#USA #New York #Multiple Myeloma #Ichnos Glenmark #ISB 2001

Ichnos Glenmark Innovation (IGI) and the FDA Fast-Track Designation

In a significant breakthrough for cancer treatment, Ichnos Glenmark Innovation (IGI), a global biotechnology firm specializing in oncology, has announced that the U.S. Food and Drug Administration (FDA) granted Fast-Track designation for ISB 2001. This treatment is aimed at adult patients suffering from relapsed or refractory multiple myeloma (RRMM), particularly those who have already undergone at least three prior therapies, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies.

The Promise of ISB 2001

ISB 2001 is a cutting-edge trispecific antibody therapeutic that targets cancer cells exhibiting BCMA and CD38, as well as CD3 on T-cells. Currently, IGI is conducting a Phase 1 dose-expansion study to evaluate the efficacy and safety of ISB 2001 in treating patients with RRMM.

Dr. Cyril Konto, IGI’s President and CEO, expressed the urgency behind this development, highlighting the growing population of patients with multiple myeloma who have been heavily pre-treated and see limited options for further therapy. “At IGI, we recognize the pressing need for new treatment alternatives, especially for patients who have already received first-generation bispecific antibodies or CAR-T cell therapies,” he stated. The trispecific candidate aims to enhance tumor efficacy while reducing on-target toxicity outside the tumor.

Clinical Trials and Future Steps

Recently, IGI completed the dose-escalation portion of its clinical Phase 1 study among patients with heavily pretreated multiple myeloma. The preliminary results, presented at the American Society of Hematology (ASH) annual meeting in December 2024, revealed a high overall response rate (ORR) with sustained responses and a favorable safety profile. Complete results from the dose-escalation phase will be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting scheduled for June 2, 2025.

The FDA Fast-Track designation is designed to expedite the development and review of drugs intended for serious conditions that address unmet medical needs, facilitating quicker patient access to critical new therapies. Drugs granted Fast-Track status are eligible for more frequent meetings and communications with the FDA, as well as rolling review of the application. Such a designation can also qualify a drug for priority review status when applicable criteria are met.

Additionally, ISB 2001 was earlier designated as an orphan drug by the FDA in July 2023, underscoring its potential significance in addressing rare diseases.

Upcoming ASCO Presentation

Details regarding the ASCO presentation include a session titled "Phase 1, First-in-Human Study of ISB 2001 – A BCMAxCD38xCD3-specific Trispecific Antibody for Patients with RRMM". This session will provide crucial insights into the outcomes of the dose-escalation study.

Session Details

• - Date and Time: June 2, 2025, from 8:00 AM to 9:30 AM CDT
• - Session Title: Hematologic Malignancies - Plasma Cell Dyscrasia

Conclusion

ISB 2001, built on IGI’s proprietary BEAT® technology platform, aims to bridge the treatment gap for patients with RRMM, particularly for those who have previously received T-cell-targeted therapies like CAR-T treatments and bispecific antibodies. As the clinical trial progresses, IGI maintains its commitment to developing groundbreaking therapies to improve and extend the lives of patients battling hematological malignancies and solid tumors. For more details about IGI, visit www.IGInnovate.com.