AC Immune AG

AC Immune AG(ACIU)资讯与事件

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ACIU 资讯

ACIU 事件

9/23 07:30

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.

8/11 08:00

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.

6/30 07:30

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.

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