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AC Immune’s ACI-24.060 Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial

AC Immune’s ACI-24.060 Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial

AC Immune 的 ACI-24.060 针对阿尔茨海默氏症的 ACI-24.060 抗淀粉样蛋白 β 疫苗在 1b/2 ABATE 期试验中显示出积极的初始中期安全性和免疫原性
GlobeNewswire ·  2023/01/26 20:06

AC Immune's ACI-24.060 Anti-Amyloid Beta Vaccine for Alzheimer's Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial

AC免疫公司治疗阿尔茨海默病的ACI-24.060抗淀粉样贝塔疫苗呈阳性首字母1b/2期减毒试验的临时安全性和免疫原性

  • ACI-24.060 elicited an anti-Abeta antibody response in ABATE's first, low dose cohort
  • ACI-24.060 was generally well tolerated with no safety concerns observed
  • With these findings, dosing in the second, higher dose Alzheimer's cohort has begun
  • Screening of cohort of study participants with Down syndrome also cleared to begin
  • Further safety and immunogenicity findings from ABATE cohorts expected in H2 2023
  • Initial data on amyloid plaque reduction measured via PET imaging anticipated in 2024
  • ACI-24.060在ABATE的第一个低剂量队列中引起抗Aβ抗体应答
  • ACI-24.060一般耐受性良好,没有观察到安全问题
  • 有了这些发现,在第二个更高剂量的阿尔茨海默病队列中的剂量已经开始
  • 唐氏综合症研究参与者队列的筛查也将开始
  • 预计2023年下半年减量队列的进一步安全性和免疫原性研究结果
  • 预计2024年通过PET成像测量的淀粉样斑块减少的初始数据

Lausanne, Switzerland, January 26, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced the first interim safety, tolerability and immunogenicity findings from the Phase 1b/2 ABATE trial of its anti-amyloid-beta (Abeta) vaccine ACI-24.060 in patients with prodromal Alzheimer's disease (AD). ABATE will now be expanded, as planned, to include individuals with Down syndrome (DS) and to evaluate higher doses in Alzheimer's patients.

瑞士洛桑, 一月 26, 2023-AC免疫公司(纳斯达克代码:ACIU)是一家临床阶段的生物制药公司,开创了治疗神经退行性疾病的精确药物。该公司今天宣布,其抗淀粉样β蛋白(Abeta)疫苗ACI-24.060在前驱阿尔茨海默病(AD)患者中进行的1b/2阶段减效试验的首个中期安全性、耐受性和免疫原性研究结果。Abate现在将按计划扩大到包括唐氏综合症(DS)的个人,并评估阿尔茨海默氏症患者的更高剂量。

Targeting Abeta using antibodies has recently been validated with FDA approvals of new monoclonal antibody treatments for patients with AD. By eliciting polyclonal anti-Abeta antibodies, the ACI-24.060 anti-Abeta vaccine development program aims to ultimately deliver significant benefits to patients, their caregivers, and healthcare systems in terms of potential safety and tolerability, low frequency dosing, low overall costs and durable responses.

使用抗体靶向Abeta最近已被FDA批准用于AD患者的新的单抗治疗而得到验证。通过激发多克隆抗Abeta抗体,ACI-24.060抗Abeta疫苗开发计划旨在从潜在的安全性和耐受性、低频率给药、低总成本和持久反应等方面最终为患者、他们的照顾者和医疗保健系统带来显著好处。

Early results from the first cohort of AD patients in ABATE showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection). The data show that ACI-24.060 vaccination has been safe and well tolerated to date. As a result, dosing in ABATE's second, higher dose AD cohort has now begun and the trial is cleared to begin screening individuals with DS for part 2 of the study.

第一个AD患者队列的早期结果显示,小剂量的ACI-24.060最早在6周(第二次注射后2周)就能诱导抗Aβ抗体应答。数据显示,到目前为止,ACI-24.060疫苗接种是安全的,耐受性良好。因此,在ABATE的第二个更高剂量的AD队列中的剂量现在已经开始,试验被批准开始为研究的第二部分筛查患有DS的个体。

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are delighted with the encouraging initial safety and immunogenicity findings for ACI-24.060 in ABATE reported today. We believe ACI-24.060's successful development could provide patients with a novel therapeutic option offering numerous potential advantages in treatment, maintenance, and prevention settings. These early findings from ABATE represent an important step towards this goal, and we look forward to reporting more detailed data at a future conference."

AC免疫公司首席执行官安德里亚·普费弗博士评论说:我们对今天报道的ACI-24.060在ABATE中的初步安全性和免疫原性发现感到高兴。我们相信,ACI-24.060的成功开发可以为患者提供一种新的治疗选择,在治疗、维护和预防环境中提供许多潜在的优势。这些来自ABATE的早期发现代表着朝着这一目标迈出的重要一步,我们期待着在未来的会议上报告更详细的数据。“

Dr. Johannes Streffer, CMO of AC Immune SA, commented: "ABATE's innovative design includes interim Abeta PET imaging analyses that can be benchmarked against the levels of plaque clearance achieved with clinically-validated monoclonal antibodies. This will provide an opportunity for early de-risking of ACI-24.060 and potentially a rapid transition to a pivotal program. Moreover, the inclusion of cohorts of participants with DS in the trial positions us to potentially address the needs of a vastly underserved vulnerable population, virtually all of whom will develop amyloid plaques and AD. While looking forward to the trial's continued advancement and upcoming data readouts, I want to thank the participants and investigators for their participation and support."

博士。AC免疫公司首席营销官约翰尼斯·斯特雷弗评论道:ABATE的创新设计包括临时的阿贝塔正电子发射计算机断层扫描成像分析,可以根据通过临床验证的单抗达到的斑块清除水平作为基准。这将为早期降低ACI-24.060的风险提供机会,并有可能迅速过渡到关键计划。此外,将患有DS的参与者纳入试验中,使我们有可能满足服务严重不足的脆弱人群的需求,这些人几乎都将患上淀粉样斑块和AD。在期待试验的持续进展和即将公布的数据的同时,我想感谢参与者和研究人员的参与和支持。

About the Phase 1b/2 ABATE Study (ClinicalTrials.gov Identifier: NCT05462106)
The ABATE study is a Phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in adults with Down syndrome. All participants in the trial must have brain Abeta pathology confirmed by a positron emission tomography (PET) scan. The trial begins with a dose escalation phase in AD patients, during which various doses/dosing regimens may be evaluated, and also includes individuals with DS.

关于阶段1b/2消退学习 (ClinicalTrials.gov标识:NCT05462106)
ABATE试验是一项1b/2期多中心、适应性、双盲、随机、安慰剂对照试验,旨在评估ACI-24.060在先兆阿尔茨海默病患者和成人唐氏综合症患者中的安全性、耐受性、免疫原性和药效学效果。所有参与试验的人都必须有正电子发射断层扫描(PET)证实的脑Abeta病理。该试验以AD患者的剂量递增阶段开始,在此阶段可能会评估各种剂量/剂量方案,还包括患有DS的个人。

About ACI-24.060
ACI-24.060, derived from AC Immune's SupraAntigen® platform, has been shown in preclinical studies to induce a strong polyclonal antibody response that matures and is maintained against both oligomeric and pyroglutamate-Abeta species, key pathological forms of Abeta believed to drive Abeta plaque formation and disease progression. ACI-24.060 is designed to enhance the formation of broad-spectrum protective antibodies with the same safety and tolerability previously demonstrated in the ACI-24 program in Phase 1 and 2 trials. This investigational candidate has the potential to efficiently inhibit plaque formation and increase plaque clearance, and thereby may reduce or prevent disease progression.

关于ACI-24.060
ACI-24.060源自AC免疫公司的超抗原®平台,已在临床前研究中被证明可诱导强大的多克隆抗体反应,该抗体反应成熟并可针对寡聚体和焦谷氨酸-Aβ两种物种维持,这两种类型的Aβ被认为是推动Aβ斑块形成和疾病进展的关键病理形式。ACI-24.060旨在增强广谱保护性抗体的形成,具有先前在ACI-24计划的第一阶段和第二阶段试验中证明的相同的安全性和耐受性。这一候选研究具有有效抑制斑块形成和增加斑块清除的潜力,从而可能减少或防止疾病进展。

About 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 ten therapeutic and three diagnostic candidates, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

关于AC免疫系统公司
AC免疫公司是一家临床阶段的生物制药公司,致力于成为治疗神经退行性疾病的全球领先企业,这些疾病包括阿尔茨海默病、帕金森病和由错误折叠的蛋白质导致的神经孤儿症。该公司的两个经过临床验证的技术平台--超抗原®和Morphmer®AC免疫公司在与领先的全球制药公司建立战略伙伴关系方面有着良好的记录,这些公司包括罗氏集团的成员基因泰克公司、礼来公司和其他公司,从而为其专利计划的推进提供了大量的非稀释资金,并获得了超过30亿美元的潜在里程碑付款。

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 CN, CH, GB, JP, KR, NO and RU.

超抗原®是AC免疫公司在下列地区的注册商标:Au、EU、CH、GB、JP、RU、SG和美国。Morphmer®是AC免疫SA在CN、CH、GB、JP、KR、NO和RU中的注册商标。

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.

本新闻稿中提及的我们网站和任何其他网站上的信息明确不包含在本新闻稿中作为参考,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:

Head of Investor Relations & Corporate Communications
Gary Waanders, Ph.D., MBA
AC Immune
Phone: +41 21 345 91 91
Email: gary.waanders@acimmune.com
U.S. Investors
Corey Davis, Ph.D.
LifeSci Advisors
Phone: +1 212 915 2577
Email: cdavis@lifesciadvisors.com
International Media
Chris Maggos
Cohesion Bureau
Phone: +41 79 367 6254
Email: chris.maggos@cohesionbureau.com
 
首席执行官投资者关系&企业通信
加里·万德斯,博士,MBA
交流免疫
电话:+41 21 345 91 91
电子邮件:gary.waanders@acmune.com
美国投资者
科里·戴维斯博士。
LifeSci顾问
电话:+12129152577
电子邮件:cdavis@lifescivisors.com
国际媒体
克里斯·马戈斯
凝聚力局
电话:+41793676254
电子邮件:chris.maggos@Cohesion IBUAU.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.

前瞻性陈述
本新闻稿包含1933年证券法第27A节和1934年证券交易法第21E节所指的“前瞻性陈述”。前瞻性陈述是与历史事实无关的陈述,可能包括涉及未来经营、财务或业务表现或AC免疫公司的战略或预期的陈述。在某些情况下,您可以通过“可能”、“可能”、“将”、“应该”、“预期”、“计划”、“预期”、“相信”、“估计”、“预测”、“项目”、“潜在”、“展望”或“继续”等前瞻性词汇来识别这些陈述。前瞻性陈述基于管理层目前的预期和信念,涉及重大风险和不确定因素,可能导致实际结果、发展和业务决策与这些陈述所预期的大不相同。这些风险和不确定因素包括在AC免疫公司的20-F表格年度报告和其他提交给证券交易委员会的文件中的标题“第3项.关键信息--风险因素”和“第5项.经营和财务回顾及前景”中描述的那些风险和不确定因素。这些包括:新冠肺炎对我们的业务、供应商、患者和员工的影响以及新冠肺炎的任何其他影响。前瞻性声明仅在发布之日发表,AC免疫公司不承担根据新信息、未来发展或其他情况更新这些声明的任何义务,除非适用法律可能要求这样做。所有前瞻性陈述均受本警告性声明的限制。

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  • 20230126_ACIU_ACI-24.060_Initial_Interim-data-FINAL
  • 20230126_ACIU_ACI-24.060_Initial_Interim-data-FINAL

译文内容由第三方软件翻译。


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