AC Immune SA is a clinical-stage biopharmaceutical company, which engages in the discovery and development of therapeutic and diagnostic products for neurodegenerative diseases. It leverages proprietary technology platforms to discover, design, and develop novel, proprietary medicines for prevention, diagnosis, and treatment of neurodegenerative diseases associated with protein misfolding. The company was founded by Jean-Marie Lehn, Claude Nicolau, Roscoe Brady, Fred van Leuven, Ruth Greferath, Andrea Pfeifer, and Alexey V. Eleesiv on February 13, 2003 and is headquartered in Lausanne, Switzerland.
Clinical Trials
19
9 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2003
Active, not recruiting
9
47.4%
Completed
4
21.1%
Recruiting
5
26.3%
Withdrawn
1
5.3%
No approval data available
- AC Immune reported that ACI-7104 met its primary safety and immunogenicity endpoints in a Phase 2 trial in patients with early Parkinson's disease. - All treated patients in the study developed robust antibody responses, and no significant safety concerns were observed with the vaccine candidate. - Exploratory analyses suggested a link between antibody levels and clinical outcomes, supporting expansion into a larger Phase 2 study.
- AC Immune's oral NLRP3 inflammasome inhibitor ACI-19764 was safe and well tolerated across single and multiple ascending dose cohorts in a first-in-human Phase I study. - Cerebrospinal fluid penetration was confirmed, supporting the molecule's intended use across neurodegenerative diseases including Alzheimer's and Parkinson's disease. - Serum half-life exceeded 30 hours, with daily doses of 10 mg or below achieving plasma concentrations above the IC90, and blinded data indicated dose-dependent inhibition of IL-1β release. - The trial has expanded into a Phase Ib cohort in patients with cardiovascular disease risk, with initial hsCRP data expected before the end of 2026.
- AC Immune SA and Eli Lilly amended their 2018 collaboration agreement to advance Tau aggregation inhibitor small molecules for Alzheimer's disease and other neurodegenerative diseases. - The amendment includes a CHF 10 million upfront payment and potential milestones exceeding CHF 1.7 billion, with IND-enabling studies planned for the first half of 2026. - Morphomer Tau candidates demonstrate oral bioavailability and specific binding to pathological Tau protein conformations, with preclinical data supporting their potential to inhibit aggregation across disease stages. - The collaboration reflects growing scientific evidence that targeting intracellular Tau could slow or halt neurodegenerative pathology, positioning these small molecules for early-stage treatment and prevention.
- AC Immune presented groundbreaking Phase 1 data showing the first in vivo images of TDP-43 pathology in human brains using their novel PET tracer ACI-19626 at the AD/PD 2026 conference. - The tracer demonstrated significantly higher uptake in key brain regions of patients with genetically defined frontotemporal dementia compared to healthy subjects, with good safety and tolerability profiles. - ACI-19626 has potential to enable precision medicine approaches across multiple neurodegenerative diseases including FTD, ALS, and LATE by providing reliable biomarkers for differential diagnosis. - The technology could revolutionize early diagnosis of neurodegenerative diseases that currently share similar clinical symptoms, making accurate diagnosis difficult and lengthy.
- AC Immune's ACI-7104.056 active immunotherapy demonstrated potential to slow Parkinson's disease progression in interim Phase 2 VacSYn trial results, marking the first time an alpha-synuclein-targeted active immunotherapy has shown such signals. - The treatment achieved 100% immunogenicity response rate and stabilized key disease biomarkers including alpha-synuclein levels in cerebrospinal fluid and neurofilament light, suggesting reduced neuronal damage. - Clinical assessments using the MDS-UPDRS scale showed trends toward symptom stabilization in treated patients compared to placebo, with no clinically relevant safety issues reported. - The company plans to seek regulatory feedback for accelerated development toward registration based on these promising results, with final Phase 2 data expected in mid-2026.
- Johnson & Johnson terminated its mid-stage AuTonomy study of posdinemab after the anti-tau antibody failed to show statistically significant reduction in cognitive decline compared to placebo in over 500 early-stage Alzheimer's patients. - The failure adds to a string of setbacks for tau-targeting treatments, following previous disappointments from Eli Lilly's LY3372689 and zagotenemab, and Roche's semorinemab programs. - Posdinemab's failure could cast doubt on the therapeutic potential of targeting tau tangles, one of the hallmark features of Alzheimer's disease alongside amyloid plaques. - The setback may impact enthusiasm for similar tau-targeting approaches being developed by Biogen, UCB, Voyager Therapeutics, and other companies in the field.
- Bristol-Myers Squibb has exercised its option on Prothena's PRX005, a tau-targeting antibody for Alzheimer's disease, in a deal potentially worth $2.2 billion with $55 million upfront. - PRX005 specifically targets the microtubule-binding region of tau protein, which correlates more closely with dementia stages than other tau regions according to cerebrospinal fluid analysis. - The antibody completed phase 1 single ascending dose studies showing safety and effective central nervous system penetration, with multiple ascending dose results expected by year-end. - This move makes PRX005 the centerpiece of BMS's neuroscience pipeline, marking the company's return to Alzheimer's drug development after previous exits from the field.
- AC Immune SA announced publication in Nature Communications of preclinical data on ACI-19626, a first-in-class brain PET tracer for imaging TDP-43 pathology in neurodegenerative diseases. - The Morphomer-based tracer demonstrates high specificity for pathological TDP-43 aggregates with rapid brain uptake and complete washout, potentially enabling precision diagnosis of ALS, FTD, and LATE. - ACI-19626 has advanced to Phase 1 clinical trials with initial readout expected in Q4 2025, addressing the diagnostic challenge of differentiating TDP-43 proteinopathies. - The development could revolutionize diagnosis and treatment of multiple neurodegenerative diseases that share clinical features, potentially enabling earlier intervention before irreversible damage occurs.
- AC Immune's ACI-35.030 demonstrated exceptional immunogenicity with 94-100% response rates in high-dose cohorts through week 74 in early Alzheimer's disease patients. - The SupraAntigen®-based therapy required only one injection to induce anti-pTau antibody responses in all participants, showing superior performance over the comparator JACI-35.054. - ACI-35.030 specifically targeted pathological tau species while sparing normal tau, with significant plasma biomarker changes (p<0.05) compared to placebo. - Based on these results, ACI-35.030 has advanced to a potentially registration-enabling Phase 2b trial in 500 preclinical Alzheimer's disease participants.
- AC Immune's ACI-7104.056 anti-alpha-synuclein active immunotherapy demonstrated a 20-fold increase in anti-alpha-synuclein antibodies after four immunizations in the Phase 2 VacSYn trial for early Parkinson's disease. - The company maintains a robust cash position of CHF 127.1 million providing funding into Q1 2027, supporting advancement of three active immunotherapies in Phase 2 development. - Multiple clinical milestones are expected in H2 2025, including additional VacSYn trial data and the filing of an IND for the novel NLRP3 inhibitor ACI-19764. - The Alzheimer's disease program ACI-24.060 will reach 12 months of treatment in the AD3 cohort by December 2025, with interim results expected in early 2026.
