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ADDL-Select™ antibodies with selective affinity against soluble Aβ oligomers are the core technology of Acumen. ACU-193, the lead antibody within the Acumen ADDL-Select™ program, is a fully humanized, IgG2 monoclonal antibody that selectively binds soluble Aβ oligomers and potently blocks their deleterious actions. Several backup ADDL-Select™ antibodies have been generated and characterized and remain in early pre-clinical development.
ACU-193 emerged from an eight-year partnership with Merck & Co., Inc. directed at anti-ADDL immunotherapy discovery and development. In 2011, due to contractual diligence obligations and Merck’s restructuring after its merger with Schering-Plough, Acumen reacquired exclusive rights to ACU-193 and the anti-ADDL program, with no residual financial or other obligations to Merck.
Acumen’s lead drug candidate for Alzheimer’s, ACU-193, selectively binds soluble Aβ oligomers with nanomolar affinity, with insignificant binding to Aβ monomers, β-amyloid or vascular amyloid in the brain. ACU-193 shows no cross-reactive binding to other proteins. In vivo, soluble Aβ oligomer engagement and behavioral and biochemical efficacy of ACU-193 has been demonstrated in multiple transgenic mouse models of Alzheimer’s disease. ACU-193 exhibits linear, dose-dependent pharmacokinetics, biodistribution, and brain penetration in four animal species with values that are typical for therapeutic antibodies. Exploratory safety and toxicity studies in monkeys reveal an overall excellent safety profile. A stable, high yielding cell line suitable for cGMP-production of ACU-193 is available. ACU-193 is approximately one year from IND filing and the start of clinical studies.
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Soluble Aβ oligomers have been detected and measured in postmortem extracts of human brain tissues. Several independent studies suggest that soluble Aβ oligomer levels in the cerebrospinal fluid of Alzheimer patients are higher than levels in people not suffering from Alzheimer’s. Thus, their detection in living patients is expected to provide a useful diagnostic tool, both, as a companion diagnostic for the development of ACU-193 and possibly as a free-standing diagnostic to identify very early stage Alzheimer’s patients. An ultra-high sensitivity assay with a detection limit of 0.1 pg/mL and 5000-fold selectivity for soluble Aβ oligomers versus Aβ monomers has been developed based on ADDL-Select™ antibodies.
Acumen plans to use the ultra-high sensitivity assay to measure soluble Aβ oligomer levels in the cerebrospinal fluid in patients to be enrolled in clinical trials with ACU-193. In addition, Acumen is exploring the utility of this assay as free-standing diagnostic tool.
Acumen IP Estate
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Synthetic soluble Aβ oligomer (“ADDL”) composition of matter and methods of use patents:
- Issued in CA, EP, CH, DE, ES, FR, GB, IT, JP, US, MX.
- Expire 2017-2020
Anti-ADDL antibodies; composition of matter and methods of use patents:
- Issued patents: US, AU, CA, EP, JP;
- Patents pending: US, AU, CA, EP, JP, BR, CN, KR, RU;
- Expire 2025-2031
Methods patents for detecting soluble Aβ oligomers:
- Diagnostic methods based on soluble Aβ oligomers;
- Issued patents: US, DE, FR, GB, JP;
- Patents pending: US, AU, CA, EP, JP;
- Expire 2026-2031
ADDL assembly blocker, ADDL receptor, and Misc. IP:
- IGg2m4 IP: issued US, expires 2027
- ADDL assembly blocker patents issued: EP, MX, RU; pending US, CA; expire 2027
- ADDL binding polypeptide: pending US, CA; expire 2027