Ichnos Glenmark Innovation Secures FDA Fast-Track Approval for ISB 2001 in Treating Relapsed Refractory Multiple Myeloma

New York - Ichnos Glenmark Innovation (IGI) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast-Track designation for its investigational drug ISB 2001. This approval is aimed at treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have undergone at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and a monoclonal anti-CD38 antibody.

ISB 2001 is a trispecific antibody therapeutic designed to target BCMA and CD38 on myeloma cells as well as CD3 on T-cells. This innovative treatment is currently being evaluated in a Phase 1 dose-expansion study.

According to Dr. Cyril Konto, the CEO of IGI, there is a pressing need for new treatment options for patients suffering from multiple myeloma, especially those who have exhausted all currently approved therapies and continue to face disease progression. The trispecific candidate aims to enhance tumor targeting while minimizing on-target toxicity outside the tumor environment. The Fast-Track approval is seen as a significant milestone, allowing IGI to collaborate closely with the FDA to further develop this promising therapeutic solution for patients with RRMM.

Recently, IGI completed the dose-escalation phase of its clinical trial involving heavily pretreated multiple myeloma patients. Preliminary results, which will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025, indicated a high overall response rate (ORR) with sustained responses and a favorable safety profile.

The FDA's Fast-Track designation is intended to facilitate the development and expedited review of drugs targeting serious conditions that fulfill unmet medical needs. Drugs that receive this status may be eligible for more frequent meetings and communications with the FDA, as well as a rolling review of the marketing application. ISB 2001 was previously designated as an orphan drug by the FDA in July 2023.

Details of the ASCO presentation include:

• Session Title: Phase 1, First-in-Human Study of ISB 2001: A BCMAxCD38xCD3-Specific Trispecific Antibody for Patients with Relapsed/Refractory Multiple Myeloma - Dose Escalation Results (Abstract #7514)
• Session Name: Hematologic Malignancies - Plasma Cell Dyscrasias
• Date and Time: June 2, 2025, 8:00 - 9:30 AM CDT

ISB 2001 operates as an advanced trispecific T-cell engager targeting BCMA and CD38 on myeloma cells and CD3 on T-cells. Developed using IGI's proprietary BEAT® protein platform, ISB 2001 features two distinct binders against myeloma-associated antigens, enhancing avidity at low target expression levels while improving safety compared to first-generation bispecific antibodies. The ongoing Phase-1 study's dose escalation phase is currently recruiting patients at nine sites across the United States and Australia.

Nearly all patients with RRMM ultimately experience disease progression. With no current cure and limited treatment options after available therapies are exhausted, the need for effective solutions remains critical. IGI is dedicated to addressing this gap with ISB 2001, particularly for patients previously treated with T-cell directed therapies, including CAR-T treatments and bispecific antibodies.

IGI is a fully integrated, clinical-stage biotechnology company headquartered in New York, focused on the development of innovative biologics in oncology. The company aims to advance a robust pipeline of novel, best-in-class multispecifics(TM) targeting complex diseases and holistic patient care. Driven by its proprietary BEAT technology platform, IGI is committed to developing groundbreaking, curative therapies to improve and extend the lives of patients battling hematologic malignancies and solid tumors. For more information, visit www.IGInnovate.com.