IGI, a global, fully integrated, clinical-stage biotechnology company focused on multi-species™ oncology product development,  announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ISB 2001. This important designation has been granted for the treatment of adult patients with relapsed or refractory multiple myeloma (MMR) who have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ISB 2001 is an investigational trispecific therapeutic antibody that targets BCMA and CD38 on myeloma cells and CD3 on T cells. ISB 2001 is currently in a Phase 1 dose expansion study.

"An increasing number of patients with multiple myeloma have been heavily pretreated, have exhausted currently approved therapies, and continue to face disease progression," said Cyril Konto, M.D., IGI's president, executive director and CEO. "At IGI, we have long recognized the urgent need for new treatment options – especially for patients who have previously received first-generation bispecific therapies or CAR T-cell therapies. Our trispecific candidate is designed to improve tumor targeting while reducing toxicity on and off the target. We are honored to receive this Fast Track designation and look forward to working closely with the FDA to advance our Multispecific™ T-cell engagement agent, with the goal of providing a best-in-class therapy for patients with relapsed or refractory multiple myeloma." »

IGI recently completed the dose-escalation phase of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma. Initial results from the study, presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated a high overall response rate (ORR) with durable responses and a favorable safety profile. The full results of the dose-escalation phase will be presented in a rapid oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025.

The FDA's Fast Track designation is designed to enable the development and expedite review of drugs that treat serious conditions and address unmet medical needs, with the ultimate goal of bringing important new drugs to patients faster. A drug with Fast Track designation may benefit from more frequent meetings and communications with the FDA and expedited review of any marketing authorization application. A medicinal product benefiting from the accelerated procedure may also be eligible for the priority review procedure if the relevant criteria are met. ISB 2001 was previously granted orphan drug designation by the FDA in July 2023.