AC Immune’s ACI-35.030 (now called JNJ-2056), an active-immunotherapy candidate targeting the pathologic form of the Tau protein, has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
Based in Lausanne, AC Immune is a clinical-stage biopharmaceutical company specializing in precision medicine for neurodegenerative diseases. The company’s technologies, SupraAntigen® and Morphomer®, support a diverse pipeline of first- and best-in-class therapeutic candidates.
The investigational drug JNJ-2056, derived from AC Immune’s SupraAntigen® platform, aims to generate broad-spectrum protective antibodies against pathological Tau. This approach may reduce Tau aggregation and slow disease progression in Alzheimer’s patients. In clinical studies, JNJ-2056 has shown promise by inducing a strong antibody response against pathological Tau forms.
The FDA’s Fast Track designation acknowledges the potential of AC Immune’s therapy to provide significant benefits to patients. Andrea Pfeifer, CEO of AC Immune SA, stated, “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.”
Innovative solutions for Alzheimer’s disease and neurodegenerative disorders
The development of JNJ-2056 is being conducted under a global license agreement with Janssen Pharmaceuticals, Inc. Janssen is fully funding and conducting the Phase 2b ReTain trial, which is currently recruiting participants with preclinical Alzheimer’s disease who have not yet shown clinical symptoms.
This new milestone builds on AC Immune’s previous achievements, including a significant partnership with Takeda for the ACI-24.060 immunotherapy. With the continued advancement of its therapeutic pipeline, AC Immune remains at the forefront of innovative solutions for Alzheimer’s disease and other neurodegenerative disorders. The company’s efforts aim to provide new hope for millions of patients and their families worldwide.
