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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 免疫的 ACI-24.060 抗澱粉樣蛋白 β 疫苗在 1b/2 期 ABATE 試驗中顯示出正面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免疫公司治療阿爾茨海默病的ACI-24.060抗澱粉樣貝塔疫苗呈陽性首字母1b/2期減毒試驗的臨時安全性和免疫原性

  • 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的第一個低劑量隊列中引起抗Aβ抗體應答
  • ACI-24.060一般耐受性良好,沒有觀察到安全問題
  • 有了這些發現,在第二個更高劑量的阿爾茨海默病隊列中的劑量已經開始
  • 唐氏綜合症研究參與者隊列的篩查也將開始
  • 預計2023年下半年減量隊列的進一步安全性和免疫原性研究結果
  • 預計2024年通過PET成像測量的澱粉樣斑塊減少的初始數據

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(納斯達克代碼:ACIU)是一家臨牀階段的生物製藥公司,開創了治療神經退行性疾病的精確藥物。該公司今天宣佈,其抗澱粉樣β蛋白(Abeta)疫苗ACI-24.060在前驅阿爾茨海默病(AD)患者中進行的1b/2階段減效試驗的首箇中期安全性、耐受性和免疫原性研究結果。Abate現在將按計劃擴大到包括唐氏綜合症(DS)的個人,並評估阿爾茨海默氏症患者的更高劑量。

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.

使用抗體靶向Abeta最近已被FDA批准用於AD患者的新的單抗治療而得到驗證。通過激發多克隆抗Abeta抗體,ACI-24.060抗Abeta疫苗開發計劃旨在從潛在的安全性和耐受性、低頻率給藥、低總成本和持久反應等方面最終為患者、他們的照顧者和醫療保健系統帶來顯著好處。

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.

第一個AD患者隊列的早期結果顯示,小劑量的ACI-24.060最早在6周(第二次注射後2周)就能誘導抗Aβ抗體應答。數據顯示,到目前為止,ACI-24.060疫苗接種是安全的,耐受性良好。因此,在ABATE的第二個更高劑量的AD隊列中的劑量現在已經開始,試驗被批准開始為研究的第二部分篩查患有DS的個體。

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免疫公司首席執行官安德里亞·普費弗博士評論説:我們對今天報道的ACI-24.060在ABATE中的初步安全性和免疫原性發現感到高興。我們相信,ACI-24.060的成功開發可以為患者提供一種新的治療選擇,在治療、維護和預防環境中提供許多潛在的優勢。這些來自ABATE的早期發現代表着朝着這一目標邁出的重要一步,我們期待着在未來的會議上報告更詳細的數據。“

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免疫公司首席營銷官約翰尼斯·斯特雷弗評論道:ABATE的創新設計包括臨時的阿貝塔正電子發射計算機斷層掃描成像分析,可以根據通過臨牀驗證的單抗達到的斑塊清除水平作為基準。這將為早期降低ACI-24.060的風險提供機會,並有可能迅速過渡到關鍵計劃。此外,將患有DS的參與者納入試驗中,使我們有可能滿足服務嚴重不足的脆弱人羣的需求,這些人幾乎都將患上澱粉樣斑塊和AD。在期待試驗的持續進展和即將公佈的數據的同時,我想感謝參與者和研究人員的參與和支持。

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.

關於階段1b/2消退學習 (ClinicalTrials.gov標識:NCT05462106)
ABATE試驗是一項1b/2期多中心、適應性、雙盲、隨機、安慰劑對照試驗,旨在評估ACI-24.060在先兆阿爾茨海默病患者和成人唐氏綜合症患者中的安全性、耐受性、免疫原性和藥效學效果。所有參與試驗的人都必須有正電子發射斷層掃描(PET)證實的腦Abeta病理。該試驗以AD患者的劑量遞增階段開始,在此階段可能會評估各種劑量/劑量方案,還包括患有DS的個人。

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.

關於ACI-24.060
ACI-24.060源自AC免疫公司的超抗原®平臺,已在臨牀前研究中被證明可誘導強大的多克隆抗體反應,該抗體反應成熟並可針對寡聚體和焦穀氨酸-Aβ兩種物種維持,這兩種類型的Aβ被認為是推動Aβ斑塊形成和疾病進展的關鍵病理形式。ACI-24.060旨在增強廣譜保護性抗體的形成,具有先前在ACI-24計劃的第一階段和第二階段試驗中證明的相同的安全性和耐受性。這一候選研究具有有效抑制斑塊形成和增加斑塊清除的潛力,從而可能減少或防止疾病進展。

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.

關於AC免疫系統公司
AC免疫公司是一家臨牀階段的生物製藥公司,致力於成為治療神經退行性疾病的全球領先企業,這些疾病包括阿爾茨海默病、帕金森病和由錯誤摺疊的蛋白質導致的神經孤兒症。該公司的兩個經過臨牀驗證的技術平臺--超抗原®和Morphmer®AC免疫公司在與領先的全球製藥公司建立戰略夥伴關係方面有着良好的記錄,這些公司包括羅氏集團的成員基因泰克公司、禮來公司和其他公司,從而為其專利計劃的推進提供了大量的非稀釋資金,並獲得了超過30億美元的潛在里程碑付款。

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免疫公司在下列地區的註冊商標:Au、EU、CH、GB、JP、RU、SG和美國。Morphmer®是AC免疫SA在CN、CH、GB、JP、KR、NO和RU中的註冊商標。

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.

本新聞稿中提及的我們網站和任何其他網站上的信息明確不包含在本新聞稿中作為參考,也不構成本新聞稿的一部分。

For further information, please contact:

如需更多信息,請聯繫:

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
 
首席執行官投資者關係&企業通信
加里·萬德斯,博士,MBA
交流免疫
電話:+41 21 345 91 91
電子郵件:gary.waanders@acmune.com
美國投資者
科裏·戴維斯博士。
LifeSci顧問
電話:+12129152577
電子郵件:cdavis@lifescivisors.com
國際媒體
克里斯·馬戈斯
凝聚力局
電話:+41793676254
電子郵件: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.

前瞻性陳述
本新聞稿包含1933年證券法第27A節和1934年證券交易法第21E節所指的“前瞻性陳述”。前瞻性陳述是與歷史事實無關的陳述,可能包括涉及未來經營、財務或業務表現或AC免疫公司的戰略或預期的陳述。在某些情況下,您可以通過“可能”、“可能”、“將”、“應該”、“預期”、“計劃”、“預期”、“相信”、“估計”、“預測”、“項目”、“潛在”、“展望”或“繼續”等前瞻性詞彙來識別這些陳述。前瞻性陳述基於管理層目前的預期和信念,涉及重大風險和不確定因素,可能導致實際結果、發展和業務決策與這些陳述所預期的大不相同。這些風險和不確定因素包括在AC免疫公司的20-F表格年度報告和其他提交給證券交易委員會的文件中的標題“第3項.關鍵信息--風險因素”和“第5項.經營和財務回顧及前景”中描述的那些風險和不確定因素。這些包括:新冠肺炎對我們的業務、供應商、患者和員工的影響以及新冠肺炎的任何其他影響。前瞻性聲明僅在發佈之日發表,AC免疫公司不承擔根據新信息、未來發展或其他情況更新這些聲明的任何義務,除非適用法律可能要求這樣做。所有前瞻性陳述均受本警告性聲明的限制。

Attachment

依附

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

譯文內容由第三人軟體翻譯。


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