ACIU News & Events

AC Immune announced the presentation of Phase 1 data including the first in vivo images of TDP-43 pathology in the human brain, detected using its positron emission tomography - PET - tracer ACI-19626, at the International Conference on Alzheimer's and Parkinson's Disease. Initial data from the Phase 1 trial support ACI-19626's potential to detect pathological TDP-43 in the brains of patients with TDP-43 proteinopathies, enabling a precision medicine approach to multiple neurodegenerative diseases. Specifically, PET scans with ACI-19626 showed that tracer uptake was significantly higher in key regions of the brain in patients with frontotemporal dementia due to mutated C9orf72 than in the brains of healthy subjects. ACI-19626 showed good safety and tolerability, a dosimetry profile within accepted limits, and rapid brain uptake and washout, indicating a PK profile suitable for human brain imaging and potentially pharmacodynamic analysis of therapeutics targeting TDP-43 pathology. This potentially enables precision medicine across multiple neurodegenerative diseases.

Reports FY25 revenue CHF 3.753M vs CHF 27.309M last year. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We made significant progress towards delivering precision prevention of neurodegenerative diseases in 2025, exemplified by the exceptional interim data from the VacSYn trial of ACI-7104, our wholly-owned active immunotherapy targeting alpha-synuclein. Evidence that ACI-7104 appears to slow the rate of progression in early Parkinson's disease (PD) further demonstrates the potential for active immunotherapies as disease-modifying treatments with the potential to slow or prevent neuronal damage."

AC Immune announced that the first participant has been dosed in a Phase 1 clinical trial of ACI-19764, an orally administered small molecule inhibitor of the NLRP3 inflammasome. Targeting the NLRP3 inflammasome provides an opportunity to reduce the chronic inflammation thought to be associated with disease progression in multiple inflammatory disorders, metabolic diseases, and neurological diseases, including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and frontotemporal dementia.

AC Immune announced positive interim safety and efficacy results from the Phase 2 VacSYn trial of its wholly-owned anti-alpha-synuclein active immunotherapy ACI-7104.056 in early Parkinson's disease, or PD. Results show, for the first time, that targeting a-syn pathology with an active immunotherapy could potentially slow the rate of progression of PD. Disease-related biomarker results suggest stabilization of PD pathology. In addition, total scores are suggestive of a trend for stabilization. Interim results showed all target criteria for immunogenicity were met, including: ACI-7104.056 induced a robust antibody response against the immunizing a-syn target antigen with a 100% responder rate; titers against the immunizing a-syn target antigen increased with successive immunizations, showing ACI-7104.056 generates antibodies that cross the blood-brain barrier. The stabilization of disease-relevant biomarkers in the central nervous system, suggests slowing of Parkinson's disease pathology, with potential disease modification. Levels of Neurofilament Light chain in the CSF remained stable in the ACI-7104.056 group and increased in the placebo group. Stabilization suggests a potential slowing of neuronal damage. Interim results from weeks 50 and 76 continue to demonstrate that ACI-7105.056 is generally safe and well-tolerated enabling a positive benefit/risk ratio. AC Immune aims to seek regulatory feedback on an ACI-7104.056 clinical development plan to potentially accelerate towards registration. Final data from Part 1 of the VacSYn trial are expected in mid-2026.