AC Immune gets FDA fast track for Alzheimer's vaccine

AC Immune has recently achieved a significant milestone with its phosphorylated Tau (pTau)-targeting vaccine, JNJ-2056, which has been granted fast track designation by the US Food and Drug Administration (FDA) for treating Alzheimer’s disease. This promising candidate, initially known as ACI-35.030, is currently under investigation in the Phase IIb ReTain clinical trial. The trial is particularly notable because it targets individuals with preclinical Alzheimer’s disease, a stage where patients have not yet exhibited clinical symptoms. According to AC Immune, JNJ-2056 is the first active immunotherapy to be tested in such an early stage of the disease.

The design of JNJ-2056 aims to mitigate the spread of the tau protein, which tends to aggregate and form tangles in the brains of individuals suffering from Alzheimer’s. This investigational vaccine demonstrated promising efficacy in an earlier Phase Ib/IIa trial (NCT04445831), where it successfully triggered the immune systems of patients, resulting in a strong antibody response against both phosphorylated tau and its aggregated harmful form.

The development of JNJ-2056 is part of a collaborative global license, development, and commercialization agreement with Johnson & Johnson Innovation Medicine (J&J). This partnership, which began in 2022, focuses on advancing the vaccine’s development.

In addition to JNJ-2056, AC Immune has another notable vaccine candidate, ACI-24.060. This candidate was acquired by Japanese pharmaceutical company Takeda in May 2024. Takeda signed an exclusive, worldwide option and license agreement for the amyloid beta-targeting Alzheimer’s disease immunotherapy, with the deal valued at up to $2.2 billion.

The Alzheimer’s disease treatment landscape is currently dominated by monoclonal antibodies (mAbs), such as Eli Lilly’s Kisunla (donanemab), which recently received FDA approval after previous setbacks. The leading drug in this space is Biogen’s Leqembi (lecanemab), projected to generate $6.1 billion in revenue by 2030, according to GlobalData consensus forecasts. Nonetheless, experts have suggested that if Alzheimer’s vaccines prove to be effective, they could offer several advantages over mAbs, including being more affordable, safer, and more convenient.

Interest in Alzheimer’s disease research is set to increase with the upcoming Alzheimer’s Association International Conference (AAIC) 2024, scheduled to take place in Philadelphia from July 28 to August 1. AC Immune will participate actively, delivering three presentations at the conference, including one focusing on ACI-24.060.

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