Acumen Pharmaceuticals Collaborates with Lonza to Advance Sabirnetug for the Treatment of Alzheimer’s Disease
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The partnership between Acumen Pharmaceuticals and Lonza indicates a strategic maneuver within the biotechnology sector, specifically in the development of therapeutics for Alzheimer's disease. The focus on monoclonal antibody technology, exemplified by sabirnetug, represents an innovative approach targeting amyloid beta oligomers, a key factor implicated in the pathogenesis of Alzheimer's. The manufacturing capabilities of Lonza, particularly the use of 2,000L single-use bioreactors, are significant as they offer scalability and flexibility in production, which is essential for meeting potential commercial demand.
From a financial perspective, the collaboration could have implications for the valuation of both companies. For Acumen, securing a manufacturing agreement with a reputable partner like Lonza may enhance investor confidence in the company's ability to deliver its product to market, should clinical trials prove successful. On the other hand, Lonza stands to benefit from expanding its portfolio of manufacturing contracts, which can contribute to steady revenue streams and diversification of risk.
The advancement of sabirnetug into Phase 2 clinical trials is a pivotal stage in its development. The success of Phase 1 trials, demonstrating selective engagement with amyloid beta oligomers, suggests potential efficacy in modifying the course of Alzheimer's disease. Phase 2 will be critical in evaluating the safety and effectiveness of the drug in a larger cohort, providing more substantial evidence for its therapeutic value. The ability of sabirnetug to prevent the binding of toxic oligomers to neurons could be a breakthrough in preserving cognitive function in patients, addressing an unmet medical need.
However, the Alzheimer's drug development landscape is fraught with challenges, as many promising candidates have failed in late-stage trials. It is important for stakeholders to remain cautious and for Acumen to continue demonstrating robust, reproducible results. The partnership with Lonza may also be seen as a preparatory step for potential commercialization, indicating Acumen's optimism in sabirnetug's prospects.
Lonza's next-generation, single-use bioreactor technology is a noteworthy aspect of this collaboration. Single-use systems are increasingly favored in biopharmaceutical manufacturing due to their reduced risk of cross-contamination, decreased setup times and lower requirements for cleaning and validation. This technology aligns with industry trends towards more efficient, flexible and scalable production methods. The capacity range from 2,000L to 20,000L also suggests that Lonza is well-equipped to support Acumen from clinical trials through to potential commercial-scale production.
The emphasis on cGMP (current Good Manufacturing Practice) compliance is crucial, as it ensures the drug substance is produced to the highest quality standards required for regulatory approval and patient safety. The expertise of Lonza in regulatory affairs could be a strategic advantage for Acumen, as navigating the complex regulatory landscape is often a significant hurdle for biotech companies. Their combined efforts could expedite the time-to-market for sabirnetug, pending successful trial outcomes.
- Lonza to manufacture Acumen’s monoclonal antibody, sabirnetug (ACU193), for clinical development and commercialization, if approved
- Sabirnetug is the first monoclonal antibody candidate to enter the clinic developed to selectively target toxic soluble amyloid beta oligomers, which evidence indicates are a primary underlying cause of Alzheimer’s disease (AD)
- Acumen is on track to initiate a Phase 2 clinical trial evaluating sabirnetug in the first half of 2024
CHARLOTTESVILLE, Va. and BASEL, Switzerland, April 04, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, 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), has signed a collaboration agreement with Lonza, a global partner to the pharmaceutical, biotech and nutraceutical markets. The agreement covers the manufacture of sabirnetug (ACU193), an antibody targeting toxic soluble AβOs for the treatment of AD, for clinical development and commercialization, if approved.
Under the terms of the agreement, Lonza will manufacture the sabirnetug drug substance at its next-generation, manufacturing facility in Portsmouth, New Hampshire (US), equipped with 2,000L single-use bioreactors. Acumen will leverage Lonza’s regulatory expertise, extensive experience in antibody manufacturing, and global manufacturing network from 2,000L to 20,000L.
Sabirnetug is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs in a Phase 1 first-in-human study. As AβOs are an early trigger and persistent driver of Alzheimer’s-associated synaptic dysfunction and neurodegeneration, sabirnetug addresses an underlying cause of Alzheimer’s by preventing toxic AβOs from binding to dendritic spines and by preserving neuronal function.
Stefan Egli, Global Head of Mammalian Biologics, Lonza, commented: “Our collaboration with Acumen showcases our flexibility in enabling innovative biotech companies to advance their innovative therapies on accelerated timelines. We are excited that our new, next-generation single-use manufacturing facility in Portsmouth (US) will be used to manufacture a cGMP drug substance that could bring new treatment options to patients suffering from Alzheimer’s disease.”
James Doherty, President and Chief Development Officer, Acumen Pharmaceuticals, added: “As we progress into Phase 2 clinical development of sabirnetug as a potentially best-in-class treatment for early AD, we are acutely aware that patients and their families are in urgent need of safe, effective treatment options for this devastating disease. Partnering with Lonza is a critical step to ensure broader access to next-generation AD therapies.”
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA, with additional offices in Indianapolis, IN and Newton, MA, 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, following positive results in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients. For more information, visit www.acumenpharm.com.
About Lonza
Lonza is one of the world’s largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments.
Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of CHF 6.7 billion with a CORE EBITDA of CHF 2.0 billion in Full-Year 2023. Find out more at www.lonza.com.
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Forward-Looking Statements of Acumen Pharmaceuticals
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 “potential,” “will” 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 the therapeutic potential and manufacturing of Acumen’s product candidate, sabirnetug (ACU193), Acumen’s preparations with respect to its plans to initiate a Phase 2 study, and Acumen’s ability and expectations to receive regulatory approval for and bring ACU193 to patients living with AD. These statements are based upon the current beliefs and expectations of Acumen’s 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, 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.
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.
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