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 are 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 conference in Toronto, they reported results of a Phase 1 study. According to this talk, this was a double-blind parallel group trial that 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. Also according to this AAIC presentation, the vaccine appeared safe in this trial, 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 (see Lacosta et al., 2016).
According to Araclon's website, Phase 2 has been underway since 2015, and plans are underway to start Phase 3 in 2017.
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