AC Immune Expands Phase 1b/2a Alzheimer’s Vaccine Trial

 Previous interim results showing strong safety and potent immunogenicity support trial expansion and advancement of ACI-35.030 into Phase 2b/3

Alternative vaccine candidate also advances to second highest dose group based on encouraging interim results

AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that the Company and its strategic partner Janssen Pharmaceuticals, Inc., have expanded the ongoing Phase 1b/2a clinical trial of the Companies’ first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease (AD). The trial expansion, which is based on encouraging interim safety, tolerability and immunogenicity results to date, specifically includes vaccination of additional AD patients at the second highest dose to support continued development of ACI-35.030 into Phase 2b/3. In parallel, the trial continues to evaluate patients in the highest dose cohort, for which the first interim results will be available in Q4 2021.

Interim results from the low and second highest dose groups of the Phase 1b/2a trial showed that ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD with no clinically relevant safety concerns observed to date. These data, as well as additional interim Phase 1b/2a results, will be presented at an upcoming medical congress.

Long-term immunization with vaccines represents a valuable strategy for treatment and potentially prevention of AD and other neurodegenerative diseases. ACI-35.030 is the first AD vaccine candidate designed to generate antibodies that specifically target pathological pTau proteins in the brain. Anti-pTau antibodies generated continually in the body by ACI-35.030 have the potential to reduce and prevent the spread and seeding of Tau pathology, which is a major hallmark of AD.

https://finance.yahoo.com/news/ac-immune-announces-expansion-phase-110000905.html