AC Immune Reports Promising Results from Tau-Targeting Alzheimer’s Trial

Swiss-based biopharmaceutical company AC Immune SA has announced peer-reviewed findings from its Phase 1b/2a trial, marking a significant step forward in the pursuit of an effective therapy for early Alzheimer’s disease

The study evaluated two Tau-targeting active immunotherapies – ACI-35.030 and JACI-35.054 – both designed to combat the abnormal accumulation of phosphorylated Tau (pTau), a hallmark of Alzheimer’s pathology.

ACI-35.030 Shows Robust and Sustained Response

Developed using AC Immune’s proprietary SupraAntigen™ technology, ACI-35.030 demonstrated a rapid, potent, and sustained polyclonal antibody response against pathological forms of Tau, including both phosphorylated Tau (pTau) and brain-derived Tau (ePHF). 

Remarkably, all participants became anti-pTau IgG responders within two weeks of receiving a single dose.

The data revealed exceptionally strong and consistent immune responses, with response rates between 94% and 100% maintained through week 74 in the high-dose cohorts. 

Moreover, the therapy showed clear specificity, as antibody levels against normal Tau declined with continued dosing – suggesting that ACI-35.030 effectively targets disease-associated proteins while sparing normal brain function.

JACI-35.054 Delivers Variable Results

In comparison, JACI-35.054, which targets the same pTau peptide sequence, produced more variable immune responses and required multiple administrations to reach antibody levels comparable to ACI-35.030. 

Furthermore, JACI-35.054 induced antibodies against normal Tau after the second dose, which increased with further treatments – indicating a less selective immune response.

Despite these differences, both therapies were reported to have no clinically relevant safety or tolerability issues, underscoring the potential viability of active immunotherapy in Alzheimer’s treatment.

Advancing to Phase 2b: The ReTain Trial

Given its superior profile, ACI-35.030 (also known as JNJ-2056) has been selected to advance into the Phase 2b ReTain trial, now underway with approximately 500 participants who are in the preclinical stages of Alzheimer’s disease. 

This trial aims to further validate the therapy’s safety, immunogenicity, and potential to slow or prevent disease progression before symptoms fully manifest.

A Step Forward in Alzheimer’s Research

Commenting on the findings, AC Immune’s CEO emphasised that ACI-35.030 was well tolerated at all tested doses, inducing a rapid and sustained immune response against pathological Tau while requiring less frequent dosing compared to traditional monoclonal antibody therapies

They added that these results highlight the strength of AC Immune’s SupraAntigen platform, capable of producing highly differentiated active immunotherapies even when using identical immunogens.

Conclusion

The results from AC Immune’s Phase 1b/2a trial reinforce the company’s position at the forefront of Alzheimer’s innovation. By demonstrating a safe, sustained, and disease-specific immune response, ACI-35.030 offers fresh optimism in the fight against a condition that continues to affect millions worldwide. 

As the Phase 2b ReTain trial progresses, researchers and patients alike will be watching closely – hopeful that this novel approach could one day help rewrite the course of Alzheimer’s disease.

News Credits: AC Immune’s Tau-targeting therapy shows promise in early Alzheimer’s trial

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