IGI, Inc., a global, fully integrated clinical-stage biotechnology company focused on developing multispecifics™ in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ISB 2001. This important designation was granted for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

IGI公司是一家全球性的、完全整合的临床阶段生物技术公司，专注于开发多特异性™肿瘤学疗法，今天宣布美国食品药品监督管理局（FDA）已授予ISB 2001快速通道资格。这一重要资格是针对治疗复发或难治性多发性骨髓瘤（RRMM）成人患者的，这些患者已经接受过至少三线治疗，包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体。

ISB 2001 is an investigational trispecific antibody therapeutic that targets BCMA and CD38 on myeloma cells and CD3 on T cells. ISB 2001 is currently being evaluated in a Phase 1 dose-expansion study..

ISB 2001 是一种研究性三特异性抗体疗法，靶向骨髓瘤细胞上的 BCMA 和 CD38 以及 T 细胞上的 CD3。ISB 2001 目前正在一项 1 期剂量扩展研究中进行评估。

“A growing 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., President and CEO of IGI. “At IGI, we have long recognized the urgent need for novel treatment options – particularly for patients who have already received first-generation bispecifics or CAR T-cell therapies.

“越来越多的多发性骨髓瘤患者已经接受了大量预处理，耗尽了目前获批的疗法，仍然面临疾病进展，”IGI 总裁兼首席执行官 Cyril Konto 医学博士表示。“在 IGI，我们早已认识到对新型治疗方案的迫切需求——尤其是对于那些已经接受过第一代双特异性抗体或 CAR-T 细胞疗法的患者。”

Our trispecific candidate is designed to enhance tumor targeting while reducing on-target, off-tumor toxicity. We are honored to receive this Fast Track designation and look forward to working closely with the FDA to advance our Multispecific™ T-cell engager, with the goal of delivering a first-in-class therapy for patients with relapsed or refractory multiple myeloma.”.

我们的三特异性候选药物旨在增强肿瘤靶向性，同时减少靶向肿瘤外的毒性。我们很荣幸获得这一快速通道资格，并期待与FDA密切合作，推进我们的Multispecific™ T细胞接合器，目标是为复发或难治性多发性骨髓瘤患者提供一种首创的治疗方法。"

IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma. Initial study results, 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.

IGI最近完成了其在多线治疗后的多发性骨髓瘤患者中进行的1期临床试验的剂量递增部分。初步研究结果在2024年12月的美国血液学会（ASH）年会上以口头报告形式展示，显示出较高的总体缓解率（ORR）、持久的疗效以及良好的安全性。

Complete results from the dose-escalation portion will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025..

剂量递增部分的完整结果将在2025年6月2日（星期一）举行的2025年美国临床肿瘤学会（ASCO）年会上以快速口头报告的形式呈现。

The FDA’s Fast Track designation is designed to enable the development and expedite the review of drugs that treat serious conditions and address unmet medical needs, with the ultimate goal of getting important new drugs to patients earlier. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

FDA的快速通道资格旨在促进用于治疗严重疾病并满足未竟医疗需求的药物的研发，并加速其审评过程，最终目标是让患者更早获得重要的新药。获得快速通道资格的药物可能有资格与FDA进行更频繁的会议和沟通，并对其任何上市申请进行滚动审评。

A drug receiving Fast Track designation also may be eligible for Priority Review if relevant criteria are met. ISB 2001 was previously granted Orphan Drug Designation by the FDA in July 2023..

获得快速通道指定的药物如果符合相关标准，也可能有资格获得优先审查。ISB 2001曾在2023年7月获得FDA的孤儿药指定。

ASCO Rapid Oral Presentation Details:

ASCO快速口头报告详情：

Session title: Phase 1, first-in-human study of ISB 2001: A BCMAxCD38xCD3-targeting trispecific antibody for patients with relapsed/refractory multiple myeloma (RRMM)—Dose escalation results. (Abstract # 7514)

会议标题：ISB 2001一期首次人体研究：一种针对复发/难治性多发性骨髓瘤（RRMM）患者的BCMAxCD38xCD3三特异性抗体——剂量递增结果。（摘要编号 #7514）

Session Name: Hematologic Malignancies—Plasma Cell Dyscrasia

会议名称：血液系统恶性肿瘤——浆细胞异常增生症

Date & Time: June 2, 2025, 8 AM – 9:30 AM CDT

日期和时间：2025年6月2日，上午8点 – 上午9点30分（中部夏令时）

About ISB 2001 and Relapsed/Refractory Multiple Myeloma

关于ISB 2001和复发/难治性多发性骨髓瘤

ISB 2001 is a first-in-class trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells. Developed using IGI’s proprietary BEAT® protein platform, ISB 2001 was engineered with two distinct binders against myeloma-associated antigens to enhance avidity, even at low target expression levels, while aiming to improve safety over first-generation bispecific antibodies.

ISB 2001 是一种首创的三特异性 T 细胞接合器，靶向骨髓瘤细胞上的 BCMA 和 CD38 以及 T 细胞上的 CD3。该药物利用 IGI 专有的 BEAT® 蛋白质平台开发，通过设计针对骨髓瘤相关抗原的两种不同结合剂来增强亲和力，即使在靶标表达水平较低的情况下亦是如此，同时旨在提升相对于第一代双特异性抗体的安全性。

The dose-expansion portion of the ongoing Phase 1 trial in patients with RRMM (NCT05862012) is currently enrolling patients across 9 sites in the United States and Australia..

正在进行的针对复发难治性多发性骨髓瘤（RRMM）患者的1期试验（NCT05862012）的剂量扩展部分目前正在美国和澳大利亚的9个试验点招募患者。

Nearly all patients with relapsed or refractory multiple myeloma (RRMM) ultimately experience disease progression. With no cure currently available and limited treatment options once approved therapies are exhausted, there remains a significant unmet need. IGI is developing ISB 2001 to address this gap, specifically for patients who have previously received T-cell–directed therapies, including CAR T-cell treatments and bispecific antibodies..

几乎所有复发或难治性多发性骨髓瘤（RRMM）患者最终都会出现疾病进展。由于目前尚无治愈方法，且一旦现有疗法失效后治疗选择有限，因此仍存在显著的未满足需求。IGI公司正在开发ISB 2001以填补这一空白，特别是针对那些先前接受过T细胞导向疗法（包括CAR-T细胞治疗和双特异性抗体）的患者。

About IGI, Inc.

关于IGI公司

IGI, Inc. is a global, fully integrated clinical-stage biotechnology company focused on developing innovative biologics in oncology. Headquartered in New York, NY, IGI is advancing a robust pipeline of novel, first-in-class multispecifics™ aimed at addressing complex diseases and treating patients holistically.

IGI公司是一家全球性、完全整合的临床阶段生物技术公司，专注于开发肿瘤学领域的创新生物制品。总部位于纽约州纽约市，IGI正在推进一系列强大且新颖的首创多特异性药物™的研发管线，旨在应对复杂疾病并全面治疗患者。

Powered by its proprietary BEAT technology platform, IGI is committed to delivering breakthrough, curative therapies to improve and extend the lives of patients battling hematological malignancies and solid tumors. For more information, visit www.IGInnovate.com..

依托其专有的BEAT技术平台，IGI致力于提供突破性的治愈疗法，以改善和延长正在与血液恶性肿瘤和实体瘤抗争的患者的生命。欲了解更多信息，请访问www.IGInnovate.com。

For more information, please contact:

如需更多信息，请联系：

[media]

[媒体]

Lisa Guiterman

丽莎·古特曼

Cell: 202-330-3431

电话：202-330-3431

lisa.guiterman@gmail.com

丽莎·吉特曼@gmail.com

IGI Corporate Communications Team

IGI企业传播团队

Corporate.communications@iginnovate.com

Corporate.communications@iginnovate.com

Source: globenewswire.com

来源：globenewswire.com