Developing strategies for preserving
quality of life

AC Immune is advancing one of the broadest product portfolios focused on pioneering precision medicine for neurodegenerative diseases. Leveraging our proprietary technology platforms, Morphomer® and SupraAntigen®, we are pursuing multiple therapeutic modalities in parallel by advancing diagnostics, antibodies, small molecules and active immunotherapies targeting carefully selected therapeutic targets: amyloid beta (Abeta), Tau, alpha-synuclein (a-syn), TDP-43 and (NOD)-like receptor protein 3 (NLRP3).

We believe adaptive biomarker-based trial designs provide the necessary flexibility in an increasingly dynamic regulatory environment and shorten the time from bench to bedside for our diagnostics and therapeutic candidates.

If you are interested in participating in one of our clinical trials or would like more information, we recommend you first discuss it with your medical doctor to provide guidance related to your specific situation.

anti-a-synuclein active immunotherapy in Parkinson's disease

Description

Our wholly owned candidate ACI-7104 is an optimized formulation designed to induce a-syn-specific antibodies recognizing aggregated a-syn species that are toxic to neurons.

Building on the strong Phase 1 data of the predecessor active immunotherapy (Volc D. et al., Lancet Neurol., 2020), ACI-7104 has advanced into an adaptive, biomarker-based Phase 2 study in early Parkinson’s disease.

This Phase 2 study has two parts: in the first part, we utilize biomarker-based interim analyses to tailor the dosing regimen and monitor the disease-specific biomarkers.

In part two, the goal is to generate clinical proof-of-concept in early Parkinson’s disease and to monitor the progression of motor and non-motor symptoms, as well as digital, imaging, and fluid biomarkers.

ClinicalTrials.gov (NCT06015841)

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Summary

AC Immune Technology Platforms Anti-ptau vaccine | Pioneering Precision Medicine for neurodegenerative diseases
Modality anti-a-synuclein active immunotherapy
Indication Early idiopathic Parkinson’s disease
Clinical stage Phase 2
Current status ongoing

anti-Abeta active immunotherapy in Alzheimer's disease and Alzheimer's disease in Down Syndrome

Description

art_Abate_Logo_RGB

AC Immune is pursuing clinical development with ACI-24.060, an optimized formulation of ACI-24, which is intended to prime, boost and maintain a strong antibody response against key pathological Abeta species (including oligomeric and pyroglutamate Abeta; Vukicevic M. et al., Brain Communications, 2022).

This Phase 1b/2 study, ABATE, will evaluate the active immunotherapy candidate in early Alzheimer’s disease and the target population will consist of both patients with Alzheimer’s disease and people living with Down syndrome, with evidence of presence of brain amyloid pathology.

ABATE is a multicenter adaptive, double-blind, placebo-controlled study that will assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060.

Key outcome measures for the study will include assessments of safety, immunogenicity, pharmacodynamics, Abeta-PET imaging, and target engagement.

ClinicalTrials.gov (NCT05462106)

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Learn more about the ABATE trial evaluating ACI-24.060 as a potential treatment for Alzheimer’s disease in Down syndrome here:

http://www.abate-study.com/

Summary

AC Immune Technology Platforms Anti-ptau vaccine | Pioneering Precision Medicine for neurodegenerative diseases
Modality anti-Abeta active immunotherapy
Indication Prodromal Alzheimer’s disease and Alzheimer's disease in Down Syndrome (AD in DS)
Clinical stage Phase 1b/2
Current status ongoing

anti-pTau active immunotherapy in Alzheimer's disease

Description

In collaboration with J&J Innovative Medicine, AC Immune is advancing the anti-phospho-Tau active immunotherapy candidate in subjects with early Alzheimer’s disease. It targets phosphorylated Tau proteins, a key component of the Alzheimer’s pathology that is found in Tau tangles, its aggregated form.

The Phase 1b/2a study (ClinicalTrials.gov NCT04445831) was a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 in patients with early Alzheimer’s disease.

ACI-35.030 was found to be safe and well tolerated and triggered a strong and sustained immune response (Sol O. et al, eBioMedicine 2025). JNJ-64042056 is currently being assessed in the Phase 2b Reτain trial (NCT06544616) sponsored by J&J Innovative Medicine.

Summary

AC Immune Technology Platforms Anti-ptau vaccine | Pioneering Precision Medicine for neurodegenerative diseases
Modality anti-phospho-Tau active immunotherapy
Indication early Alzheimer's disease, i.e. mild cognitive impairment (MCI) due to Alzheimer's disease and mild Alzheimer's disease
Clinical stage Phase 1b/2a
Current status completed

Tau-PET tracer in Alzheimer's and NeuroOrphan diseases

Description

With our partner, Life Molecular Imaging (LMI), we are advancing PI-2620 as a best-in-class Tau diagnostic for Alzheimer’s disease as well as other disorders caused by misfolding Tau protein, so-called tauopathies. These include progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD).

PI-2620 demonstrated excellent characteristics potentially allowing for differentiation between 3/4R- and 4R-tauopathies and might serve as a supportive readout in the diagnostic workup of neurodegenerative disorders.

The ADvance Phase 3 trial is an open-label, multi-center, non-randomized pivotal study to assess the efficacy and safety of PET imaging with [18F]PI-2620 for detection of Tau deposition in subjects with Alzheimer’s disease (AD) during lifetime when compared to histopathology obtained after death and completion of brain autopsy.  Two test-retest studies in PSP (Phase 1) are currently ongoing.

ClinicalTrials.gov (NCT05641688)

Summary

AC Immune Technology Platforms Pi-2620 | Pioneering Precision Medicine for neurodegenerative diseases
Modality Tau-PET imaging agent
Indication Alzheimer's and NeuroOrphan diseases
Clinical stage Phase 3 & Phase 1
Current status ongoing