Vaccine Info

ACI-24 anti-Abeta Vaccine

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Last reviewed
June 27, 2023
Fact checked by
Robert Carlson, MD

ACI-24.060 anti-Abeta Vaccine Active Immunotherapy 2023

ACI-24.060 anti-amyloid-beta (Abeta) vaccine active Immunotherapy candidate is designed to generate antibodies targeting misfolded Abeta to prevent accumulation and enhance clearance of amyloid plaques. The ACI-24 anti-Abeta vaccine candidates are expected to produce a broad immune response binding key pathological species such as Abeta oligomers and the highly neurotoxic pyroglutamate Abeta (N3pE-Abeta). This investigational candidate has the potential to inhibit plaque formation and increase plaque clearance efficiently and thereby may reduce or prevent disease progression.

ACI-24.060 is derived from AC Immune's SupraAntigen® platform. It has been shown in preclinical studies to induce a strong polyclonal antibody response that matures and is maintained against both oligomeric and pyroglutamate-Abeta species. These essential pathological forms of Abeta are believed to drive Abeta plaque formation and disease progression. ACI-24.060 is designed to enhance the formation of broad-spectrum protective antibodies with the same safety and tolerability previously demonstrated in the ACI-24 program in Phase 1 and 2 trials.

Targeting Abeta using antibodies has recently been validated with U.S. Food and Drug Administration (FDA) approvals of new monoclonal antibody (mAbs) treatments for patients with AD. By eliciting polyclonal anti-Abeta antibodies, the ACI-24.060 anti-Abeta vaccine development program aims to ultimately deliver significant benefits to patients, their caregivers, and healthcare systems regarding potential safety and tolerability, low-frequency dosing, low overall costs, and durable responses.

Early results from the first cohort of AD patients in the phase 1/2 ABATE clinical study showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection). The data show that ACI-24.060 vaccination has been safe and well tolerated to date. As a result, dosing in ABATE's second, higher-dose AD cohort began, and the trial was cleared to start screening individuals with DS for part 2 of the study. Further safety and immunogenicity findings from ABATE cohorts are expected in H2 2023. And the initial data on amyloid plaque reduction measured via PET imaging is anticipated in 2024. On June 27, 2023, the company confirmed the FDA awarded Fast Track Designation. This follows FDA clearance of the Investigational New Drug (IND) application enabling expansion of the ongoing ABATE study in patients with AD and individuals with Down syndrome (DS).

AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins. 

ACI-24 anti-Abeta Vaccine Indication

ACI-24 anti-Abeta vaccine candidates are indicated to slow Alzheimer's disease and dementia progression.

ACI-24 anti-Abeta Vaccine News 2023

June 27, 2023 - Dr. Johannes Streffer, CMO of AC Immune SA, commented: "ABATE's expansion into the USA will allow us to accelerate the trial's advancement and build upon the strong momentum we've generated in Europe. With today's announcement, we remain firmly on track to report additional interim safety and immunogenicity data later this year and for the crucial interim readout of Abeta-PET imaging data in AD in the first half of next year. By benchmarking the amount of Abeta plaque reduction achieved with ACI-24.060 against those achieved with FDA-approved monoclonal antibodies, we believe we can generate early evidence of our vaccine's therapeutic potential to support its expeditious advancement towards pivotal programs in AD and DS-related AD."

January 26, 2023 - AC Immune SA announced the first interim safety, tolerability, and immunogenicity findings from the Phase 1b/2 ABATE trial of its Abeta vaccine ACI-24.060 in patients with prodromal AD. ABATE will now be expanded, as planned, to include individuals with Down syndrome and to evaluate higher doses in Alzheimer's patients. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are delighted with the encouraging initial safety and immunogenicity findings for ACI-24.060 in ABATE reported today. We believe ACI-24.060's successful development could provide patients with a novel therapeutic option offering numerous potential advantages in treatment, maintenance, and prevention settings. These early findings from ABATE represent an important step towards this goal, and we look forward to reporting more detailed data at a future conference."

February 4, 2022 - AC Immune announced their wholly-owned ACI-24, an amyloid-beta vaccine program. Preclinical data show the optimized ACI-24 formulation induced a broad polyclonal anti-Abeta response, including high titers of antibodies targeting pyroGlu-Abeta variants, and was well tolerated in non-human primates and mice.

ACI-24 anti-Abeta Vaccine Clinical Trials

The original formulation of ACI-24 has been evaluated in a Phase 1b/2 and a Phase 2 trial in AD patients, and a Phase 1b trial in individuals with DS. ACI-24.060 targets the same toxic species as disease-modifying anti-Abeta monoclonal antibodies that slowed AD progression in Phase 3 clinical trials. 


Clinical Trials

No clinical trials found