Glenmark's novel cancer drug gets fast track status from USFDA

Glenmark

Ichnos Glenmark Innovation (IGI), the R&D unit of Glenmark announced Monday it received Fast Track designation from the U.S. Food and Drug Administration (USFDA) for its experimental multiple myeloma therapy, ISB 2001. The designation targets the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously undergone at least three treatment regimens, including specific inhibitors and antibodies.

ISB 2001 is an investigational tri-specific antibody, a newer class of drug designed to engage the patient's T cells while simultaneously targeting two proteins found on myeloma cells: BCMA and CD38. This approach aims to enhance the drug's ability to find and bind to cancer cells, potentially offering a safety advantage over earlier bispecific antibody treatments. The therapy was developed using IGI's proprietary BEAT® technology platform.

The Fast Track status is intended to accelerate the development and review process for drugs addressing serious conditions with unmet medical needs, potentially bringing treatments to patients faster. It allows for more frequent interactions with the USFDA and eligibility for rolling reviews and Priority Review if criteria are met. This follows an Orphan Drug Designation granted by the USFDA for ISB 2001 in July 2023.

"A growing number of patients with multiple myeloma have been heavily pre-treated, have exhausted currently approved therapies, and continue to face disease progression," stated Cyril Konto, M.D., President and CEO of IGI. He highlighted the need for novel options, especially for those whose disease has progressed after receiving first-generation bispecific or CAR T-cell therapies.

IGI recently finished the dose-escalation part of its Phase 1 trial for ISB 2001, which is currently enrolling for its dose-expansion phase across sites in the U.S. and Australia. Preliminary results presented last December indicated a high overall response rate and a favorable safety profile. Updated, complete results are scheduled for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025.

Multiple myeloma remains largely incurable, with many patients eventually running out of effective treatment options. IGI aims for ISB 2001 to address this gap, particularly following T-cell directed therapies.

IGI, a clinical-stage biotech focused on oncology multispecifics, is headquartered in New York