Acumen Pharmaceuticals Extends Collaboration with Lonza to Add Drug Product Manufacturing of Sabirnetug for Early Alzheimer’s Disease
Acumen Pharmaceuticals (NASDAQ: ABOS) has extended its collaboration with Lonza to support the potential future commercial launch of sabirnetug (ACU193), a novel therapeutic targeting toxic soluble amyloid beta oligomers for early Alzheimer's disease treatment. The extended agreement builds upon their existing partnership for drug substance manufacturing and now includes drug product manufacturing services at Lonza's Visp, Switzerland site.
Sabirnetug, currently in Phase 2 clinical trials, is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs in Alzheimer's patients. Acumen is also evaluating a subcutaneous formulation in a Phase 1 study. The collaboration extension comes as Acumen advances its clinical programs with over 50 Phase 2 sites activated across the U.S., Canada, U.K. and EU.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha esteso la sua collaborazione con Lonza per supportare il potenziale lancio commerciale futuro di sabirnetug (ACU193), una nuova terapia mirata agli oligomeri di beta-amiloide solubili tossici per il trattamento precoce dell'Alzheimer. L'accordo esteso si basa sulla loro partnership esistente per la produzione della sostanza farmaceutica e ora include anche servizi di produzione del prodotto farmaceutico presso il sito di Lonza a Visp, in Svizzera.
Sabirnetug, attualmente in fase 2 di studi clinici, è il primo anticorpo monoclonale umanizzato a dimostrare un impegno selettivo verso gli AβOs nei pazienti con Alzheimer. Acumen sta anche valutando una formulazione sottocutanea in uno studio di fase 1. L'estensione della collaborazione avviene mentre Acumen avanza i suoi programmi clinici con oltre 50 siti di fase 2 attivati negli Stati Uniti, Canada, Regno Unito e UE.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha ampliado su colaboración con Lonza para apoyar el potencial lanzamiento comercial futuro de sabirnetug (ACU193), una nueva terapia dirigida a los oligómeros de beta-amiloide solubles tóxicos para el tratamiento temprano de la enfermedad de Alzheimer. El acuerdo ampliado se basa en su asociación existente para la fabricación de sustancias activas y ahora incluye también servicios de fabricación de productos farmacéuticos en el sitio de Lonza en Visp, Suiza.
Sabirnetug, actualmente en ensayos clínicos de fase 2, es el primer anticuerpo monoclonal humanizado que demuestra un compromiso selectivo con los AβOs en pacientes con Alzheimer. Acumen también está evaluando una formulación subcutánea en un estudio de fase 1. La extensión de la colaboración se produce mientras Acumen avanza en sus programas clínicos con más de 50 sitios de fase 2 activados en EE.UU., Canadá, Reino Unido y UE.
Acumen Pharmaceuticals (NASDAQ: ABOS)는 Lonza와의 협력을 연장했다며, sabirnetug (ACU193)의 잠재적 상용화 출시를 지원하기 위해 노력하고 있다. 이는 독성 솔블 아밀로이드 베타 올리고머를 타겟으로 하는 새로운 치료제이며, 초기 알츠하이머병 치료에 사용된다. 연장된 계약은 약물 제조를 위한 기존 파트너십을 바탕으로 하며 이제 Lonza의 스위스 비스프에서 약물 제품 제조 서비스도 포함된다.
현재 2상 임상시험 중인 sabirnetug는 알츠하이머 환자에서 AβOs에 대해 선택적으로 작용하는 첫 번째 인간화된 단일클론 항체이다. Acumen은 1상 연구에서 피하 제형도 평가하고 있다. 협력 연장은 Acumen이 미국, 캐나다, 영국 및 EU 전역에서 50개 이상의 2상 사이트를 활성화하면서 이뤄진 것이다.
Acumen Pharmaceuticals (NASDAQ: ABOS) a étendu sa collaboration avec Lonza pour soutenir le lancement commercial potentiel futur de sabirnetug (ACU193), une nouvelle thérapie ciblant les oligomères de bêta-amyloïde solubles toxiques pour le traitement précoce de la maladie d'Alzheimer. L'accord étendu s'appuie sur leur partenariat existant pour la fabrication de substances médicamenteuses et inclut désormais également des services de fabrication de produits pharmaceutiques sur le site de Lonza à Visp, en Suisse.
Sabirnetug, actuellement en essais cliniques de phase 2, est le premier anticorps monoclonal humanisé à montrer un engagement sélectif envers les AβOs chez les patients atteints d'Alzheimer. Acumen évalue également une formulation sous-cutanée dans une étude de phase 1. L'extension de la collaboration intervient alors qu'Acumen fait progresser ses programmes cliniques avec plus de 50 sites de phase 2 activés aux États-Unis, au Canada, au Royaume-Uni et dans l'UE.
Acumen Pharmaceuticals (NASDAQ: ABOS) hat seine Zusammenarbeit mit Lonza erweitert, um die potenzielle kommerzielle Einführung von sabirnetug (ACU193) zu unterstützen, einer neuartigen Therapie, die sich gegen toxische lösliche Amyloid-Beta-Oligomere richtet für die frühe Behandlung von Alzheimer. Die erweiterte Vereinbarung basiert auf ihrer bestehenden Partnerschaft zur Herstellung von Arzneimitteln und umfasst nun auch Herstellungsdienstleistungen für Arzneimittelprodukte am Standort von Lonza in Visp, Schweiz.
Sabirnetug, das sich derzeit in Phase 2 klinischer Studien befindet, ist der erste humanisierte monoklonale Antikörper, der in der Lage ist, selektiv an AβOs bei Alzheimer-Patienten zu binden. Acumen bewertet auch eine subkutane Formulierung in einer Studie der Phase 1. Die Erweiterung der Zusammenarbeit erfolgt, während Acumen seine klinischen Programme mit über 50 aktivierten Phase-2-Standorten in den USA, Kanada, Großbritannien und der EU vorantreibt.
- Extended collaboration with Lonza for potential commercial launch of sabirnetug
- Expansion of manufacturing services to include drug product in addition to drug substance
- Advancement of clinical programs with over 50 Phase 2 sites activated across multiple countries
- Evaluation of both intravenous and subcutaneous formulations of sabirnetug
- None.
Insights
This collaboration extension between Acumen Pharmaceuticals and Lonza is a significant development for ABOS. It demonstrates progress in their clinical pipeline and preparation for potential commercialization of sabirnetug (ACU193) for early Alzheimer's disease.
Key points:
- Expanded partnership now includes drug product (DP) manufacturing, in addition to existing drug substance (DS) production.
- Lonza will provide cGMP DP manufacturing for ongoing and future clinical phases, as well as potential commercial launch.
- The agreement supports Acumen's Phase 2 ALTITUDE study and Phase 1 subcutaneous formulation study.
- Over 50 Phase 2 sites have been activated across multiple countries, indicating significant clinical progress.
This news suggests ABOS is positioning itself for potential future success if clinical trials yield positive results. However, investors should note that Alzheimer's treatments have historically faced challenges in late-stage trials and regulatory approvals. The
Sabirnetug (ACU193) represents an innovative approach in Alzheimer's disease (AD) treatment by targeting toxic soluble amyloid beta oligomers (AβOs). This strategy differentiates it from previous antibodies that primarily targeted amyloid plaques.
Significant aspects:
- First humanized monoclonal antibody to show selective target engagement of AβOs in AD patients
- Targets AβOs, which accumulate early in disease progression and are linked to synaptic dysfunction
- Potential "next generation" treatment for early AD, addressing a critical unmet need
The advancement to Phase 2 trials and exploration of a subcutaneous formulation are positive indicators. However, the complex nature of AD and previous failures in the field warrant cautious optimism. The collaboration with Lonza for both DS and DP manufacturing strengthens Acumen's position but doesn't guarantee clinical or commercial success.
- 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
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).
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.
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.
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.”
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.”
About 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.
About Acumen Pharmaceuticals, Inc.
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 www.acumenpharm.com.
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 “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.
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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FAQ
What is the purpose of Acumen Pharmaceuticals' extended collaboration with Lonza for sabirnetug (ABOS)?
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