Name: ABvac 40
Therapy Type: Immunotherapy (active) (timeline)
Target Type: Amyloid-Related (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2)
Company: Araclon Biotech
ABvac40 is an investigational vaccine targeting the C terminus of Aβ40. This construct comprises multiple repeats of a short C-terminal fragment of Aβ40. To generate an immune response, the repeats are conjugated to the keyhole limpet cyanine (KHL) carrier protein and formulated with the adjuvant alum hydroxide (see company press release). Preclinical studies have been presented at CTAD and other scientific conferences, though none are published in peer-reviewed journals. Araclon Biotech is a company based in Zaragoza, Spain, and owned by Grifols.
As of November 2016, clinical trials for ABvac40 were not registered in clinicaltrials.gov, the WHO International Clinical Trials Registry, or Spain's clinical studies registry REec.
At the 2013 CTAD conference in San Diego, Araclon scientists announced that ABvac40 was entering human testing. At the 2016 AAIC in Toronto, they reported results of a Phase 1 study. According to this talk, this double-blind parallel group trial had enrolled 24 people with mild to moderate AD and randomized them vaccine to placebo 2:1. Outcomes included safety, tolerability, and immunogenicity of ABvac40. The first four participants received two half-doses of ABvac40, the second group of four received two full doses, the remaining 16 received three full doses at monthly intervals. According to this presentation, the vaccine appeared safe, with self-limiting injection site swelling, headache, and erythema possibly related to the immunotherapy, but no incidents of vasogenic edema or microhemorrhage. Eleven of 12 participants who received three injections of ABvac40 generated antibody titers (podium presentation by Lacosta et al., 2016). This trial was retroactively added to clinicaltrials.gov and results were published (Lacosta et al., 2018).
In October 2017, a Phase 2 trial started at sites across Spain; additional sites in Europe are planned. This study is enrolling 120 people with amnestic MCI or very mild AD to compare a two-year course of ABvac40 or placebo on safety outcomes and on parameters of the immune response to ABvac40. This study stratifies its participants by positivity on an amyloid PET scan, and compares biomarkers, cognitive, and quality-of-life measures between the negative and positive groups. For details, see trial entry on REec.
Last Updated: 02 Feb 2018
- Lacosta AM, Pascual-Lucas M, Pesini P, Casabona D, Pérez-Grijalba V, Marcos-Campos I, Sarasa L, Canudas J, Badi H, Monleón I, San-José I, Munuera J, Rodríguez-Gómez O, Abdelnour C, Lafuente A, Buendía M, Boada M, Tárraga L, Ruiz A, Sarasa M. Safety, tolerability and immunogenicity of an active anti-Aβ40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Alzheimers Res Ther. 2018 Jan 29;10(1):12. PubMed.
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