First Characterization of a TDP-43 PET Tracer Published in

首次发布TDP-43 PET示踪剂的特性描述

Nature Communications

自然通讯

Showing Potential of AC Immune’s ACI-19626 in Precision Medicine

展示AC Immune的ACI-19626在精准医学中的潜力

Lausanne,

洛桑，

Switzerland

瑞士

,

，

October 24, 2025

2025年10月24日

--

--

AC Immune SA

AC Immune SA

(NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced the publication in

(NASDAQ: ACIU)，一家处于临床阶段的生物制药公司，致力于为神经退行性疾病开发精准疗法，今天宣布在以下刊物中发表

Nature Communications

自然通讯

of preclinical data on its first-in-class brain positron emission tomography (PET) tracers for imaging TDP-43 pathology. The selected candidate, ACI-19626, potentially enables a precision medicine approach to multiple neurodegenerative diseases that are currently difficult to diagnose and differentiate from each other..

其首创新型大脑正电子发射断层扫描（PET）示踪剂用于成像TDP-43病理的临床前数据。所选候选物ACI-19626可能为目前难以诊断和相互区分的多种神经退行性疾病提供一种精准医学方法。

TDP-43 is the main component in inclusions found in the brains of people with amyotrophic lateral sclerosis (ALS), frontotemporal degeneration (FTD) and limbic-predominant age-related TDP-43 encephalopathy (LATE), as well as a co-pathology in Alzheimer’s disease (AD) and Parkinson’s disease (PD). These conditions share many of the same clinical signs and symptoms, making differential diagnosis a difficult and lengthy process in the absence of reliable biomarkers.

TDP-43 是肌萎缩侧索硬化症 (ALS)、额颞叶退化 (FTD)、边缘主导的年龄相关性 TDP-43 脑病 (LATE) 患者大脑中发现的包涵体的主要成分，同时也是阿尔茨海默病 (AD) 和帕金森病 (PD) 的共病理现象。这些疾病有许多相同的临床症状和体征，因此在缺乏可靠生物标志物的情况下，进行鉴别诊断变得困难且耗时。

PET imaging of aggregated TDP-43 offers a new era for the development of disease-modifying therapies for TDP-43 proteinopathies, potentially revolutionizing both diagnosis and treatment..

PET成像技术对聚集的TDP-43进行可视化，为开发针对TDP-43蛋白病的疾病修饰疗法开启了新时代，可能彻底改变诊断和治疗方法。

The data showed that ACI-19626, a Morphomer

数据显示，ACI-19626，一种形态体

®

®

-based TDP-43 PET tracer, demonstrates high specificity and selectivity for the target, with rapid brain uptake and fast and complete washout, supporting the potential to detect TDP-43 pathology by PET in the brains of living patients.

基于TDP-43的PET示踪剂，对目标显示出高特异性和选择性，具有快速的脑摄取和快速且完全的清除，支持了通过PET检测活体患者大脑中TDP-43病理的可能性。

Dr.

博士

Andrea Pfeifer

安德烈亚·普菲弗

, CEO of

，首席执行官

AC Immune SA

AC Immune SA

, commented:

，评论道：

“Accurate PET imaging of TDP-43 pathology could significantly improve the diagnosis of multiple neurodegenerative diseases, paving the way to precision prevention with the possibility of intervening before damage occurs. This important diagnostic tool also has tremendous potential to improve the design and interpretation of clinical trials by enabling patient stratification, optimizing the timing of therapeutic intervention, and facilitating evaluation of target engagement and pharmacodynamic effects.

“准确的TDP-43病理PET成像可以显著改善多种神经退行性疾病的诊断，为精准预防铺平道路，并有可能在损害发生之前进行干预。这一重要的诊断工具还具有巨大的潜力，可以通过患者分层、优化治疗干预时机以及促进靶点参与和药效学效果的评估，从而改进临床试验的设计和解读。

Based on its advantageous profile, we took ACI-19626 forward into Phase 1 development and are looking forward to initial readout from that trial in Q4 2025, as we continue to pioneer the precision prevention of neurodegenerative diseases.”.

基于其优良的特性，我们已将ACI-19626推进到第一阶段开发，并期待在2025年第四季度获得该试验的初步结果，同时我们将继续开创神经退行性疾病的精准预防方法。

Dr.

博士

Francesca Capotosti

弗朗切斯卡·卡波托斯蒂

, VP Research of

，研究副总裁

AC Immune

AC免疫

added:

添加：

“PET imaging biomarkers have been proven to be potential game changers in the field of neurodegenerative diseases, as seen with amyloid PET in Alzheimer’s disease. We strongly believe that the detection of TDP-43 pathology by PET could not only support earlier and more definitive diagnosis but also accelerate drug development and open new avenues for combination therapies.” The paper in .

“PET成像生物标志物已被证明在神经退行性疾病领域具有潜在的变革性作用，正如在阿尔茨海默病中使用的淀粉样蛋白PET所见。我们坚信，通过PET检测TDP-43病理变化不仅可以支持更早和更明确的诊断，还可以加速药物开发，并为联合治疗开辟新途径。” 该论文发表在 。

Nature Communications

自然通讯

, entitled “

，标题为“

Development of [18F]ACI-19626 as a first-in-class brain PET tracer for imaging TDP-43 pathology

[18F]ACI-19626作为一类首创的脑PET示踪剂用于成像TDP-43病理的发展

”, reports the characterization of ACI-19626 with the preferred profile for the successful visualization of TDP-43 pathology in human brain by PET.

“，报告了ACI-19626的特性，该化合物具有通过PET成功可视化人类大脑中TDP-43病理的优选特性。”

Nature Communications

自然通讯

also published an accompanying

同时发布了一份相关的

commentary

评论

on the potential of TDP-43 PET ligands for biological diagnosis of TDP-43 proteinopathies.

关于TDP-43 PET配体在TDP-43蛋白病生物学诊断中的潜力。

Specifically, data on ACI-19626 in the paper showed:

具体来说，论文中关于 ACI-19626 的数据显示：

Based on these data, ACI-19626 was selected for further evaluation and is now in an ongoing Phase 1 clinical trial for its promising potential to detect pathological TDP-43 in the brains of patients with TDP-43 proteinopathies compared to healthy volunteers.

基于这些数据，ACI-19626被选中进行进一步评估，目前正在进行一项一期临床试验，因其有望检测到TDP-43蛋白病患者大脑中的病理性TDP-43，与健康志愿者相比。

Reference

参考文献

Efthymia Vokali

艾芙西米亚·沃卡利

et al

等人

., Development of [18F]ACI-19626 as a first-in-class brain PET tracer for imaging TDP-43 pathology,

[18F]ACI-19626作为首个用于成像TDP-43病理的一流脑PET示踪剂的开发，

Nature Communications

自然通讯

, 2025 16:9358.

，2025年16:9358。

About AC Immune SA

关于AC Immune SA

AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >.

AC Immune SA是一家临床阶段的生物制药公司，也是神经退行性疾病（包括阿尔茨海默病、帕金森病和由错误折叠蛋白引发的神经孤儿病）精准预防领域的全球领导者。公司拥有两个经过临床验证的技术平台——SupraAntigen®和Morphomer®，为其广泛且多样化的一流和最佳类资产管线提供支持，目前涵盖一系列治疗和诊断项目，包括处于二期和三期开发的候选药物。AC Immune在与全球领先的制药公司建立战略合作伙伴关系方面有着良好的记录，获得了大量的非稀释性资金，以推进其专有项目进展。

$4.5

4.5美元

billion in potential milestone payments plus royalties.

潜在的里程碑付款加上特许权使用费达数十亿美元。

SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of

SupraAntigen® 是 AC Immune SA 在以下地区（AU、EU、CH、GB、JP、RU、SG 和 USA）的注册商标。Morphomer® 是

AC Immune SA

AC Immune SA

in CN, CH, EU, GB, JP, KR, NO, RU and SG.

在中国、瑞士、欧盟、英国、日本、韩国、挪威、俄罗斯和新加坡。

The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.

我们网站以及本文提及的任何其他网站上的信息，明确声明不通过引用并入本新闻稿，也不构成本新闻稿的一部分。

For further information, please contact:

如需更多信息，请联系：

Forward looking statements

前瞻性声明

This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations.

本新闻稿包含构成《1933年证券法》第27A条和《1934年证券交易法》第21E条所指的“前瞻性陈述”。前瞻性陈述并非历史事实，可能包括涉及未来运营、财务或业务表现的陈述，或关于AC Immune的战略或预期的陈述。

In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements.

在某些情况下，您可以通过诸如“可能”、“也许”、“将”、“应该”、“预期”、“计划”、“预计”、“相信”、“估计”、“预测”、“展望”或“继续”等前瞻性词语来识别这些声明，以及其他类似的术语。前瞻性声明基于管理层的当前预期和信念，涉及重大风险和不确定性，可能导致实际结果、发展和业务决策与这些声明中设想的内容存在重大差异。

These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

这些风险和不确定性包括 AC Immune 年度 20-F 表格报告中“第三项：重要信息 - 风险因素”和“第五项：经营和财务回顾及展望”标题下描述的内容，以及向证券交易委员会提交的其他文件。前瞻性声明仅在其发布之日有效，AC Immune 没有义务根据新信息、未来发展或其他情况更新这些声明，除非适用法律可能要求。

All forward-looking statements are qualified in their entirety by this cautionary statement..

所有前瞻性陈述均受此警示性声明的全面限制。

Attachment

附件

Source: AC Immune SA

来源：AC Immune SA