IGI’s ISB‍ 2001 receives FDA Fast Track for Multiple Myeloma Treatment

NEW YORK, May 6, 2025 – IGI, a⁢ global biotechnology company focused on ‍developing multispecific antibodies for cancer treatment, announced that the U.S. Food and Drug Governance (FDA) has granted Fast Track designation⁣ to ISB 2001.The designation ⁢aims to ⁣expedite the⁢ development and review of ISB 2001 for adult‍ patients with relapsed or refractory multiple myeloma (RRMM) who have ⁣received at ⁣least three prior therapies, including an⁤ immunomodulatory agent and ⁣a‍ monoclonal anti-CD38 antibody.

ISB 2001 is ⁤a trispecific antibody therapy targeting BCMA and CD38 on myeloma cells,‍ and CD3 on T cells.The drug is currently under evaluation ⁣in a Phase 1 dose escalation study.

“A growing number of multiple myeloma patients have been heavily pretreated and have exhausted currently approved therapies, facing disease progression,” said a representative for IGI.“IGI recognizes the urgent ⁣need for new treatment options, especially for patients who have received bispecific antibodies or CAR-T⁢ cell therapies. Our trispecific candidate aims to strengthen the effect on the tumor. We look forward to working closely with the FDA to further develop our MultiSPECIFIC™ TELL-GOME, with⁢ the goal of providing first-in-class therapy⁣ for patients with relapsed or‍ refractory multiple myeloma.”

Phase 1⁢ Study Results

IGI ⁣recently concluded the dose escalation phase of its Phase 1 clinical trial of ISB 2001 in heavily pretreated multiple myeloma patients. Initial findings, presented at the ⁢American Society of Hematology ⁣(ASH) annual meeting in December 2024, demonstrated a high overall response rate (ORR) with durable responses and a⁣ manageable safety profile. Thorough results from the dose escalation portion will be presented in an oral presentation ⁣at the American Society of clinical‍ Oncology (ASCO) annual meeting on⁣ Monday, June 2, 2025.

FDA Fast⁢ Track Designation

The FDA’s Fast Track program is designed to accelerate the development⁣ and review of drugs intended to treat serious conditions and address unmet ‍medical needs. Drugs receiving Fast Track designation might potentially be eligible ‍for more frequent meetings and communication with the FDA, as ⁤well as rolling review ⁤of the marketing application. Fast Track status can also lead to priority review if applicable criteria are met. ISB 2001 received Orphan Drug designation from ‍the FDA in July 2023.

ASCO presentation Details

• Session Title: Phase 1 First-in-Human Study ⁢of ISB 2001: A BCMAxCD38xCD3 ⁣Trispecific Antibody for Patients with Relapsed/Refractory Multiple myeloma (RRMM)⁤ – Results of Dose Escalation (Abstract #7514)
• Session Name: Hematologic Malignancies – Plasma Cell ‍Dyscrasia
• Date and Time: June 2, 2025, 8:00 a.m.⁢ – 9:30 a.m. CDT

About ISB 2001

ISB 2001 is a⁤ trispecific T-cell engager designed to target⁢ BCMA ‍and CD38 on⁢ myeloma cells and CD3 on T⁣ cells. ISB 2001 is based on IGI’s BEAT^® protein platform and incorporates two distinct binders against myeloma-associated antigens to enhance avidity, even at low⁤ target expression levels, ⁤while also improving safety compared to first-generation therapies. The ongoing Phase⁣ 1 dose escalation study⁤ in RRMM patients (NCT05862012) is currently enrolling participants at multiple sites in the United States‍ and Australia.

About Relapsed/Refractory Multiple Myeloma

Nearly all patients with relapsed or⁣ refractory multiple myeloma (RRMM)‍ experience disease progression. With no current cure and limited treatment options following the failure of approved therapies,⁤ a notable unmet need remains. IGI is⁤ developing ‍ISB 2001 to address this gap, especially‍ for patients who have previously ⁤received T-cell-directed therapies, including CAR-T cell treatments and bispecific ⁤antibodies.

About IGI

IGI is a global, fully integrated biotechnology company in the clinical stage focused on developing innovative biologics in oncology. Headquartered⁤ in New York, ‍NY, IGI is developing a pipeline of novel, first-in-class MultiSPECIFICs™ designed to treat complex diseases and provide holistic patient care. Driven by its BEAT^® technology platform, IGI is committed to developing pioneering, curative therapies to improve and extend the lives of patients battling hematological malignancies and solid tumors. More information can be found at www.IGInnovate.com.