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
- 协议基于成功的合作，支持制造用于阿尔茨海默病临床研究中的sabirnetug（ACU193）药物物质（DS）
- 扩展提供龙沙位于瑞士维斯普（Visp）提供的药品产品（DP）制造服务，用于临床和潜在的商业供应
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（环球新闻通讯社）--Acumen Pharmaceuticals，Inc.（纳斯达克：ABOS）与瑞士龙沙（Lonza）继续扩展合作，以推动sabirnetug（ACU193）的潜在未来商业上市。Acumen是一家处于临床阶段的生物制药公司，正在研发一种针对毒性可溶性淀粉样蛋白β（Aβ）寡聚体（AβOs）的新型治疗药物，用于治疗阿尔茨海默病（AD），宣布今天已与Lonza扩展合作。
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是第一种已在AD患者中临床证明具有选择性靶点结合能力的人源化单克隆抗体。可溶性AβOs是Aβ的一种高度毒性形式，在进行AD的临床诊断之前开始积累，是突触功能异常和神经退行性的早期和持续触发。Acumen将sabirnetug开发为早期AD的潜在下一代抗体治疗。Acumen目前正在进行ALTITUDE sabirnetug -AD研究的受试者招募，这是一项旨在评估静脉给药sabirnetug对早期AD患者临床疗效和安全性的II期临床试验。Acumen还正在进行一项关于健康志愿者的皮下给药sabirnetug的I期药代动力学比较研究。
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.
扩展合作基于两家公司之间现有成功的关系，Lonza为sabirnetug的II期临床供应提供DS制造。根据扩展协议的条款，Lonza将在其位于瑞士维斯普（Visp）的行业领先的最先进的DP制造设施中，为正在进行和未来的临床阶段制造sabirnetug的cGMP DP，并支持潜在的商业上市。龙沙还将作为合作的一部分提供质量控制和稳定性测试。
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."
龙沙制药品务部负责人Peter Droc评论道：“我们的专家团队在支持药物制剂的临床和商业制造方面拥有丰富经验。与我们提供生物制品制造端到端一体化方案的策略一致，我们期待与Acumen合作，推动其创新且有前景的药物候选品在临床及更广泛领域中的发展。”
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制药公司总裁兼首席发展官James Doherty补充说：“我们扩展合作的时机正值我们在美国、加拿大、英国和欧盟范围内启动50多个第2阶段试验点的临床计划时。我们期待继续与龙沙合作，为早期阿尔茨海默病提供潜在的下一代治疗。”
About Sabirnetug (ACU193)
关于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)是一种人源化的单克隆抗体（mAb），基于其选择性针对溶解性淀粉样蛋白β寡聚体（AβOs）而发现和开发，相对于Aβ单体和淀粉样斑块，AβOs是一种高度有毒和致病的Aβ形式。已观察到溶解性AβOs是结合到神经元、抑制突触功能和诱导神经退行性的强有力神经毒素。通过有选择性地针对有毒的溶解性AβOs，Sabirnetug旨在解决溶解性AβOs是阿尔茨海默病神经退行过程的早期和持续潜在根本原因的假设。Sabirnetug已被美国食品药物管理局授予早期阿尔茨海默病治疗的快速通道资格，并目前正在进行针对早期阿尔茨海默病患者的第2阶段研究评估中。
About Acumen Pharmaceuticals, Inc.
世锐制药是一家临床阶段的生物制药公司，开发一种新型治疗方法，针对致毒的可溶性淀粉样蛋白β寡聚体，治疗阿尔茨海默病。世锐制药的创始人在AβOs研究方面走在了前沿，越来越多的证据表明它们是阿尔茨海默病病理过程的早期和持续的触发器。目前，世锐制药专注于推进其研究产品候选Sabirnetug（ACU193）在ALTITUDE-AD（NCT06335173）的第2期临床试验中，治疗早期症状的阿尔茨海默病患者，经过了INTERCEPt-AD的第1期试验的积极结果。公司总部设在马萨诸塞州的纽顿市。
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是一家处于临床阶段的生物制药公司，正在开发一种针对有毒可溶性淀粉样蛋白β寡聚体(AβOs)的新疗法，用于治疗阿尔茨海默病(AD)。Acumen的科学创始人开创了AβOs的研究，越来越多的证据表明AβOs是阿尔茨海默病病理的早期和持续触发因素。Acumen目前专注于推进其研究性产品候选药物sabirnetug (ACU193)的临床二期研究项目ALTITUDE-AD (NCT06335173)，该药是一种人源单克隆抗体，选择性地靶向有毒可溶性AβOs，在其早期症状阿尔茨海默病患者中进行，此前在其一期试验INTERCEPt-AD取得正面效果。该公司总部位于马萨诸塞州牛顿市。更多信息请访问。
Forward-Looking Statements of Acumen Pharmaceuticals
Acumen Pharmaceuticals的前瞻性声明
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.
本新闻稿含有根据《1995年《私人证券诉讼改革法》》的前瞻性声明。任何描述Acumen目标、期望、财务或其他预测、意图或信念的声明均为前瞻性声明，应视为风险声明。"相信"，"期待"，"预见"，"可能"，"应该"，"愿意"，"寻求"，"旨在"，"计划"，"潜力"，"将"，"里程碑"等词汇旨在识别前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词汇。前瞻性声明包括有关Acumen业务和Acumen的产品候选药物sabirnetug (ACU193)治疗潜力的声明，包括与其他抗体的比较。这些声明基于Acumen管理层目前的信念和期望，受到一定因素、风险和不确定性的影响，尤其是在发现、开发和商业化安全有效的人类治疗药物的过程中固有的风险。此类风险可能会因地缘政治事件和宏观经济状况的影响而加剧，例如通胀上升和利率期货、供应中断以及信贷和金融市场的不确定性。与Acumen的项目有关的这些风险在Acumen向美国证券交易委员会（"SEC"）的附加细节文件中描述，包括在Acumen的最新年度报告10-k中，以及随后向SEC提交的文件中。这些文档的副本可从Acumen获得。更多信息将会在Acumen不时向SEC提交的其他申报文件中提供。这些前瞻性声明仅代表发表日期的观点，Acumen明确声明不承担更新或修订任何前瞻性声明的义务，除非受到法律要求，无论是由于新信息、未来事件还是其他原因。
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.
龙沙声明
本媒体公告中讨论的某些事项可能构成前瞻性声明。这些声明基于龙沙集团有限公司当前的期望和估计，尽管龙沙集团有限公司无法保证这些期望和估计会实现。投资者应当注意，所有前瞻性声明都涉及风险和不确定性，并在其全部内容上加以限定。由于各种因素，实际结果可能会与本新闻稿中包含的前瞻性声明在未来有重大差异。此外，除非法律另有规定，龙沙集团有限公司否认在本媒体公告中更新所含声明的任何意图或义务。
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.
所有商标均属于龙沙，并在瑞士，美国和/或欧盟注册，或属于其各自的第三方所有者，仅用于信息目的。
Privacy Policy link
隐私政策链接
Acumen Investors:
Alex Braun
abraun@acumenpharm.com
Acumen投资者:
亚历克斯·布劳恩
abraun@acumenpharm.com
Acumen Media:
Jon Yu
ICR Westwicke
AcumenPR@westwicke.com
Acumen媒体:
Jon Yu
ICR Westwicke
AcumenPR@westwicke.com
Lonza Contact Details:
media@lonza.com
龙沙联系方式:
media@lonza.com
