A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants With Preclinical Alzheimer's Disease

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

开始日期2024-07-22

申办/合作机构

Janssen Pharmaceutica NV

ISRCTN78730935

/ Recruiting临床2期

A multicenter, randomized, placebo-controlled, double-blind, parallel-group study, to assess efficacy, safety and immunogenicity of JNJ-64042056, a phosphorylated tau targeted active immunotherapy, in participants with preclinical Alzheimer's disease

开始日期2024-05-28

申办/合作机构

Janssen-Cilag International NV

NL-OMON55583

/ CompletedN/A

A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects with Early Alzheimer*s Disease - ACI-35-1802

开始日期2019-09-09

申办/合作机构

AC Immune SA

100 项与 ACI-35.030 相关的临床结果

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100 项与 ACI-35.030 相关的转化医学

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100 项与 ACI-35.030 相关的专利（医药）

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项与 ACI-35.030 相关的文献（医药）

2025-10-01·EBioMedicine

Safety and immunogenicity of two Tau-targeting active immunotherapies, ACI-35.030 and JACI-35.054, in participants with early Alzheimer's disease: a phase 1b/2a, multicentre, double-blind, randomised, placebo-controlled study

Article

作者: Johannes Streffer ; Merja Hallikainen ; Paul Dautzenberg ; Bénédicte Lê ; Julien Mermoud ; Michael Jonsson ; Emma Fiorini ; Catherine Pennington ; David T. Hickman ; Sudhir Kurl ; Jonathan Wagg ; Nicolas Fournier ; Andrea Pfeifer ; Everard G.B. Vijverberg ; Craig Ritchie ; Viktoriia Gerasymchuk ; Clara Theunis ; Valérie Hliva ; Marie Kosco-Vilbois ; Anne Börjesson-Hanson ; Julian Gray ; Olivier Sol ; Lennert Steukers ; Iva Kezic ; Philip Scheltens ; Gallen Triana-Baltzer ; Juha Rinne ; Eva Gollwitzer ; Marija Vukicevic ; Catherine Mummery

BACKGROUND:

Active immunotherapies targeting C-terminal phosphorylated Tau species have the potential to efficiently reduce Tau spreading. ACI-35.030, a SupraAntigen®-based liposome, and JACI-35.054, a CRM197 carrier-protein conjugate, share the same immunogenic pTau sequence and were assessed to determine the best formulation for preferential activation of B cells specific to pathological Tau forms.

METHODS:

Individuals with early AD were enrolled in this randomised, double-blind, placebo-controlled study (NCT04445831). Participants were randomly assigned to 2 cohorts (ACI-35.030 at 300, 900, 1800 μg or placebo; and JACI-35.054 at 15, 60 μg or placebo) and received 4 intramuscular injections over 48 weeks, followed up to week 74. Participants receiving at least one dose of study drug were included in the intention-to-treat analysis. The primary objectives were safety, tolerability and immunogenicity.

FINDINGS:

Among the 57 randomised participants, 41 were assigned to the ACI-35.030 cohort and 16 to the JACI-35.054 cohort. The most frequent adverse events observed consistently in both active groups were injection site reactions (16.7%-100%) and headaches (16.7%-50%). No relevant MRI findings and no adverse events leading to study discontinuation were reported. ACI-35.030 required only one injection to induce anti-pTau IgG titres in all participants and consistently boosted levels with subsequent immunisations. JACI-35.054 raised a strong but more heterogenous anti-pTau IgG response and required multiple administrations to reach consistent titres in all participants. ACI-35.030 induced a robust polyclonal antibody response binding enriched PHF from AD brain tissue while concurrently sparing the response to non-phosphorylated Tau. A post-hoc statistical analysis revealed statistically significant differences between some randomised actively treated groups and the pooled placebo group on plasma pTau217 and brain-derived Tau changes from baseline.

INTERPRETATION:

ACI-35.030 and JACI-35.054 were well tolerated. ACI-35.030 induced a more rapid and sustained antibody response selective to p-Tau species with evidence of altering AD-related plasma biomarkers and was selected for testing in the ongoing Phase 2b trial.

FUNDING:

AC Immune SA and Johnson & Johnson Innovative Medicine.

2016-02-01·Pharmacological reports : PR4区 · 医学

Therapeutic strategies for Alzheimer's disease in clinical trials

4区 · 医学

Review

作者: Malawska, Barbara ; Panek, Dawid ; Jończyk, Jakub ; Godyń, Justyna

Alzheimer's disease (AD) is considered to be the most common cause of dementia and is an incurable, progressive neurodegenerative disorder. Current treatment of the disease, essentially symptomatic, is based on three cholinesterase inhibitors and memantine, affecting the glutamatergic system. Since 2003, no new drugs have been approved for treatment of AD. This article presents current directions in the search for novel, potentially effective agents for the treatment of AD, as well as selected promising treatment strategies. These include agents acting upon the beta-amyloid, such as vaccines, antibodies and inhibitors or modulators of γ- and β-secretase; agents directed against the tau protein as well as compounds acting as antagonists of neurotransmitter systems (serotoninergic 5-HT6 and histaminergic H3). Ongoing clinical trials with Aβ antibodies (solanezumab, gantenerumab, crenezumab) seem to be promising, while vaccines against the tau protein (AADvac1 and ACI-35) are now in early-stage trials. Interesting results have also been achieved in trials involving small molecules such as inhibitors of β-secretase (MK-8931, E2609), a combination of 5-HT6 antagonist (idalopirdine) with donepezil, inhibition of advanced glycation end product receptors by azeliragon or modulation of the acetylcholine response of α-7 nicotinic acetylcholine receptors by encenicline. Development of new effective drugs acting upon the central nervous system is usually a difficult and time-consuming process, and in the case of AD to-date clinical trials have had a very high failure rate. Most phase II clinical trials ending with a positive outcome do not succeed in phase III, often due to serious adverse effects or lack of therapeutic efficacy.

PloS one3区 · 综合性期刊

Efficacy and Safety of A Liposome-Based Vaccine against Protein Tau, Assessed in Tau.P301L Mice That Model Tauopathy

3区 · 综合性期刊

ArticleOA

作者: María Pilar López-Deber ; Peter Borghgraef ; Natalia Crespo-Biel ; Fred Van Leuven ; Oskar Adolfsson ; Valérie Gafner ; Andreas Muhs ; Pedro Reis ; Andrea Pfeifer ; Clara Theunis ; Nathalie Chuard ; David T. Hickman ; Herman Devijver ; Dorin Mlaki Ndao ; Maria Pihlgren

Progressive aggregation of protein Tau into oligomers and fibrils correlates with cognitive decline and synaptic dysfunction, leading to neurodegeneration in vulnerable brain regions in Alzheimer's disease. The unmet need of effective therapy for Alzheimer's disease, combined with problematic pharmacological approaches, led the field to explore immunotherapy, first against amyloid peptides and recently against protein Tau. Here we adapted the liposome-based amyloid vaccine that proved safe and efficacious, and incorporated a synthetic phosphorylated peptide to mimic the important phospho-epitope of protein Tau at residues pS396/pS404. We demonstrate that the liposome-based vaccine elicited, rapidly and robustly, specific antisera in wild-type mice and in Tau.P301L mice. Long-term vaccination proved to be safe, because it improved the clinical condition and reduced indices of tauopathy in the brain of the Tau.P301L mice, while no signs of neuro-inflammation or other adverse neurological effects were observed. The data corroborate the hypothesis that liposomes carrying phosphorylated peptides of protein Tau have considerable potential as safe and effective treatment against tauopathies, including Alzheimer's disease.

项与 ACI-35.030 相关的新闻（医药）

2026-08-11

·BioSpace

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD) Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and immunogenicity with early signals of activity Full week-100 results from Part 1 of VacSYn trial expected in H2 2026 Lausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company developing targeted therapeutics for neurodegenerative diseases, today announced that it has received Fast Track designation and clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson’s disease (PD). ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognizing aggregated a-syn species that are toxic to neurons. The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson’s disease, with final Part 1 week-100 results on track to be announced in H2. Martin Zügel, interim CEO of AC Immune SA, commented: “ Fast Track designation and IND clearance from the FDA are important achievements for ACI-7104, one of our wholly-owned programs, given its potential to address the significant unmet need in Parkinson’s. We look forward to working closely with the FDA as we advance ACI-7104 through its ongoing clinical development towards potentially delivering a much-needed treatment option for patients. ” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); FDA Fast Track designation reflects the early interim Phase 2 data demonstrating safety, tolerability and immunogenicity, and providing first signals that targeting underlying a-syn pathology with an active immunotherapy could potentially impact PD. The interim results, reported for Part 1 of the study at 76 weeks, successfully demonstrated ACI-7104 was safe and well tolerated, with no clinically relevant safety issues being reported. Targets were also met for immunogenicity with a 100% responder rate. AC Immune recently announced a $4 million research grant from the Vijay and Marie Goradia Charitable Foundation to support the extension of Part 1 of the VacSYn trial, enabling the assessment of long-term safety and efficacy of ACI-7104 for an additional two years. Günther Staffler, Executive Vice President, Development at AC Immune SA, commented: “ ACI-7104 represents a promising active immunotherapy designed to target pathological a-syn for the treatment of prodromal and early PD. The FDA’s decision signifies the growing importance of the program including the positive interim Phase 2 findings. This is a key regulatory milestone for the program, and we look forward to delivering the full results from Part 1 of the VacSYn trial in the coming months.” About ACI-7104 ACI-7104 is an optimized formulation of AC Immune’s anti-a-syn predecessor active immunotherapy which generated an antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease. The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contributes to the degeneration of neurons in the brain, linking it to the development of neurodegenerative diseases such as Parkinson’s Disease. About AC Immune SA AC Immune (NASDAQ: ACIU) is a clinical stage biopharmaceutical company developing a pipeline of products, including both active immunotherapies and small molecules, targeting key misfolded proteins and pathways for the treatment of multiple neurodegenerative diseases. The company has a growing focus on its wholly owned proprietary clinical-stage programs, including: ACI-7104, an active immunotherapy targeting α-synuclein (α-syn) in Parkinson's disease; and ACI-19764, a small molecule inhibitor of the NLRP3 inflammasome. In addition, an early-stage small molecule development program targeting intracellular a-syn is advancing towards the clinic. ACIU has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding and >$4.5 billion in potential milestone payments. ACIU’s pharma-partnered programs, all in Alzheimer’s disease, include: a collaboration on ACI-24, an active immunotherapy targeting Abeta; a collaboration on ACI-35 targeting phospho-Tau; and a collaboration developing brain-penetrant small molecule drugs targeting intracellular pathologic Tau. All trademarks used or mentioned in this release are protected by law. 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. For further information, please contact: SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com International Media Optimum Strategic Communications Nick Bastin, Joshua Evans, Aoife Minihan, Ben Cowe Phone: +44 (0) 20 4566 8543 Email: acimmune@optimumcomms.com Forward looking statements 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. 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. 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. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. 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. All forward-looking statements are qualified in their entirety by this cautionary statement. Attachment 20260810__ACIU ACI-7104 IND+FastTrack PR_final

临床2期免疫疗法临床结果快速通道临床申请

2026-08-07

·阿尔茨海默病研究

AC Immune管线全景：全球首款进入II期AD Tau主动疫苗ACI-35.030、罗氏合作抗Tau单抗Semorinemab与Morphomer小分子平台解析

一、企业基础信息 AC Immune SA为2003年成立的临床阶段神经退行性疾病精准生物制药企业，纳斯达克股票代码ACIU，官方网址https://www.acimmune.com/，总部坐落于瑞士洛桑EPFL创新园区，在美国设有子公司，依托SupraAntigen®、Morphomer®两大核心技术平台布局主动免疫疫苗、单克隆抗体、小分子聚集抑制剂管线，长期入选Cummings全球阿尔茨海默病研发管线榜单，多次在CTAD大会披露Tau管线临床数据。二、公司核心研发团队布局公司由Andrea Pfeifer教授担任首席执行官，核心科研团队围绕错误折叠蛋白病理机制搭建技术转化体系，疫苗管线与强生杨森达成战略合作，被动抗体管线早期与罗氏开展联合开发，小分子管线依托自有Morphomer®化合物库独立推进IND转化；临床运营覆盖欧洲、北美多中心试验网络，临床前药理、CMC工艺以内部平台+CRO外包结合模式落地，同步布局AD影像诊断探针实现诊疗一体化布局。三、AD核心管线与技术布局1. ACI-35.030（靶向磷酸化Tau主动免疫疫苗，全球首个进入II期的AD Tau疫苗，杨森联合开发，通用代号JNJ-64042056） ACI-35.030基于自研SupraAntigen®脂质体抗原递送平台设计，特异性靶向病理性磷酸化Tau（pTau）成对螺旋丝（ePHF）抗原表位，仅诱导针对病变Tau的特异性IgG抗体，不干扰生理型Tau蛋白功能，核心作用机制是阻断Tau病理蛋白在脑内的跨细胞播种扩散，遏制神经原纤维缠结进展。Ib/IIa期临床试验（NCT04445831）为随机双盲安慰剂对照设计，纳入轻度AD或AD源性MCI受试者，梯度剂量组结果显示全部给药受试者均可快速产生抗pTau特异性抗体，高剂量组抗体应答可持续至74周，同时显著下调血浆pTau217、脑源性Tau生物标志物水平，全试验仅出现轻微注射部位反应，无严重中枢免疫炎症不良反应。该项目是全球首款推进至II期临床的阿尔茨海默病Tau主动疫苗，基于Ib/IIa期阳性免疫原性与生物标志物数据，公司启动IIb期关键性ReTain研究（NCT06544616），计划入组近500例临床前AD人群，以PACC-5认知复合评分为主要疗效终点，最长随访周期4年，Tau PET影像作为病理缓解次要终点，数据可支撑潜在加速上市申报，2021年CTAD大会首次对外披露中期临床免疫原性数据。2. Semorinemab（抗Tau单克隆抗体，罗氏联合开发，II期临床完成） Semorinemab为靶向总Tau的全人源单克隆抗体，由AC Immune早期完成分子发现，罗氏获得全球联合开发权益，静脉给药用于早期阿尔茨海默病治疗，核心机制为结合胞外游离Tau寡聚体，阻断病理Tau细胞间转运。两项全球II期临床试验（TAURIEL、LAURIET）分别针对前驱AD、轻度AD人群开展，完整临床结果显示药物安全性整体可控，但未达到认知功能与日常生活能力复合主要终点，罗氏后续决定终止该分子III期开发，AC Immune保留抗体技术平台经验用于下一代Tau单抗分子优化。3. Morphomer®小分子技术平台（Tau聚集抑制剂临床前管线） Morphomer®是AC Immune自有小分子药物发现平台，聚焦筛选可穿透血脑屏障的小分子化合物，选择性结合错误折叠Tau、Aβ蛋白，抑制蛋白寡聚化与纤维聚集，同时具备稳定蛋白构象、降低病理蛋白播种活性的作用。平台核心Tau聚集抑制剂管线处于IND申报准备阶段，计划2026年上半年启动IND-enabling药理毒理研究，适配作为疫苗、单抗的联合口服配套药物，覆盖Tau病理中晚期干预场景，平台同时衍生NLRP3炎症小体抑制剂ACI-19764进入I期临床，完善神经炎症协同治疗管线储备。四、最新重磅新闻 2025年ACI-35.030 Ib/IIa期完整临床研究成果正式发表于《eBioMedicine》，验证疫苗对血浆Tau标志物的调控作用；IIb期ReTain研究持续在欧美多中心开展受试者招募，是当前Tau主动疫苗赛道规模最大的II期注册导向临床试验；Semorinemab项目临床数据作为Tau被动抗体经典阴性案例持续在AD学术会议复盘；Morphomer小分子Tau抑制剂稳步推进临床前开发，公司整体管线重心聚焦ACI-35.030中后期临床落地，依托杨森商业化资源对接欧美市场注册路径。五、管线发展关键时间线（表格形式）时间节点研发进展（临床/CTAD/AAIC披露）融资/资本动作收并购/合作团队重大变动 2003年 AC Immune于瑞士洛桑成立，搭建SupraAntigen、Morphomer两大核心技术平台早期科研基金支撑平台搭建多位学术奠基人完成靶点专利布局创始科研管理团队组建落地 2010–2015年初代ACI-35 Tau疫苗完成I期临床验证，启动第二代ACI-35.030分子优化；Semorinemab分子发现，与罗氏达成抗Tau抗体合作自有研发资金投入管线开发罗氏签约获得Semorinemab联合开发权益抗体、疫苗两大专项研发组分立运作 2016年公司登陆纳斯达克上市（ACIU） IPO募资用于临床管线推进无并购动作扩充全球临床注册团队 2019–2020年 Semorinemab两项II期临床试验完成入组；ACI-35.030启动Ib/IIa期临床（NCT04445831）定向增发补充临床资金与强生杨森签约，获得ACI-35.030全球联合开发权疫苗管线专项团队扩容 2021年 CTAD 2021发布ACI-35.030中期安全性与免疫原性数据无大额融资无无核心高管调整 2022年罗氏官宣终止Semorinemab后续III期开发；AC Immune规划ACI-35.030 IIb期试验方案成本优化，收缩被动抗体管线投入暂停罗氏后续抗体联合研发合作缩减Semorinemab项目人员，全部资源倾斜Tau疫苗管线 2023年 ACI-35.030 IIb期ReTain研究（NCT06544616）正式启动入组无专项管线融资无临床运营团队扩充北美区域人员 2025年 ACI-35.030 Ib/IIa期完整研究见刊；Morphomer Tau小分子进入IND准备阶段常规资本市场融资维持运营无小分子药物研发团队扩充 2026年 Morphomer平台计划启动Tau聚集抑制剂IND申报研究持续开展BD商务合作洽谈探索ACI-35.030联合小分子给药临床设计无重大架构调整 AC Immune全程以平台授权、战略合作模式推进管线开发，无大型药企并购交易，管线迭代依靠两大自有技术平台持续输出差异化候选药物。六、简要评价 AC Immune是全球Tau靶向阿尔茨海默病治疗赛道布局最完整的Biotech企业，实现主动免疫疫苗、被动单克隆抗体、口服小分子聚集抑制剂三种技术形态全覆盖，ACI-35.030作为里程碑式Tau主动疫苗，填补了AD Tau疫苗II期临床空白，特异性靶向病变Tau的设计规避了初代Aβ疫苗的自身免疫损伤风险，长效免疫应答特性大幅降低长期治疗给药频次，适配临床前AD早期干预场景。Semorinemab的临床失利印证了单一被动Tau抗体的开发瓶颈，反向凸显主动疫苗持续内源抗体生成的差异化优势；Morphomer小分子平台可形成“疫苗长期预防+小分子急性期干预”的组合疗法方案，丰富商业化产品矩阵。企业短板在于整体现金流依赖资本市场与合作方里程碑付款，ReTain大型IIb期试验研发开支较高，管线价值高度绑定ACI-35.030临床终点结果；优势是Tau全链条技术壁垒扎实，完整的临床前至II期数据积累，一旦IIb期认知终点阳性，可快速依托杨森实现全球商业化落地，重塑AD Tau靶向治疗的市场格局。参考文献 AC Immune 2025 Clinical Pipeline Update[EB/OL].https://www.acimmune.comAC Immune. Phase 1b/2a ACI-35.030 Publication Release[EB/OL].https://ir.acimmune.comNeurologyLive. AC Immune ReTain Phase 2 Trial Launch Report,2023https://doi.org/10.1016/j.ebiom.2025.107241专业缩写释义 AD，ACI-35.030，Semorinemab，Morphomer®，SupraAntigen®，pTau（磷酸化Tau），ePHF（成对螺旋丝），MCI（轻度认知障碍），CTAD，PACC-5，IND 本文内容来自公开信息及研究文献，不代表临床建议。如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）

2026-08-05

·BioSpace

AC Immune First Half 2026 Financial and Corporate Update

AC Immune First Half 2026 Financial and Corporate Update Focused portfolio of wholly-owned programs approach near-term clinical catalysts as partnered programs generate milestone payments Key advances across pipeline, with further near-term clinical results anticipated for H2 2026 Phase 2 VacSYn trial of ACI-7104 in Parkinson’s disease supported by a $4 million grant from The Vijay and Marie Goradia Charitable Foundation Morphomer small molecule program targeting intracellular Tau progresses with Lilly Initiation of Alzheimer’s disease AD4 cohort in ABATE trial triggered $12 million milestone payment from Takeda Cash resources of CHF 75.4 million as of June 30, 2026, provide funding into Q4 2027 Lausanne, Switzerland, August 5, 2026 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company developing targeted therapeutics for neurodegenerative diseases, today provided a corporate and financial update for the half-year ended June 30, 2026. Martin Zügel, MD, interim CEO of AC Immune and Chair of the Board of Directors, commented: “AC Immune is moving towards key clinical milestones in two of our wholly-owned programs, a growing focus for AC Immune. These data include full results from Part 1 of the VacSYn trial of ACI-7104, our anti-α-syn active immunotherapy in Parkinson’s disease, as well as initial data from our ACI-19764 trial. The important milestone payments in our partnered programs ensure we are funded into Q4 2027, and that we are well-positioned as we approach these near-term clinical results.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); First Half 2026 and Subsequent Highlights: Wholly-Owned Programs AC Immune’s wholly-owned pipeline is built around three differentiated programs against α-synuclein, TDP-43, and NLRP3, targeting key mechanisms underlying neurodegenerative disease based on extensive preclinical data. The following updates focus on our clinical stage programs. ACI-7104 is an active immunotherapy targeting pathological α-synuclein in Parkinson’s disease, designed to generate a targeted immune response with the potential to modify disease progression. ACI-19764 is a small-molecule NLRP3 inflammasome inhibitor aimed at reducing neuroinflammation, a fundamental driver of multiple neurodegenerative disorders. ACI-19626 is a first-in-class TDP-43 PET tracer designed to visualize TDP-43 pathology in living patients, addressing a major unmet need in ALS and related diseases. Together, these assets provide multiple near-term data catalysts and showcase AC Immune’s ability to translate deep neuroscience expertise into both therapeutics and diagnostics. ACI-7104: anti-a-syn active immunotherapy The VacSYn placebo-controlled Phase 2 clinical trial continues, with full results from the complete data set for Part 1 of the trial at week 104 expected to be reported in H2 2026. Clinicaltrials.gov identifier: NCT06015841 Part 1 of the ongoing Phase 2 VacSYn trial of ACI-7104 in early Parkinson’s disease (PD) was extended and received support via a research grant of $4 million from The Vijay and Marie Goradia Charitable Foundation . Previously reported interim results from Part 1 at 76 weeks included changes in biomarkers and clinical measures assessed as signals of the potential impact of treatment with ACI-7104. Results to support further development of the program and discussion with regulators to establish a clinical development plan towards registration. ACI-19764: brain penetrant NLRP3 inhibitor Phase 1 trial in healthy volunteers continues, with initial SAD/MAD and pharmacodynamics results expected in the near future. These will be followed later in H2 2026 by Phase 1b results on reductions in hsCRP levels in a cohort of patients with CV-risk factors and elevated hsCRP on entry into the trial. ACI-19626: TDP-43 PET tracer Presented new preliminary results from a Phase 1 clinical trial of first-in-class TDP-43 positron emission tomography (PET) tracer ACI-19626 showing increased uptake in the brains of patients with amyotrophic lateral sclerosis (ALS). Partnered Programs AC Immune’s partnered portfolio validates the strength of its neuroscience platform through collaborations with leading global pharmaceutical companies. The pipeline includes anti-amyloid and anti-tau programs developed in collaboration with Takeda, Lilly, and Janssen, leveraging AC Immune’s expertise in protein misfolding and neurodegenerative disease biology. The portfolio also includes diagnostic imaging assets developed with partners to improve patient identification, stratification and treatment monitoring. These partnerships provide access to substantial development resources, milestone and royalty opportunities, and multiple clinical catalysts. ACI-24: anti-Abeta active immunotherapy Dosed the first patients in Cohort AD4 in the ongoing Phase 1b/2 ABATE trial of ACI-24 to treat prodromal Alzheimer’s disease (AD). Cohort AD4 is evaluating enhancing ACI-24 with an additional adjuvant to boost immunogenicity. Following the cohort initiation, a $12 million milestone payment from partner Takeda was triggered. Reported high level interim data from the first three cohorts (AD1, AD2 & AD3) of 74 prodromal AD patients in the ABATE trial, following 12 months of treatment. ACI-24 has been generally safe and well tolerated, with no evidence of amyloid-related imaging abnormalities-edema (ARIA-E). Anti-Abeta antibody responses were detected at every dose level. Morphomer-Tau small molecule program Amended agreement with Lilly continues the research and collaboration to include development of new lead Tau Morphomer® candidates and potential back-up compounds, reflecting growing excitement for targeting intracellular Tau and significant progress made with our Morphomer small molecules. AC Immune received a CHF10 million upfront payment and will receive a subsequent milestone payment subject to Phase 1 dosing, in addition to other potential development, regulatory and commercial milestones of over CHF1.7 billion, plus tiered percentage royalty payments in the low double digits, as previously disclosed. Corporate Governance After long service Dr Andrea Pfeifer retired from her role as Chief Executive Officer (CEO) of AC Immune at the Annual General Meeting (AGM) to spend more time with her family. AC Immune’s Board of Directors appointed the Chair, Dr Martin Zügel, to serve as interim CEO whilst a diligent search for a permanent successor continues apace. All agenda items at the AGM were approved by shareholders. Anticipated 2026 Milestones Program Milestone Expected in ACI-7104.056 anti-a-syn active immunotherapy Final data from Part 1 of the Phase 2 VacSYn trial in PD H2 2026 ACI-19764 NLRP3 inhibitor Results from Phase 1 trial in healthy volunteers H2 2026 Results from Phase 1b in patient cohort H2 2026 Morphomer a-syn aggregation inhibitor Lead declaration H2 2026 Analysis of Financial Statements for the Half-year Ended June 30, 2026 Cash Position: The Company had total cash resources of CHF75.4 million (CHF91.4 million as of December 31, 2025), composed of CHF27.8 million in cash and cash equivalents and CHF47.6 million in short-term financial assets. The Company’s cash resources are expected to provide sufficient capital to last into Q4 2027, excluding potential milestone payments. Revenue: Total revenues for the six months ended June 30, 2026 were CHF16.2 million compared with CHF2.3 million for the same period in 2025. The increase was due to the achievement of milestones following the amended Lilly agreement resulting in CHF11.0 million of revenue recognized, and efforts under the Takeda arrangements resulting in CHF5.2 million of revenue recognized. R&D expenditures: R&D expenses for the six months ended June 30, 2026, were CHF22.2 million, compared with CHF32.7 million for the comparable period in 2025. The decrease was partly due to lower personnel and operational spend of approximately CHF4.9 million, largely as a result of our pipeline focus initiatives announced in Q3 2025. Additional decreases of CHF5.8 million resulted from lower spend in our clinical programs including our active immunotherapy programs which had non-recurring manufacturing costs in the prior period. These decreases were offset by increased costs of CHF1.9 million relating to our NLRP3 inhibitor small molecule entering Phase 1 clinical development. G&A expenditures: G&A expenses in the period were CHF7.7 million in the period ended June 30, 2026, compared to CHF8.3 million for same period in 2025. The decrease reflects the lower personnel costs as a result of our pipeline focus initiatives announced in Q3 2025. Financial result: The financial result was a gain of CHF0.7 million for the period, compared with a loss of CHF1.5 million for the comparable period. The change was primarily driven by an increase in foreign exchange gains of CHF2.9 million, partially offset by a decrease in interest income earned on short-term financial assets of CHF0.7 million. IFRS loss for the period: The Company had a net loss of CHF12.9 million for the period ended June 30, 2026, compared to CHF40.2 million for the same period in 2025. About AC Immune SA AC Immune (NASDAQ: ACIU), is a clinical stage biopharmaceutical company developing a pipeline of products, including both active immunotherapies and small molecules, targeting key misfolded proteins and pathways for the treatment of multiple neurodegenerative diseases. The company has a growing focus on its wholly owned proprietary clinical stage programs, including: ACI-7104, an active immunotherapy targeting α-synuclein (α-syn) in Parkinson's disease; and ACI-19764, a small molecule inhibitor of the NLRP3 inflammasome. In addition, an early-stage small molecule development program targeting intracellular a-syn is advancing towards the clinic. ACIU has a strong track record of securing strategic partnerships with leading global pharmaceutical companies resulting in substantial non-dilutive funding and >$4.5 billion in potential milestone payments. ACIU’s pharma partnered programs, all in Alzheimer’s disease, include: a collaboration on ACI-24, an active immunotherapy targeting Abeta; a collaboration on ACI-35 targeting phospho-Tau; and a collaboration developing brain-penetrant small molecule drugs targeting intracellular pathologic Tau. 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 AC Immune SA in CA, CN, CH, EU, GB, JP, KR, NO, RU and SG. 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. For further information, please contact: SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com International Media Optimum Strategic Communications Nick Bastin, Joshua Evans, Aoife Minihan, Ben Cowe Phone: +44 (0) 20 4566 8543 Email: acimmune@optimumcomms.com Forward looking statements 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. 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. 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. All forward-looking statements are qualified in their entirety by this cautionary statement. Condensed Consolidated Balance Sheets (Unaudited) (In CHF thousands) As of June 30, December 31, 2026 2025 Assets Non-current assets Property, plant and equipment 1,919 1,989 Right-of-use assets 4,080 4,540 Intangible asset 50,416 50,416 Long-term financial assets 585 584 Total non-current assets 57,000 57,529 Current assets Prepaid expenses 4,399 3,972 Accrued income 209 360 Other current receivables 3,514 978 Accounts receivable 9,922 — Short-term financial assets 47,600 64,617 Cash and cash equivalents 27,757 26,795 Total current assets 93,401 96,722 Total assets 150,401 154,251 Shareholders' equity and liabilities Shareholders’ equity Share capital 2,263 2,253 Share premium 483,550 481,863 Treasury shares (213) (218) Currency translation differences 9 7 Accumulated losses (450,440) (439,021) Total shareholders’ equity 35,169 44,884 Non-current liabilities Long-term deferred income 1,830 — Long-term deferred contract revenue 806 2,339 Long-term lease liabilities 3,267 3,689 Net employee defined benefit liabilities 9,090 8,646 Total non-current liabilities 14,993 14,674 Current liabilities Trade and other payables 1,513 2,068 Accrued expenses 7,122 8,067 Short-term deferred income 1,292 — Short-term deferred contract revenue 89,477 83,706 Short-term lease liabilities 835 852 Total current liabilities 100,239 94,693 Total liabilities 115,232 109,367 Total shareholders’ equity and liabilities 150,401 154,251 Condensed Consolidated Statements of Income/(Loss) (Unaudited) ( In CHF thousands, except for per-share data) For the Six Months Ended June 30, 2026 2025 Revenue Contract revenue 16,232 2,296 Total revenue 16,232 2,296 Operating expenses Research & development expenses (22,220) (32,742) General & administrative expenses (7,714) (8,334) Other operating income/(expense), net 107 21 Total operating expenses (29,827) (41,055) Operating loss (13,595) (38,759) Financial income 399 1,145 Financial expense (126) (103) Exchange differences 395 (2,501) Finance result, net 668 (1,459) Loss before tax (12,927) (40,218) Income tax expense — — Loss for the period (12,927) (40,218) Loss per share: Basic and diluted loss per share for the period attributable to equity holders (0.13) (0.40) Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited) (In CHF thousands) For the Six Months Ended June 30, 2026 2025 Loss for the period (12,927) (40,218) Items that will be reclassified to income or loss in subsequent periods (net of tax): Currency translation differences: 2 9 Other comprehensive income/(loss) 2 9 Total comprehensive loss, net of tax (12,925) (40,209) Attachment 20260804__ACIU H1-Q2 2026 PR_Final

100 项与 ACI-35.030 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床2期	芬兰	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	芬兰	Janssen Research & Development LLC	2019-07-31
阿尔茨海默症	临床2期	荷兰	Janssen Research & Development LLC	2019-07-31
阿尔茨海默症	临床2期	荷兰	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	瑞典	AC Immune SA	2019-07-31
阿尔茨海默症	临床2期	英国	AC Immune SA	2019-07-31
轻度认知障碍	临床2期	芬兰	Janssen Research & Development LLC	2019-07-31
轻度认知障碍	临床2期	芬兰	AC Immune SA	2019-07-31
轻度认知障碍	临床2期	荷兰	AC Immune SA	2019-07-31
轻度认知障碍	临床2期	荷兰	Janssen Research & Development LLC	2019-07-31

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04445831 (EBioMedicine) 人工标引	临床1/2期	阿尔茨海默症	57	ACI‑35.030 (all doses (300/900/1800 µg))	襯餘範鏇鏇淵鬱範鹹齋(獵鬱夢鹹繭壓壓襯願願) = ACI‑35.030: 100% responders after 1st injection; sustained 94–100% at high dose until wk74. JACI‑35.054: Heterogeneous; required ≥2 injections to reach 100% responders. Placebo: 4 pts from the pooled placebo group had anti-pTau IgG titres slightly above the responder threshold at sporadic timepoints due to some variability inherent to the assay. 襯窪衊齋艱淵觸網鹹簾 (醖網襯鏇構獵蓋獵醖膚 ) 更多	积极	2025-09-18
				JACI‑35.054 (all doses (15/60 µg))
NCT04445831 (CTgov)	临床1/2期	阿尔茨海默症 \| 认知功能障碍 \| 轻度认知障碍	57	ACI-35.030 (Sub-Cohort 1.1 (ACI-35.030 300 μg))	範築艱鹹製網鑰製築窪 = 製憲積簾願夢醖齋鏇範範獵顧顧築鬱齋範簾網 (簾壓淵構廠膚獵廠鏇淵, 選醖醖鬱鬱鑰艱糧襯觸 ~ 獵鹹遞夢淵夢簾構簾夢) 更多	-	2025-02-14
				ACI (Sub-Cohort 1.2 (ACI-35.030 900 μg))	範築艱鹹製網鑰製築窪 = 膚觸繭壓鏇淵餘齋鬱窪範獵顧顧築鬱齋範簾網 (簾壓淵構廠膚獵廠鏇淵, 糧鑰鏇範遞壓餘廠遞齋 ~ 淵網餘鏇壓鑰蓋壓醖齋) 更多