Interim data from Swiss clinical trial reveals safety, efficacy of AD vaccine

Swiss-based biopharmaceutical company AC Immune SA announced promising new interim data on the safety and efficacy of its ACI-35.030 vaccine for patients with early Alzheimer’s disease, according to a company press release.

Based on AC Immune’s SupraAntigen platform, ACI-35.030 is designed to generate antibodies targeting pathological phosphorylated-Tau (pTau) in the brain. New results from a high-dose ACI-35.030 cohort in a placebo-controlled phase 1b/2a trial show strong induction of antibodies selective for pTau and its aggregated form of enriched paired helical filaments. Previous findings from the trial’s mid-dose cohort showed median anti-pTau antibody titers increasing two-fold from baseline at week 2 after the initial injection.

Additional results from the interim analysis include:

an induced immune response that selectively targets pTau, as evidenced by an increase in the anti-pTau/anti-Tau IgG ratio up to week 10 of the trial; boosted median levels of antibodies reactive with pathological Tau with both the first and second vaccine injections; and absence of clinically relevant safety or tolerability concerns over vaccine administration.

Initiated by AC Immune SA in 2019, the ongoing study assesses the safety, tolerability and immunogenicity of different dosages of ACI-35.030 and JACI-35.054 in participants with early AD. The vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals Inc.

“With these results we believe ACI-35.030 holds significant promise as a first-in-class therapeutic that could shift the AD treatment paradigm towards earlier treatment and prevention, especially when used alongside cutting-edge pTau diagnostics as part of a precision medicine approach,” Andrea Pfeifer, CEO of AC Immune SA, said in the release. “We look forward to the continued development of ACI-35.030.”