U.S. FDA Fast Tracks IGI's ISB 2001 for Relapsed Multiple Myeloma

In a significant development in cancer treatment, IGI, an innovative biotechnology company dedicated to oncology, has announced that its investigational drug, ISB 2001, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation is for ISB 2001's potential use in treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have already undergone at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

ISB 2001 is a pioneering trispecific antibody therapeutic that targets BCMA and CD38 on myeloma cells and CD3 on T cells. The drug is currently in a Phase 1 dose-expansion study. With many patients who have heavily pretreated multiple myeloma facing limited treatment options and continued disease progression, there is an urgent need for new therapeutic approaches. Cyril Konto, M.D., President and CEO of IGI, highlighted the importance of creating novel treatments for patients who have already tried existing therapies, including CAR T-cell therapies and first-generation bispecifics. Konto expressed enthusiasm about working collaboratively with the FDA to advance ISB 2001, with the aim of introducing a groundbreaking therapy for individuals with relapsed or refractory multiple myeloma.

The initial dose-escalation phase of IGI's Phase 1 clinical trial was recently completed, focusing on patients with heavily pretreated multiple myeloma. Preliminary findings, shared during an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, revealed a high overall response rate (ORR) along with sustained responses and a promising safety profile. The complete results from this phase are set to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025.

The FDA's Fast Track designation is intended to facilitate the development and accelerate the review of drugs that address serious health conditions and unmet medical needs. This status allows for more frequent interactions with the FDA and the possibility of a rolling review process for marketing approval. If certain criteria are met, drugs with this designation may also qualify for Priority Review. ISB 2001 had previously been granted Orphan Drug Designation by the FDA in July 2023.

ISB 2001 operates as a trispecific T-cell engager, interacting with BCMA and CD38 on myeloma cells while engaging CD3 on T cells. This drug was developed using IGI's proprietary BEAT® protein platform and is engineered to improve target binding and safety compared to earlier bispecific antibodies. The ongoing Phase 1 trial's dose-expansion segment is currently recruiting participants at various sites in the United States and Australia.

Relapsed or refractory multiple myeloma (RRMM) is a challenging condition, as most patients experience disease progression after exhausting available treatments. Given the absence of a cure and limited options after approved therapies have been tried, there is a significant need for new solutions. IGI is actively developing ISB 2001 to fill this gap, particularly for patients who have previously been treated with T-cell–directed therapies, including CAR T-cell treatments and bispecific antibodies.

IGI is a globally active clinical-stage biotechnology firm dedicated to advancing novel biologics in oncology. Headquartered in New York, IGI is focused on a pipeline of innovative multispecifics™ designed to tackle complex diseases comprehensively. Through its proprietary BEAT technology platform, IGI is committed to delivering transformative, curative treatments aimed at improving and extending the lives of patients with hematological cancers and solid tumors.