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. 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.
At the 2013 CTAD conference, Araclon scientists announced that ABvac40 was entering human testing. At the 2016 AAIC, 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. 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 February 2018, a Phase 2 trial started at sites across Spain; as well as sites in France, Italy, and Sweden. This study is enrolling 120 people with amnestic MCI or very mild AD to compare a one-year course of ABvac40 or placebo on safety outcomes and immune responses monitored for two years. It stratifies participants by positivity on an amyloid PET scan, and compares biomarkers, cognitive, and quality-of-life measures between the negative and positive groups. According to data presented at AAIC in July 2020, recruitment is complete, with 135 participants randomized to treatment or placebo. Three-quarters were amyloid-positive on PET. As of June 2020, 124 participants had had at least one dose. Most experienced mild adverse events, but 7.3 percent had a serious treatment-related adverse event. There have been 14 incidents of ARIA-H and no deaths. The trial is expected to finish in February 2022.
For details of ABvac40 trials, see clinicaltrials.gov.
Last Updated: 16 Sep 2020
- 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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