ACIU News & Events

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.

Following a strategic review by executive management, the Company sharpened its focused investment on its most important assets. These include its three clinical-stage active immunotherapy programs, two of which are in ongoing pharma collaborations, and its most promising small molecule programs targeting NLRP3, Tau and a-synuclein. As a result, the Company has reduced its workforce by around 30% and extended its cash for operations to the end of Q3 2027.

The Company had total cash resources of CHF 108.5 million, composed of CHF 27.7 million in cash and cash equivalents and CHF 80.7 million in short-term financial assets. The Company's cash balance is expected to provide sufficient capital resources to the end of Q3 2027, excluding potential milestone payments.