AC Immune ACI-35.030 Phase 1b/2a Trial Interim Data Confirm Consistent Safety and Potent Immunogenicity of pTau Alzheimer’s Vaccine in High-dose Cohort
Observed strong induction of antibodies specific for pathological forms of Tau with ACI-35.030 treatment
ACI-35.030 continues to be well tolerated with no clinically relevant safety concerns observed in low-, mid- or high-dose cohorts to date
Interim data support plans for further late-stage development
ACI-35.030, based on AC Immune’s SupraAntigen® platform, is the first AD vaccine candidate designed to generate antibodies targeting pathological pTau in the brain. New interim data from the Phase 1b/2a trial show that the high-dose of ACI-35.030 led to the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). These data are consistent with those previously announced for the trial’s mid-dose cohort that showed median anti-pTau antibody titers increasing from baseline by two orders of magnitude at week 2 after a first injection.
Additional key findings from the high-dose interim analysis include:
- Results indicate that the induced immune response selectively targets pTau, as shown by an increase in the anti-pTau/anti-Tau IgG ratio over time up to week 10.
- In this interim data set to week 10, median levels of antibodies reactive with pathological Tau (ePHF) were boosted with both the first and second vaccine injections.
- Safety data provide further support for ACI-35.030’s favorable safety and tolerability profile, as no clinically relevant safety concerns have been 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 generate additional immunogenicity and safety data.
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.
The pTau vaccine candidate is being developed in collaboration with
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,
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