Name: Lu AF20513
Therapy Type: Immunotherapy (active) (timeline)
Target Type: Amyloid-Related (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 1)
Company: H. Lundbeck, Otsuka Pharmaceutical Co., Ltd.
This is an active vaccine designed to overcome the weak immune system of aged populations while avoiding auto-immune T cell responses. The Lu AF20513 epitope intersperses three repeats of the first 12 amino acids of the Aβ peptide with sequences of tetanus toxin. The goal of this kind of mixed-peptide engineering is to rouse an elderly population of non-self memory T cells originally generated by childhood tetanus vaccinations to stimulate T helper cells, which in turn activate a B cell response to produce polyclonal antibodies against Aβ. A preclinical study in mice, guinea pigs, and monkeys characterized the cellular and humoral immune response against this vaccine, reporting high Aβ titers, no autoreactive T cells, and removal of brain amyloid deposits (Davtyan et al., 2013).
In March 2015, an open-label Phase 1 trial started to enroll what is to be 35 people with probable Alzheimer's disease, a CSF Aβ antibody measurement, and a recent MRI consistent with an AD diagnosis. The trial will administer multiple shots of either a low, medium, or high dose to participants, and measure antibody titers as well as safety and tolerability over a period of two years. This trial takes place in Austria, Finland, and Sweden and is set to conclude in May 2017.
For more detail, see clinicaltrials.gov.
- Davtyan H, Ghochikyan A, Petrushina I, Hovakimyan A, Davtyan A, Poghosyan A, Marleau AM, Movsesyan N, Kiyatkin A, Rasool S, Larsen AK, Madsen PJ, Wegener KM, Ditlevsen DK, Cribbs DH, Pedersen LO, Agadjanyan MG. Immunogenicity, efficacy, safety, and mechanism of action of epitope vaccine (Lu AF20513) for Alzheimer's disease: prelude to a clinical trial. J Neurosci. 2013 Mar 13;33(11):4923-34. PubMed.
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