Ingenium Therapeutics收到FDA反馈，允许Gengleucel在MRD+ AML中直接进行二期试验-动脉网

Ingenium Therapeutics Receives FDA Feedback Enabling Direct Phase 2 Trial for Gengleucel in MRD+ AML

CISION 等信源发布 2025-04-30 20:33

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SEOUL, South Korea

韩国首尔

，

April 30, 2025

2025年4月30日

/PRNewswire/ --

/美通社/ --

Ingenium Therapeutics

天才制药公司

, a clinical-stage biotechnology company advancing allogeneic natural killer (NK) cell therapies, today announced that it has received positive regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Pre-Investigational New Drug (Pre-IND) meeting.

一家临床阶段的生物技术公司，正在推进同种异体自然杀伤（NK）细胞疗法，今天宣布在与美国食品药品监督管理局（FDA）进行新药临床试验前（Pre-IND）会议后，获得了积极的监管反馈。

Ingenium has conducted multiple investigator-initiated trials in

Ingenium已经开展了多次研究者发起的试验

South Korea

韩国

, enrolling over 140 patients with acute myeloid leukemia (AML), including a Phase 2 randomized clinical trial with long-term overall survival follow-up. These studies have generated robust non-clinical and clinical data supporting the safety and efficacy profile of Gengleucel.

，共纳入了140多名急性髓系白血病（AML）患者，包括一项二期随机临床试验，并进行了长期总生存期随访。这些研究已经产生了强有力的支持Gengleucel安全性和有效性特征的非临床和临床数据。

Based on its review of these data, the FDA has provided positive feedback on Ingenium's proposal to initiate a Phase 2 trial of Gengleucel in

基于对这些数据的审查，FDA对Ingenium启动Gengleucel二期试验的提案给予了积极反馈。

the United States

美国

without a preceding Phase 1 study. This regulatory milestone may streamline Gengleucel's clinical development pathway and may accelerate access for patients with measurable residual disease-positive (MRD+) AML.

无需进行前期的1期研究。这一监管里程碑可能会简化Gengleucel的临床开发路径，并可能加速可测量残留病灶阳性（MRD+）急性髓系白血病（AML）患者的获取。

The planned multicenter study will be conducted at leading cancer centers across

计划中的多中心研究将在领先的癌症中心进行

the United States

美国

, including a world-renowned institution in

，包括一个世界知名的机构在

Texas

德克萨斯州

. Gengleucel is positioned to become the first NK cell therapy in AML to use MRD negativity as a primary endpoint, underscoring its potential to improve outcomes by eradicating minimal residual disease and reducing relapse risk.

Gengleucel有望成为首个在急性髓系白血病（AML）中使用微小残留病（MRD）阴性作为主要终点的NK细胞疗法，凸显了其通过清除微小残留病和降低复发风险来改善预后的潜力。

'We are thrilled with the FDA's guidance, which reflects the rigor of our clinical research and the significant therapeutic potential of Gengleucel, especially in targeting minimal residual disease,' said

“我们对FDA的指导感到非常兴奋，这反映了我们临床研究的严谨性以及Gengleucel的巨大治疗潜力，特别是在针对微小残留病方面，”

Kevin Koh

高文杰

, CEO of Ingenium Therapeutics. 'Launching our U.S. Phase 2 trial at premier cancer centers marks a major milestone in our mission to deliver novel immunotherapies to AML patients with MRD.'

Ingenium Therapeutics首席执行官表示：“在顶级癌症中心启动我们美国的二期临床试验，标志着我们为MRD阳性的AML患者提供新型免疫疗法的使命迈出了重要的一步。”

The trial is expected to begin in early 2026 and will evaluate Gengleucel's ability to achieve MRD negativity and reduce relapse and mortality. To ensure reliable clinical operations and product supply, Ingenium is transferring its manufacturing technology to a

试验预计将于2026年初开始，将评估Gengleucel实现MRD阴性以及减少复发和死亡的能力。为确保可靠的临床操作和产品供应，Ingenium公司正在将其制造技术转移至

Texas

德克萨斯州

-based manufacturing facility.

-基于的制造设施。

About Gengleucel

关于Gengleucel

Gengleucel is a non-engineered, allogeneic NK cell therapy composed of memory NK cells with enhanced activating receptor expression and increased secretion of IFN-gamma, granzyme, and perforin. These features drive potent anti-cancer activity and sustained in vivo persistence. Clinical trials have demonstrated Gengleucel's favorable safety, tolerability, and efficacy in high-risk AML and MDS populations.

Gengleucel是一种非工程化的同种异体NK细胞疗法，由记忆NK细胞组成，这些细胞具有增强的激活受体表达以及增加的IFN-γ、颗粒酶和穿孔素分泌。这些特性推动了强大的抗癌活性和持续的体内存留。临床试验已证明，Gengleucel在高风险AML和MDS人群中具有良好的安全性、耐受性和有效性。

Gengleucel has been granted Orphan Drug Designation by the U.S. FDA for the treatment of AML..

Gengleucel 已被美国 FDA 授予治疗急性髓系白血病（AML）的孤儿药资格。

About Ingenium Therapeutics

关于Ingenium治疗学

Ingenium Therapeutics is a clinical-stage biotechnology company focused on advancing off-the-shelf NK cell therapies for hematologic malignancies and pioneering novel in vivo 5th generation CAR-NK therapies for solid tumors. By harnessing deep clinical expertise, a cutting-edge cell therapy platform, and robust global partnerships, Ingenium is committed to developing transformative, precise, and durable immunotherapies for patients worldwide..

Ingenium Therapeutics是一家临床阶段的生物技术公司，专注于推进用于血液恶性肿瘤的现成NK细胞疗法，并开创用于实体瘤的新型体内第五代CAR-NK疗法。通过利用深厚的临床专业知识、尖端的细胞治疗平台以及强大的全球合作伙伴关系，Ingenium致力于为全球患者开发变革性、精准且持久的免疫疗法。

Contact:

联系人：

Martin Hyun

马丁·玄

394304@email4pr.com

808-354-9669

SOURCE Ingenium Therapeutics

来源：Ingenium治疗公司

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