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

Ichnos Glenmark Innovation's Major Milestone with ISB 2001

In a significant advancement for cancer treatment, Ichnos Glenmark Innovation (IGI) has announced that its investigational therapy, ISB 2001, has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA). This designation pertains to the treatment of adult patients suffering from relapsed or refractory multiple myeloma, a condition where the disease recurs after previous treatments.

IGI specializes in biotechnology, focusing on multi-specific products aimed at oncology. The Fast Track status is crucial, as it is intended for medications that address severe conditions and fit the criteria of meeting significant unmet medical needs. ISB 2001 is an experimental trispecific antibody that targets BCMA and CD38 on myeloma cells as well as CD3 on T cells, marking a novel approach in the therapeutic landscape.

Dr. Cyril Konto, the president and CEO of IGI, expressed the urgent need for new treatment options due to the increasing number of patients who have been heavily pre-treated and subsequently exhausted current approved therapies. He emphasized, "Our trispecific candidate is designed to enhance tumor targeting while minimizing toxicity, which is especially critical for patients who have already undergone first-generation bispecific therapies or CAR T-cell therapies."

Currently, ISB 2001 is undergoing a Phase 1 dose expansion study, with early results indicating a promising overall response rate along with durable responses and a favorable safety profile. These early findings were shared during a presentation at the American Society of Hematology (ASH) Annual Meeting, further establishing the potential of ISB 2001 as a leading-edge therapy.

The upcoming presentation of complete results at the American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for June 2nd, 2025, will illuminate further insights into the therapy's efficacy. The Fast Track designation not only allows for expedited development and review of ISB 2001 but also provides opportunities for more frequent meetings and communications with the FDA, facilitating a faster path towards bringing this important therapy to market.

Fast Track designation is especially beneficial for drugs that offer significant advantages over existing treatments and can lead to Priority Review status if certain criteria are met. Already dubbed an orphan drug by the FDA in July 2023, ISB 2001 embodies the hope for those facing the progressive challenges of relapsed or refractory multiple myeloma.

The unmet medical needs in this field are vast, as nearly all patients with this condition eventually experience disease progression and treatment options dwindle post-therapy. Thus, IGI's focus on developing ISB 2001 aims to bridge this gap, particularly for patients who have already experienced numerous therapies, including CAR T-cell and bispecific antibodies.

About ISB 2001 and Multiple Myeloma

ISB 2001 is unique as a first-in-class trispecific antibody. Developed using IGI's proprietary BEAT® protein platform, it boasts two distinct binders against the myeloma-associated antigens, designed to enhance binding affinity even at low levels of target expression while improving safety compared to first-generation bispecific antibodies. The ongoing clinical trial (NCT05862012) is actively recruiting patients across nine sites in the United States and Australia, paving the way for further developments.

IGI's ambitious goal is to create transformative therapies that can significantly improve outcomes for patients dealing with hematological malignancies and solid tumors. This dedication stems from a commitment to innovation and improving the quality of life for cancer patients. For further updates about IGI and its pipeline of groundbreaking therapies, visit www.IGInnovate.com.

As we await the detailed findings from ASCO, the medical community remains hopeful that ISB 2001 may represent a new dawn for multiple myeloma treatment, underscoring the critical need for innovative and effective therapies in this challenging field.