OSAKA, Japan & CAMBRIDGE, Mass & LAUSANNE, Switzerland--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and AC Immune SA (NASDAQ: ACIU) today announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease..

日本大阪和瑞士马萨诸塞州剑桥和洛桑--（商业新闻短讯）--武田（东京证交所：4502/纽约证交所：TAK）和AC Immune SA（纳斯达克：ACIU）今天宣布了AC Immune针对有毒形式的β淀粉样蛋白（Abeta）的主动免疫疗法的独家全球选择和许可协议，包括用于治疗阿尔茨海默氏病的ACI-24.060。。

ACI-24.060 is an anti-Abeta active immunotherapy candidate designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer’s disease progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24.060 has the potential to delay or slow Alzheimer’s disease progression.

ACI-24.060是一种抗Abeta活性免疫治疗候选药物，旨在诱导针对Abeta毒性形式的强大抗体反应，据信Abeta会驱动斑块形成和阿尔茨海默氏病进展。通过诱导斑块清除并有效抑制大脑中的斑块形成，ACI-24.060有可能延缓或减缓阿尔茨海默病的进展。

ACI-24.060 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of the investigational immunotherapy in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome..

ACI-24.060正在进行ABATE随机，双盲，安慰剂对照的1b/2期临床试验中进行研究，以评估研究性免疫疗法对前驱阿尔茨海默病患者和唐氏综合征患者的安全性，耐受性，免疫原性和药效学影响。。

“As pioneers in the field of active immunotherapy, we are developing an innovative approach that could change the treatment paradigm for Alzheimer’s disease and address the multifaceted burden that patients and the broader community face. We believe the maximum impact of ACI-24.060 can best be realized by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into Phase 3,” said Dr.

“作为主动免疫治疗领域的先驱，我们正在开发一种创新方法，可以改变阿尔茨海默病的治疗模式，并解决患者和更广泛的社区面临的多方面负担。我们相信ACI-24.060的最大影响可以通过在其发展的关键时刻与武田合作来实现，这将有助于我们迅速进入第三阶段，”博士说。

Andrea Pfeifer, CEO of AC Immune. “This agreement allows us to leverage the developmental expertise, strategic vision and financial capacity of an accomplished organization that has demonstrated its ability to execute the type of comprehensive global program required for Phase 3 trials in Alzheimer’s disease while allowing us to focus on completing Phase 1b/2 development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline.”.

AC Immune首席执行官Andrea Pfeifer。“该协议使我们能够利用一个成熟组织的发展专业知识、战略愿景和财务能力，该组织已证明其有能力执行阿尔茨海默氏病第三阶段试验所需的全面全球计划，同时使我们能够专注于完成1b/2期开发，并通过为我们的早期管道提供更多资金，加速我们复制这一成功的努力。”。

AC Immune will be responsible for completing the ABATE trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.

AC Immune将负责完成ABATE试验。在期权行使之后，武田将进行并资助所有进一步的临床开发，并负责所有全球监管活动以及全球商业化。

“At Takeda, we are committed to tackling some of society’s most debilitating illnesses, including Alzheimer’s disease. We are excited to partner with AC Immune on this ground-breaking treatment approach, which leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety and ease of administration,” said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda.

“在武田，我们致力于解决一些社会上最令人衰弱的疾病，包括阿尔茨海默氏病。我们很高兴能与AC Immune合作，采用这种开创性的治疗方法，利用新技术，有可能为患者提供不同疗效，安全性和易于管理的治疗，”Sarah Sheikh，M.Sc.，B.M.，B.Ch，MRCP，神经科学治疗领域部门负责人和武田全球发展负责人说。

“Combining AC Immune’s deep experience with active immunotherapy approaches with Takeda’s expertise in neuroscience drug development and commercialization, we have an incredible opportunity to deliver real impact to the Alzheimer’s community.”.

“将AC Immune的丰富经验与主动免疫治疗方法相结合，再加上武田在神经科学药物开发和商业化方面的专业知识，我们有一个难以置信的机会为阿尔茨海默氏病社区带来真正的影响。”。

Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million and be eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved over the course of the agreement.

根据协议条款，如果在协议过程中实现了所有相关里程碑，AC Immune将获得1亿美元的预付款，并有资格获得期权行权费以及高达21亿美元的额外潜在开发、商业和销售里程碑。

Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales..

商业化后，AC Immune将有权在全球净销售额上获得两位数的分层版税。。

Further details related to the agreement are available in the Form 6-K filed today by AC Immune with the U.S. Securities and Exchange Commission (SEC). The effectiveness of Takeda's license following option exercise is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act..

AC Immune今天向美国证券交易委员会（SEC）提交的表格6-K中提供了与该协议有关的更多详细信息。行使期权后，武田许可证的有效性取决于《哈特·斯科特·罗迪诺法案》规定的任何适用等待期的终止或到期。。

Conference Call and Webcast Information

电话会议和网络广播信息

AC Immune management will host a conference call and webcast today at 8:30 a.m. ET to provide a brief overview of the agreement.

AC Immune management将于美国东部时间今天上午8:30举行电话会议和网络广播，简要介绍该协议。

About ACI-24.060

关于ACI-24.060

This product is AC Immune’s anti-Abeta active immunotherapy candidate. The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24.060 for treatment of Alzheimer’s disease (AD) continues fully blinded (NCT05462106). Enrolled patients are required to have a diagnosis of prodromal AD: MCI due to AD according to the National Institute on Aging Alzheimer’s Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence of amyloid pathology.

该产品是AC Immune的抗Abeta活性免疫疗法候选产品。ACI-24.060治疗阿尔茨海默病（AD）的ABATE随机，双盲，安慰剂对照1b/2期临床试验继续完全盲法（NCT05462106）。根据美国国家老年痴呆症协会（NIA-AA）的标准，登记的患者需要诊断为前驱AD:AD引起的MCI，筛查时的PET扫描必须与淀粉样蛋白病理的存在一致。

Patients will be randomized to one of several doses of ACI-24.060 or placebo. Following multiple data safety monitoring board (DSMB) reviews, no safety concerns have been raised to date, consistent with previous results. Immunogenicity of the immunotherapy is very encouraging with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data.

患者将被随机分配到几种剂量的ACI-24.060或安慰剂中的一种。在多次数据安全监测委员会（DSMB）审查之后，迄今为止没有提出任何安全问题，与之前的结果一致。免疫疗法的免疫原性非常令人鼓舞，在盲法数据中观察到针对有毒Abeta物种的抗Abeta抗体反应的明确证据。

The six-month Abeta positron emission tomography (PET) imaging results are expected in Q2 2024, and the 12-month Abeta PET data are expected in Q4 2024..

预计2024年第二季度将有6个月的Abeta正电子发射断层扫描（PET）成像结果，预计2024年第四季度将有12个月的Abeta PET数据。。

About Takeda

关于武田

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

武田致力于为人们创造更好的健康，为世界创造更美好的未来。我们的目标是在我们的核心治疗和业务领域发现并提供改变生命的治疗方法，包括胃肠道和炎症、罕见疾病、血浆衍生疗法、肿瘤学、神经科学和疫苗。

Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet.

与我们的合作伙伴一起，我们的目标是通过我们动态多样的渠道改善患者体验，并推进治疗选择的新前沿。作为总部位于日本的领先的基于价值观、研发驱动的生物制药公司，我们以对患者、人民和地球的承诺为指导。

Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com..

我们在大约80个国家和地区的员工是由我们的目标驱动的，并以两个多世纪以来定义我们的价值观为基础。有关更多信息，请访问www.takeda.com。。

About AC Immune SA

关于AC Immune SA

AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine 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 sixteen therapeutic and diagnostic programs, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3.

AC Immune SA是一家临床阶段的生物制药公司，旨在成为神经退行性疾病（包括阿尔茨海默氏病，帕金森氏病和由错误折叠的蛋白质驱动的神经孤儿适应症）精准医学的全球领导者。该公司的两个经过临床验证的技术平台SupraAntigen®和Morphomer®为其广泛多样的一流和一流资产提供了支持，目前拥有16个治疗和诊断计划，其中5个目前处于第二阶段临床试验，其中一个处于第三阶段。

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 >$4.5 billion in potential milestone payments..

AC Immune在与全球领先的制药公司建立战略伙伴关系方面有着良好的记录，因此获得了大量非稀释性资金来推进其专有项目，并获得了超过45亿美元的潜在里程碑付款。。