Acumen Pharmaceuticals Extends Collaboration With Lonza to Add Drug Product Manufacturing of Sabirnetug for Early Alzheimer's Disease
Acumen Pharmaceuticals Extends Collaboration With Lonza to Add Drug Product Manufacturing of Sabirnetug for Early Alzheimer's Disease
- Agreement builds upon a successful collaboration supporting the manufacture of sabirnetug (ACU193) drug substance (DS) for clinical studies in Alzheimer's disease
- Extension to provide drug product (DP) manufacturing services for clinical and potential commercial supply from Lonza's Visp, Switzerland site
- 協議基於成功的合作，支持製造用於阿爾茨海默病臨床研究中的sabirnetug（ACU193）藥物物質（DS）
- 擴展提供龍沙位於瑞士維斯普（Visp）提供的藥品產品（DP）製造服務，用於臨床和潛在的商業供應
NEWTON, Mass., and BASEL, Switzerland, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta (Aβ) oligomers (AβOs) for the treatment of Alzheimer's disease (AD), announced today that it has extended its collaboration with Lonza to enable the potential future commercial launch of sabirnetug (ACU193).
2024年9月26日（環球新聞通訊社）--Acumen Pharmaceuticals，Inc.（納斯達克：ABOS）與瑞士龍沙（Lonza）繼續擴展合作，以推動sabirnetug（ACU193）的潛在未來商業上市。Acumen是一家處於臨床階段的生物製藥公司，正在研發一種針對毒性可溶性澱粉樣蛋白β（Aβ）寡聚體（AβOs）的新型治療藥物，用於治療阿爾茨海默病（AD），宣佈今天已與Lonza擴展合作。
Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in AD patients. Soluble AβOs are a highly toxic form of Aβ that begin to accumulate before a clinical diagnosis of AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential next generation antibody treatment for early AD. Acumen is currently enrolling patients in the ALTITUDE sabirnetug -AD study, a Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of intravenous sabirnetug in patients with early AD. Acumen is also evaluating a subcutaneous formulation of sabirnetug in a Phase 1 pharmacokinetic comparison study in healthy volunteers.
sabirnetug是第一種已在AD患者中臨床證明具有選擇性靶點結合能力的人源化單克隆抗體。可溶性AβOs是Aβ的一種高度毒性形式，在進行AD的臨床診斷之前開始積累，是突觸功能異常和神經退行性的早期和持續觸發。Acumen將sabirnetug開發爲早期AD的潛在下一代抗體治療。Acumen目前正在進行ALTITUDE sabirnetug -AD研究的受試者招募，這是一項旨在評估靜脈給藥sabirnetug對早期AD患者臨床療效和安全性的II期臨床試驗。Acumen還正在進行一項關於健康志願者的皮下給藥sabirnetug的I期藥代動力學比較研究。
The extended collaboration builds upon an existing successful relationship between the two companies, in which Lonza provides DS manufacturing for the Phase 2 clinical supply of sabirnetug. Under the terms of the extended agreement, Lonza will manufacture cGMP DP of sabirnetug for the ongoing and future clinical phases and support the potential commercial launch at its industry-leading state-of-the-art DP manufacturing facility in Visp, Switzerland. Lonza will also provide quality control and stability testing as part of the collaboration.
擴展合作基於兩家公司之間現有成功的關係，Lonza爲sabirnetug的II期臨床供應提供DS製造。根據擴展協議的條款，Lonza將在其位於瑞士維斯普（Visp）的行業領先的最先進的DP製造設施中，爲正在進行和未來的臨床階段製造sabirnetug的cGMP DP，並支持潛在的商業上市。龍沙還將作爲合作的一部分提供質量控制和穩定性測試。
Peter Droc, Head of Drug Product Services, Lonza, commented: "Our team of experts has extensive experience in supporting the clinical and commercial manufacture of drug products. In line with our strategy to offer an integrated end-to-end offering for biologics manufacturing, we are looking forward to collaborating with Acumen to advance its innovative and promising drug candidate in the clinic and beyond."
龍沙製藥品務部負責人Peter Droc評論道：「我們的專家團隊在支持藥物製劑的臨床和商業製造方面擁有豐富經驗。與我們提供生物製品製造端到端一體化方案的策略一致，我們期待與Acumen合作，推動其創新且有前景的藥物候選品在臨床及更廣泛領域中的發展。」
James Doherty, President and Chief Development Officer, Acumen Pharmaceuticals, added: "The extension of our collaboration comes at a time when we're advancing our clinical programs for sabirnetug with more than 50 Phase 2 sites activated across the U.S., Canada, U.K. and EU. We look forward to continuing our work with Lonza and delivering a potential next-generation treatment for early Alzheimer's disease."
Acumen製藥公司總裁兼首席發展官James Doherty補充說：「我們擴展合作的時機正值我們在美國、加拿大、英國和歐盟範圍內啓動50多個第2階段試驗點的臨床計劃時。我們期待繼續與龍沙合作，爲早期阿爾茨海默病提供潛在的下一代治療。」
About Sabirnetug (ACU193)
關於Sabirnetug（ACU193）
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer's disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.
Sabirnetug (ACU193)是一種人源化的單克隆抗體（mAb），基於其選擇性針對溶解性澱粉樣蛋白β寡聚體（AβOs）而發現和開發，相對於Aβ單體和澱粉樣斑塊，AβOs是一種高度有毒和致病的Aβ形式。已觀察到溶解性AβOs是結合到神經元、抑制突觸功能和誘導神經退行性的強有力神經毒素。通過有選擇性地針對有毒的溶解性AβOs，Sabirnetug旨在解決溶解性AβOs是阿爾茨海默病神經退行過程的早期和持續潛在根本原因的假設。Sabirnetug已被美國食品藥物管理局授予早期阿爾茨海默病治療的快速通道資格，並目前正在進行鍼對早期阿爾茨海默病患者的第2階段研究評估中。
About Acumen Pharmaceuticals, Inc.
世銳製藥是一家臨床階段的生物製藥公司，開發一種新型治療方法，針對致毒的可溶性澱粉樣蛋白β寡聚體，治療阿爾茨海默病。世銳製藥的創始人在AβOs研究方面走在了前沿，越來越多的證據表明它們是阿爾茨海默病病理過程的早期和持續的觸發器。目前，世銳製藥專注於推進其研究產品候選Sabirnetug（ACU193）在ALTITUDE-AD（NCT06335173）的第2期臨床試驗中，治療早期症狀的阿爾茨海默病患者，經過了INTERCEPt-AD的第1期試驗的積極結果。公司總部設在馬薩諸塞州的紐頓市。
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer's disease (AD). Acumen's scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer's disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer's disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit .
Acumen Pharmaceuticals是一家處於臨床階段的生物製藥公司，正在開發一種針對有毒可溶性澱粉樣蛋白β寡聚體(AβOs)的新療法，用於治療阿爾茨海默病(AD)。Acumen的科學創始人開創了AβOs的研究，越來越多的證據表明AβOs是阿爾茨海默病病理的早期和持續觸發因素。Acumen目前專注於推進其研究性產品候選藥物sabirnetug (ACU193)的臨床二期研究項目ALTITUDE-AD (NCT06335173)，該藥是一種人源單克隆抗體，選擇性地靶向有毒可溶性AβOs，在其早期症狀阿爾茨海默病患者中進行，此前在其一期試驗INTERCEPt-AD取得正面效果。該公司總部位於馬薩諸塞州牛頓市。更多信息請訪問。
Forward-Looking Statements of Acumen Pharmaceuticals
Acumen Pharmaceuticals的前瞻性聲明
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen's goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as "believes," "expects," "anticipates," "could," "should," "would," "seeks," "aims," "plans," "potential," "will," "milestone" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning Acumen's business, and the therapeutic potential of Acumen's product candidate, sabirnetug (ACU193), including against other antibodies. These statements are based upon the current beliefs and expectations of Acumen management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen's programs are described in additional detail in Acumen's filings with the Securities and Exchange Commission ("SEC"), including in Acumen's most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.
本新聞稿含有根據《1995年《私人證券訴訟改革法》》的前瞻性聲明。任何描述Acumen目標、期望、財務或其他預測、意圖或信念的聲明均爲前瞻性聲明，應視爲風險聲明。"相信"，"期待"，"預見"，"可能"，"應該"，"願意"，"尋求"，"旨在"，"計劃"，"潛力"，"將"，"里程碑"等詞彙旨在識別前瞻性聲明，儘管並非所有前瞻性聲明都包含這些識別詞彙。前瞻性聲明包括有關Acumen業務和Acumen的產品候選藥物sabirnetug (ACU193)治療潛力的聲明，包括與其他抗體的比較。這些聲明基於Acumen管理層目前的信念和期望，受到一定因素、風險和不確定性的影響，尤其是在發現、開發和商業化安全有效的人類治療藥物的過程中固有的風險。此類風險可能會因地緣政治事件和宏觀經濟狀況的影響而加劇，例如通脹上升和利率期貨、供應中斷以及信貸和金融市場的不確定性。與Acumen的項目有關的這些風險在Acumen向美國證券交易委員會（"SEC"）的附加細節文件中描述，包括在Acumen的最新年度報告10-k中，以及隨後向SEC提交的文件中。這些文檔的副本可從Acumen獲得。更多信息將會在Acumen不時向SEC提交的其他申報文件中提供。這些前瞻性聲明僅代表發表日期的觀點，Acumen明確聲明不承擔更新或修訂任何前瞻性聲明的義務，除非受到法律要求，無論是由於新信息、未來事件還是其他原因。
Disclaimer of Lonza
Certain matters discussed in this media advisory may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this media advisory.
龍沙聲明
本媒體公告中討論的某些事項可能構成前瞻性聲明。這些聲明基於龍沙集團有限公司當前的期望和估計，儘管龍沙集團有限公司無法保證這些期望和估計會實現。投資者應當注意，所有前瞻性聲明都涉及風險和不確定性，並在其全部內容上加以限定。由於各種因素，實際結果可能會與本新聞稿中包含的前瞻性聲明在未來有重大差異。此外，除非法律另有規定，龍沙集團有限公司否認在本媒體公告中更新所含聲明的任何意圖或義務。
All trademarks belong to Lonza and are registered in CH, US and/or EU, or belong to their respective third party owners and are used only for informational purposes.
所有商標均屬於龍沙，並在瑞士，美國和/或歐盟註冊，或屬於其各自的第三方所有者，僅用於信息目的。
Privacy Policy link
隱私政策鏈接
Acumen Investors:
Alex Braun
abraun@acumenpharm.com
Acumen投資者:
亞歷克斯·布勞恩
abraun@acumenpharm.com
Acumen Media:
Jon Yu
ICR Westwicke
AcumenPR@westwicke.com
Acumen媒體:
Jon Yu
ICR Westwicke
AcumenPR@westwicke.com
Lonza Contact Details:
media@lonza.com
龍沙聯繫方式:
media@lonza.com
譯文內容由第三人軟體翻譯。
