AC Immune’s ACI-35.030 granted FDA Fast Track Designation

AC Immune announced that its active-immunotherapy candidate, ACI-35.030, now called JNJ-2056, targeting the pathologic form of the Tau protein, phosphorylated Tau, has received Fast Track designation from the U.S. Food and Drug Administration. 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 Alzheimer’s disease, 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.”