AC Immune’s Anti-Abeta Vaccine Results from Phase 1b Study in Down Syndrome Published in JAMA Neurology
First study of an anti-Abeta vaccine in people living with Down syndrome (DS)
Immune response and Alzheimer's disease (AD) biomarkers showed positive impact of ACI-24 first generation vaccine
Optimized formulation of the ACI-24 vaccine to enter Phase 1b/2 testing this year
LAUSANNE,
The landmark study was led by principal investigator
Dr.
Dr. Marie Kosco-Vilbois, Ph.D., Chief Scientific Officer of AC Immune and one of the co-authors of the article, concluded: "The ACI-24 vaccine is derived from our SupraAntigen® platform and designed to generate a polyclonal antibody response targeting pathological forms of Abeta, which following the optimization of its formulation now also includes oligomeric and pyroGlutamate-Abeta. The ensemble of clinical results obtained with ACI-24, encourage us to push the program forward taking the optimized ACI-24 formulation into the next stage of clinical development in both AD and AD in DS in 2022."
As presented in the JAMA Neurology article, the ACI-24 vaccine demonstrated immunogenicity along with pharmacodynamic and target engagement evidence as measured by a greater increase in plasma Abeta40 and Abeta42 in treated groups compared to placebo. Importantly, anti-Abeta antibody titers were not associated with any adverse findings.
An optimized formulation of ACI-24 has demonstrated strong immunogenicity, inducing a polyclonal response in non-human primates against Abeta and, importantly, high titers of antibodies targeting pyroGlutamate-Abeta (as published in
References
- Rafii MS et al, Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome, A Phase 1b Randomized Clinical Trial, JAMA Neurology, 2022 May 9:79(5).
- Jawhar S et al, Pyroglutamate Amyloid-β (Aβ): A Hatchet Man in Alzheimer Disease, J Biol Chem. 2011 Nov 11; 286(45).
About the Phase 1b anti-Abeta Vaccine Trial in people living with DS
This randomized, double-blind, placebo-controlled, dose-escalation, phase 1b multi-center study reported in JAMA Neurology included 16 adults, aged 25-41 years. Participants were treated for 48 weeks receiving seven subcutaneous injections of ACI-24 (300μg or 1000μg) or placebo (active/placebo ratio was 3:1) and monitored for an additional 48 weeks of post-treatment follow-up. Primary outcomes included assessment of safety, tolerability and antibody titers. Exploratory outcomes evaluated included levels of plasma and CSF amyloid-β42, amyloid-β40, total tau and phospho-tau (pTau) as well as hippocampal volume and cognitive functioning. In the trial, most adverse events were of mild intensity and unrelated or unlikely related to ACI-24. Treatment compliance was 100%. No cases of meningoencephalitis, death or other serious adverse events occurred as well as no withdrawals due to adverse events.
About
SupraAntigen® is a registered trademark of
For further information, please contact:
Media Relations Phone: +41 21 345 91 34 Email: saoyuth.nidh@acimmune.com |
Investor Relations Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com |
LaVoieHealthScience Phone: +1 609 516 5761 Email: slewis@lavoiehealthscience.com |
U.S. Investors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com |
Forward looking statements
This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the
Source: AC Immune SA