AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA
James Spargo | July 26, 2024 | News story | Research and Development | AC Immune, Alzheimer’s disease, Neurology, clinical trials, fast track designation, immunotherapy, tau protein
Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) candidate ACI-35.030 (now called JNJ-2056) Fast Track designation.
ACI-35.030 is an active-immunotherapy targeting phosphorylated Tau (pTau). It has been shown to induce a strong polyclonal antibody response against Tau aggregation, thereby potentially reducing the pathological spread of Tau in the early stages of AD. ACI-35.030, now JNJ-2056, will be tested in the phase 2b ReTain trial, which is currently recruiting participants with preclinical AD.
Dr Andrea Pfeifer, CEO of AC Immune SA, commented: ‘Fast Track designation is an important recognition of the differentiation and potential value for patients of our anti-pTau active immunotherapy, ACI-35.030. The phase 2b ReTain study is the first time any active immunotherapy is being tested in a preclinical AD population. We believe this modality has the potential to offer therapeutic advantages, as well as benefits in terms of convenience and access. Fast Track designation offers opportunities for more efficient development and regulatory review. More importantly, this underscores and validates the potential therapeutic impact of an active immunotherapy specifically targeting pTau, the key pathologic species of Tau protein. In phase 1b/2a clinical testing, ACI-35.030 was shown to specifically target this toxic form of Tau and spare normal endogenous forms of the protein. We and our partners continue to drive innovation in the treatment and potential prevention of AD, developing new mechanisms of action and first-in-class potential therapeutics that are safe and simple to use for the hundreds of millions of people living with or at risk of the disease.”
James Spargo
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