AC Immune and partner Janssen have found an early-stage Alzheimer’s disease vaccine spurs induction of antibodies that attack a type of tau, which is believed to tangle up in the brain and contribute to the devastating neurological disorder.
The interim data for ACI-35.030 come from the high-dose group in a phase 1b/2a clinical trial of patients with early Alzheimer’s. AC Immune and the Johnson & Johnson unit are studying the safety and immunogenicity of the tau vaccine candidate. The pair previously reported data from the low- and mid-dose cohorts.
With these new data, AC Immune has the evidence needed to “support plans for further late-stage development,” according to a Tuesday press release. The study had already been expanded to include 24 patients in the mid-dose cohort to collect more information on immunogenicity and safety.
AC Immune said the results show the induced immune response selectively targets phosphorylated-tau, or pTau, a type of the protein that appears in patients with Alzheimer’s years before accumulation can be detected using brain imaging. The biotech believes addressing tau through a vaccine can lead to early treatment and even prevention of Alzheimer’s.
Assessed at Week 10 after a second dose, patients had levels of antibodies that were reactive to pathological tau. No safety signals were flagged in the study.
Secondary endpoints for the study will also examine additional immunogenicity parameters, and other exploratory endpoints will look at biomarkers that suggest Alzheimer’s progression and clinical assessments. The study kicked off in the third quarter of 2019.
AC Immune CEO Andrea Pfeifer, Ph.D., told Fierce Biotech in December that a key part of the biotech’s strategy for developing Alzheimer’s vaccines is diagnostics. The company is working on four different projects to aid Alzheimer’s diagnosis to ensure early treatment.
The biotech also has Alzheimer's partnerships with Roche's Genentech and Eli Lilly.