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Acumen Pharmaceuticals Immunotherapy & ACU-193
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Diagnostics
Immunotherapy and ACU-193

Antibodies with selective affinity against soluble Aß oligomers / ADDLs represent the core technology of Acumen. ACU-193, the lead antibody within the Acumen anti-ADDL antibody program, is a fully humanized, IgG2 monoclonal antibody, capable of selective binding ADDLs and potent blocking of their deleterious actions. Several backup product candidates have been generated in the program.

ACU-193 has been derived from the murine monoclonal anti-ADDL antibody 3B3, originally identified by Acumen scientists. ACU-193 emerged from an eight year partnership with Merck & Co., Inc. directed at anti-ADDL immunotherapy. The partnership was dissolved by mutual agreement in 2011, when all rights and materials related to ACU-193 and the anti-ADDL program reverted to Acumen.

ACU-193 binds ADDLs with high affinity and selectivity. Nanomolar affinity for ADDL binding has been measured by various methods, with insignificant binding to Aß monomers, ß-amyloid in the brain, and vascular amyloid. ACU-193 shows no cross-reactive binding to other proteins. Efficacy of ACU-193 in vitro has been demonstrated in neuronal cell cultures. Aß soluble oligomer engagement and efficacy of ACU-193 in vivo has been demonstrated in a transgenic mouse model of Alzheimer’s disease. ACU-193 exhibits linear, dose-dependent pharmacokinetics, biodistribution, and brain penetration in the range of values that are typical for therapeutically used antibodies. Exploratory safety and toxicity studies in monkeys revealed an overall excellent safety profile of ACU-193.

ACU-193 is approximately one year from IND filing and the start of clinical studies. Clinical development plans for ACU-193 reflect the availability of biomarker assays and the expectation that behavioral efficacy is achieved relatively quickly. It is anticipated that initial evidence for efficacy will be obtained in a Phase Ib study of relatively short duration and cost.

Basic Structure of an Antibody

 

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