Thursday, August 1, 2019 @ 12:00 am
Clinically advanced vaccine, ACI-35.030, designed to reduce and to prevent the spread and development of Tau pathology
AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced the initiation of a Phase 1b/2a clinical trial to evaluate ACI-35.030, an anti-phospho-Tau (anti-pTau) vaccine. ACI-35.030 targets pathological Tau and is intended as a disease-modifying treatment for Alzheimer’s disease (AD) and other Tauopathies.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “Pathological Tau deposits are one of the key hallmarks of AD. Their characteristic distribution within the brain coincides with clinical symptoms and disease progression. Targeting phospho-Tau is therefore a very promising approach for treating and preventing this debilitating disease and as such, it is a key part of AC Immune’s Roadmap to Successful Therapies for Neurodegenerative Diseases.”
By targeting specific pathological forms of Tau protein, immunization with anti-Tau vaccines has become an important strategy for the treatment of AD and other Tauopathies because it has the potential to prevent and reduce the development and spread of Tau pathology throughout the brain. AC Immune’s two proprietary technology platforms, SupraAntigenTM and MorphomerTM, have generated anti-Tau therapies and diagnostics including four in clinical development.This Phase 1b/2a trial is a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 in patients with early AD. Secondary objectives will assess additional immunogenicity parameters, while exploratory endpoints will include notable biomarkers of progression of AD as well as clinical assessments.
AC Immune is developing ACI-35 and ACI-35.030 in collaboration with Janssen Pharmaceuticals, Inc. under a 2014 licensing agreement to develop and commercialize therapeutic anti-Tau vaccines for the treatment of AD and potentially other Tauopathies.
ACI-35.030ACI-35.030 is a potent liposomal anti-pTau active investigational vaccine designed to elicit antibodies against extracellular phosphorylated pathological Tau protein, in order to prevent and reduce the spread and development of Tau pathology within the brain.It builds on the success of AC Immune’s ACI-35 vaccine, which has demonstrated an early target-specific antibody response against pTau after the first injection in the vast majority of patients in a Phase 1b study in mild-to-moderate AD.
In pre-clinical studies, ACI-35.030 has shown that it retains the excellent non-clinical safety profile and the highly specific antibody response against pathological Tau observed in ACI-35, while demonstrating an enhanced and more homogeneous antibody response with a significant, long-lasting boosting effect.