生物抗体研发商Q32 Bio宣布FDA授予Bempikibart（ADX-914）快速通道资格，用于治疗斑秃-动脉网

Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata

CISION 等信源发布 2025-04-30 18:59

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WALTHAM, Mass.

马萨诸塞州沃尔瑟姆

，

April 30, 2025

2025年4月30日

/PRNewswire/ -- Q32 Bio Inc. (Nasdaq:

/PRNewswire/ -- Q32 Bio Inc.（纳斯达克：

QTTB

量子传输测试平台 (QTTB)

) ('Q32 Bio'), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (AA) and other autoimmune and inflammatory diseases, today announced that the United States Food and Drug Administration ('FDA') has granted Fast Track designation (FTD) to Q32 Bio's bempikibart (ADX-914) for the treatment of AA.

Q32 Bio是一家处于临床阶段的生物技术公司，专注于开发针对斑秃（AA）及其他自身免疫和炎症性疾病的创新疗法。该公司今日宣布，美国食品药品监督管理局（FDA）已授予Q32 Bio的bempikibart（ADX-914）用于治疗斑秃（AA）的快速通道资格（FTD）。

Bempikibart is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking IL-7 and TSLP signaling that is in development for the treatment of AA and currently being evaluated in a Phase 2 program..

Bempikibart 是一种全人源抗 IL-7Rα 抗体，通过阻断 IL-7 和 TSLP 信号重新调节适应性免疫功能，目前正在开发用于治疗 AA，并在 2 期项目中进行评估。

'The Fast Track designation granted by the FDA recognizes the seriousness of AA and the significant current unmet medical need while underscoring bempikibart's potential as a novel, differentiated therapy for patients needing new options,' said

“FDA授予的快速通道资格认可了AA的严重性以及当前显著未满足的医疗需求，同时强调了bempikibart作为针对需要新治疗选择患者的新型差异化疗法的潜力，”

Jodie Morrison

乔迪·莫里森

, Chief Executive Officer of Q32 Bio. 'This Fast Track designation follows the encouraging clinical activity observed in Part A of our SIGNAL-AA clinical trial and the recent initiation of dosing in the Part A open-label extension and Part B portions of the SIGNAL-AA trial. We look forward to continued collaboration with the FDA as we work to deliver this potentially paradigm-shifting treatment to patients.'.

Q32 Bio的首席执行官表示：“这一快速通道资格认定是基于我们的SIGNAL-AA临床试验A部分观察到的令人鼓舞的临床活性，以及最近在SIGNAL-AA试验的A部分开放标签扩展和B部分开始的给药。我们期待继续与FDA合作，努力将这种可能具有范式转变意义的治疗带给患者。”

Fast Track is a process designed to facilitate the development and expedite the review of new drugs to treat serious diseases and fill an unmet medical need with the purpose of getting important new drugs to patients earlier. Filling an unmet medical need is defined as providing a therapy where either none exists or providing a therapy which may be potentially better than available therapies.

快速通道是一个旨在促进用于治疗严重疾病、满足未满足医疗需求的新药开发并加快其审查过程的程序，目的是让重要的新药更早地提供给患者。满足未满足的医疗需求被定义为在无现有疗法或可能比现有疗法更好的情况下提供一种治疗手段。

A drug that receives FTD may be eligible for more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval and for a rolling review of an application for marketing approval. Drugs receiving FTD may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

获得快速通道资格（FTD）的药物可能有资格与FDA更频繁地召开会议和进行沟通，以讨论开发计划并确保收集到支持批准所需的数据，并可进行营销批准申请的滚动审查。若符合相关标准，获得FTD的药物还可能有资格获得加速批准和优先审查。

More information on the FDA's Fast Track process is available .

有关FDA快速通道流程的更多信息，请参见。

here

这里

。

About Q32 Bio

关于Q32生物公司

Q32 Bio is a clinical stage biotechnology company whose science targets potent regulators of the adaptive immune system to re-balance immunity and is focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases. About 700,000 people in

Q32 Bio是一家临床阶段的生物技术公司，其研究目标是针对适应性免疫系统的有效调节因子，以重新平衡免疫力，并专注于开发针对斑秃和其他自身免疫及炎症性疾病的创新疗法。约有70万人在...

the United States

美国

live with alopecia areata

与斑秃共存

, a disease which has a life-altering impact on patients and limited current treatment options. Q32 Bio is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function, for the treatment of alopecia areata in an ongoing Phase 2 program. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases..

，这种疾病对患者的生活影响深远，且目前的治疗选择有限。Q32 Bio正在推进bempikibart（ADX-914），一种全人源抗IL-7Rα抗体，用于在持续进行的二期项目中治疗斑秃，该抗体可重新调节适应性免疫功能。IL-7和TSLP通路在遗传学和生物学上已被证明参与驱动多种自身免疫疾病中的多个T细胞介导的病理过程。

For more information, visit

欲了解更多信息，请访问

www.Q32Bio.com

。

National Alopecia Areata Foundation

全国斑秃基金会

Availability of Other Information About Q32 Bio

关于Q32 Bio的其他信息的可用性

Investors and others should note that Q32 Bio communicates with its investors and the public using its website

投资者及其他人士应注意，Q32 Bio使用其网站与其投资者和公众进行沟通。

www.Q32Bio.com

, including, but not limited to, Q32 Bio's disclosures, investor presentations and FAQs, Securities and Exchange Commission (the 'SEC') filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that Q32 Bio posts on its website or on X or LinkedIn could be deemed to be material information.

，包括但不限于Q32 Bio的公告、投资者演示文稿和常见问题解答、证券交易委员会（“SEC”）文件、新闻稿、公开电话会议记录和网络广播记录，以及在X（前身为Twitter）和LinkedIn上的内容。Q32 Bio在其网站或X或LinkedIn上发布的信息可能被视为重要信息。

As a result, Q32 Bio encourages investors, the media and others interested to review the information that it posts there on a regular basis. The contents of Q32 Bio's website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended..

因此，Q32 Bio鼓励投资者、媒体及其他感兴趣的人士定期查阅其发布在网站上的信息。Q32 Bio的网站或社交媒体内容不应被视为依据修订后的《1933年证券法》进行的任何文件备案的引用内容。

Forward-Looking Statements

前瞻性声明

This communication contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, Q32 Bio's beliefs, observations, expectations and assumptions regarding the data reported to date from Part A of the SIGNAL-AA Phase 2a clinical trial, the plan, purpose and timing of Part B of the SIGNAL-AA Phase 2a clinical trial and the anticipated timing of its data, the safety, tolerability, clinical activity, potential efficacy and potential benefits of bempikibart, and the potential benefits conferred by Fast Track designation for bempikibart; which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements..

本通讯包含根据经修订的1995年美国私人证券诉讼改革法案及其他联邦证券法律所定义的前瞻性陈述。本文中包含的任何未描述历史事实的陈述，包括但不限于Q32 Bio对SIGNAL-AA 2a期临床试验A部分迄今为止报告数据的信念、观察、预期和假设，B部分的计划、目的和时间安排及预期的数据发布时间，bempikibart的安全性、耐受性、临床活性、潜在疗效和潜在益处，以及快速通道指定可能为bempikibart带来的潜在益处；这些陈述涉及可能导致实际结果与这些前瞻性陈述中讨论的结果有重大差异的风险和不确定性。

Forward-looking statements are based on management's current beliefs and assumptions, which are subject to risks and uncertainties and are not guarantees of future performance. Such risks and uncertainties include, among others, the risk that additional data, or the results of ongoing data analyses, may not support Q32 Bio's current beliefs and expectations for bempikibart, including with respect to the durability of clinical responses, safety profile, and the risk that ongoing and future clinical studies, including Part B of the SIGNAL-AA Phase 2a clinical trial may not be enrolled as quickly as expected or at all or might be more costly than expected or might not yield anticipated results, and that Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and such other risks and uncertainties identified in Q32 Bio's periodic, current and other filings with the SEC, including its Annual Report on Form 10-K for the year ended .

前瞻性声明基于管理层当前的信念和假设，这些信念和假设受风险和不确定性影响，并不保证未来的表现。这些风险和不确定性包括（但不限于）以下风险：额外数据或正在进行的数据分析可能无法支持Q32 Bio对bempikibart的当前信念和预期，包括关于临床反应持久性、安全性特征的风险；正在进行和未来的临床研究（包括SIGNAL-AA 2a期临床试验的B部分）可能无法按预期速度招募患者，或者可能成本高于预期，或者可能无法产生预期结果；FDA的快速通道指定可能实际上并不会导致更快的开发或监管审查及批准流程；以及Q32 Bio在向SEC提交的定期报告、当前报告及其他文件中确定的其他风险和不确定性，包括其年度报告表格10-K中截至某年的问题。

December 31, 2024

2024年12月31日

and any subsequent filings with the SEC, which are available at the SEC's website at

并向美国证券交易委员会提交的任何后续文件，这些文件可以在美国证券交易委员会的网站上找到，网址为

www.sec.gov

. Any such risks and uncertainties could materially and adversely affect Q32 Bio's results of operations and its cash flows, which would, in turn, have a significant and adverse impact on Q32 Bio's stock price. Q32 Bio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

任何此类风险和不确定性都可能对Q32 Bio的经营结果及其现金流量产生重大不利影响，这反过来将对Q32 Bio的股价产生显著的负面影响。Q32 Bio提醒您不要过分依赖任何前瞻性声明，这些声明仅在其作出之日有效。

Q32 Bio disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements..

Q32 Bio否认有任何义务公开更新或修改任何此类声明，以反映任何预期变化或事件、条件或情况的变化，这些声明可能是基于这些变化或可能影响实际结果与前瞻性声明中所述结果不同的可能性。

Contacts:

联系人：

Investors:

投资者：

Brendan Burns

布伦丹·伯恩斯

Argot Partners

行话伙伴

212.600.1902

Q32Bio@argotpartners.com

Media: