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ACIU-News
ACIU-Events
AC Immune Reports Positive Results for ACI-7104 Phase 2 Trial
AC Immune announced positive safety and immunogenicity results through week-100 in Part 1 of VacSYn, its randomized, double-blind, placebo-controlled Phase 2 trial of ACI-7104 in patients with early-stage Parkinson's disease. The study is being conducted in two parts with the aim for Part 1 being to show safety, tolerability and immunogenicity while Part 2 is designed to provide evidence of clinical activity as the basis for a Phase 3 decision. The Part 1 data reported today includes results from all 34 patients randomized into the study. The primary endpoints for Part 1 of the VacSYn trial of ACI-7104 were safety, tolerability and immunogenicity, all of which were met. ACI-7104 was generally safe and well-tolerated and shown to be strongly immunogenic, with 100% of patients developing antibodies against the immunizing a-syn target antigen PD01 after three immunizations.
AC Immune Receives FDA Fast Track Designation for Parkinson's Drug
AC Immune announced that it has received fast track designation and clearance of its investigational new drug, or IND, application from the FDA for its wholly owned anti-alpha-synuclein active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson's disease. ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognizing aggregated a-syn species that are toxic to neurons. The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson's disease, with final Part 1 week-100 results on track to be announced in H2.
AC Immune Releases Interim Data from Alzheimer's Trial
AC Immune announced interim data from the first three cohorts of 74 patients with prodromal Alzheimer's disease in the Phase 1b/2 ABATE trial following 12 months of treatment with ACI-24 anti-amyloid beta active immunotherapy. ACI-24 anti-Abeta active immunotherapy generally safe and well tolerated in first three Alzheimer's disease cohorts in ABATE Anti-Abeta antibody dose-response demonstrated with antibodies detected at all dose levels in cohorts AD1-3 Ongoing AD4 cohort includes additional adjuvant designed to enhance ACI-24 responses. In the trial to date, ACI-24 has been generally safe and well tolerated, with no evidence of amyloid-related imaging abnormalities-edema. Anti-Abeta antibody responses were detected at every dose level with a dose response. The company evaluated enhancing ACI-24 with an additional adjuvant to boost immunogenicity while the ABATE trial was ongoing. This is currently being tested in the recently initiated ABATE Cohort AD4.
AC Immune Presents New ALS Study Data
AC Immune SA announced the presentation of new preliminary data from a Phase 1 trial of its first-in-class TDP-43 positron emission tomography tracer ACI-19626 showing increased uptake in the brains of patients with amyotrophic lateral sclerosis. The results presented at the 2026 TDP43 Summit in Madison, Wisconsin, demonstrate that PET scans with ACI-19626 showed tracer uptake significantly higher in key regions of the brain in patients with ALS compared to healthy controls. Specifically, tracer uptake was higher in the brain stem and precentral gyrus, where TDP-43 pathology is expected to accumulate based on post-mortem neuropathology studies and on clinical symptoms. Previously reported data showed significantly higher tracer uptake in disease-relevant subcortical and cortical regions in patients with genetic frontotemporal dementia.
AC Immune Reports Q1 Revenue of $1.12M, Exceeding Expectations
Reports Q1 revenue $1.12M, consensus $263,230. Andrea Pfeifer, CEO of AC Immune SA, commented: "The progress in our collaborations with Takeda and Eli Lilly reflect great confidence in our anti-Abeta active immunotherapy and Tau aggregation inhibitor small molecules, respectively. These have the potential to change the way we target the proteinopathies that drive Alzheimer's and other neurodegenerative diseases. This is further exemplified by the presentation of the interim results for ACI-7104 at AD/PD 2026 showing that our active immunotherapy targeting a-synuclein (a-syn) has the potential to modify disease pathology in Parkinson's disease. We also advanced our NLRP3 inhibitor ACI-19764 into clinical development, further demonstrating the power of AC Immune's technology to target the key pathways that contribute to neurodegeneration. We are now moving towards multiple value inflection points during 2026. These include Phase 2 data readouts on our active immunotherapies ACI-7104 and ACI-24, and initial results from the Phase 1 trial of ACI-19764 also anticipated this year."
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