AC Immune Announces Interim Phase 1b/2a Data Showing that its ACI-35.030 Anti-pTau Alzheimer’s Vaccine Generates a Potent Immune Response
Observed strong induction of antibodies specific for pathological forms of Tau with ACI-35.030 treatment
New data presented at 14th CTAD conference support ACI-35.030’s advancement into late-stage development
ACI-35.030 is the first AD vaccine candidate designed to generate antibodies targeting pathological pTau in the brain. At CTAD, AC Immune’s Chief Medical Officer
Additional key findings from the CTAD presentation include:
- Anti-pTau IgG titers increased by two orders of magnitude from baseline already two weeks after the first injection of the mid-dose of ACI-35.030
- Anti-ePHF IgG titers increased by one order of magnitude from baseline as early as two weeks after the second injection at week 8 of the mid-dose of ACI-35.030
- The anti-ePHF IgG response was boosted following additional doses at weeks 8 and 24
- The ACI-35.030-induced immune response was lasting over an initial period of 26-weeks and showed class-switching from IgM to IgG
- Interim safety data further support ACI-35.030’s favorable safety and tolerability profile, with no clinically relevant safety concerns observed to date.
As previously announced, the ongoing Phase 1b/2a study has been expanded to include a total of 24 AD participants in the mid-dose sub-cohort. This expansion was designed to support the advancement of ACI-35.030 into late-stage development.
About the SupraAntigen® platform
AC Immune’s clinically validated SupraAntigen® 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 dosages of ACI-35.030 and JACI-35.054 in participants 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.
AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features ten therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP and RU. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, and NO.
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Source: AC Immune SA