Previous interim results showing strong safety and potent immunogenicity support trial expansion and advancement of ACI-35.030 into Phase 2b/3
Alternative vaccine candidate also advances to second highest dose group based on encouraging interim results
Interim results from the low and second highest dose groups of the Phase 1b/2a trial showed that ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD with no clinically relevant safety concerns observed to date. These data, as well as additional interim Phase 1b/2a results, will be presented at an upcoming medical congress.
Long-term immunization with vaccines represents a valuable strategy for treatment and potentially prevention of AD and other neurodegenerative diseases. ACI-35.030 is the first AD vaccine candidate designed to generate antibodies that specifically target pathological pTau proteins in the brain. Anti-pTau antibodies generated continually in the body by ACI-35.030 have the potential to reduce and prevent the spread and seeding of Tau pathology, which is a major hallmark of AD.
In addition to ACI-35.030,
AC Immune is developing ACI-35.030 and JACI-35.054 in collaboration with
About the SupraAntigen™ platform
AC Immune’s clinically validated SupraAntigenTM platform uses proprietary liposomes to rapidly generate novel vaccines (SupraAntigen™-V) for active immunization as well as best-in-class monoclonal antibodies (SupraAntigen™-A) for passive immunization against key neurodegenerative disease targets. Antibodies generated by the platform are highly specific for the pathological conformations of misfolded proteins and have shown strong safety. The SupraAntigen™ platform has successfully generated two vaccines and two antibody candidates that have been validated in clinical studies and has led to multiple global partnerships with world-leading pharmaceutical companies. In addition to targeting Amyloid-beta and Tau,
About the Phase 1b/2a pTau AD Vaccine Trial
The Phase 1b/2a study is a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 and JACI-35.054 in patients with early AD. Secondary objectives will assess additional immunogenicity parameters, while exploratory endpoints will include notable biomarkers of progression of AD as well as clinical assessments. This Phase 1b/2a study evaluating ACI-35.030 and JACI-35.054 was initiated in Q3 2019 and is currently ongoing.
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