phase 1, first-in-human clinical trial evaluates ISB 2001 in patients with heavily-pretreated MM. In initial results with this agent, presented at the American Society of Hematology Annual Meeting in December 2024, showed a high overall response rate, durable responses, and favorable safety. Findings from the trial’s dose-escalation portion will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in June, and enrollment of patients for the dose-expansion portion of the trial is currently underway in Australia and the US.

Reference

Ichnos Glenmark Innovation. Accessed May 6, 2025. https://iginnovate.com/2025/05/03/ichnos-glenmark-innovation-igi-receives-usfda-fasttrack-designation-for-isb-2001-for-relapsed-refractory-multiple-myeloma/