Pharma Focus Europe

AC Immune's Immunotherapy Targeting Anti-pTau Advances to Phase 2b Trial for Alzheimer's Disease

Saturday, December 16, 2023

AC Immune SA (NASDAQ: ACIU) has revealed the commencement of a Phase 2b clinical trial to assess ACI-35.030 (JNJ-64042056) in patients with preclinical Alzheimer’s disease (AD), those who are not yet displaying symptoms. ACI-35.030 is an investigational targeted active immunotherapy designed to selectively target pathological phosphorylated Tau (pTau). Due to the known correlation between pTau and AD progression, the trial aims to demonstrate that ACI-35.030 has the potential to prevent or slow down the advancement of tau pathology and the onset of clinical symptoms.

As part of the collaboration with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, AC Immune is set to receive a CHF 15 million milestone payment and an additional CHF 25 million upon achieving a non-disclosed enrollment target. The partnership's goal is to develop and commercialize therapeutic anti-Tau active immunotherapies for the treatment of AD and potentially other Tauopathies.

Dr. Andrea Pfeifer, CEO of AC Immune SA, emphasized the promising results from the Phase 1b/2a trial, demonstrating the activation of patients' immune systems and a robust antibody response against phosphorylated Tau. The decision to advance to a Phase 2b trial targeting individuals not yet symptomatic underscores the potential to slow or prevent the progression to symptomatic AD.

The Phase 2b ReTain trial is designed as a potentially registration-enabling study, featuring a randomized, multicenter, double-blind, placebo-controlled approach with approximately 500 participants having preclinical AD. The trial will assess the clinical impact of active immunization with ACI-35.030 over a maximum period of 4 years. The primary endpoint is cognitive decline measured by the Preclinical AD Cognitive Composite 5 (PACC-5) score, sensitive enough to detect early changes in cognitive function. A key secondary endpoint involves assessing the effect of ACI-35.030 on the propagation and accumulation of Tau pathology using Tau PET imaging.

ACI-35.030, developed using AC Immune's SupraAntigen® platform, has demonstrated the ability to elicit a sustained and focused antibody response against pathological pTau in elderly patients with Alzheimer’s disease. The SupraAntigen® platform has proven successful in generating product candidates for active immunotherapy and monoclonal antibodies for passive immunization against neurodegenerative disease targets. In addition to Amyloid-beta and Tau, the platform has led to the development of antibodies against emerging targets such as alpha-synuclein, TDP-43, and the NLRP3 inflammasome pathway.



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