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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
About this update from Ac Immune Sa
[{"type":"text","content":"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 LAUSANNE, Switzerland, Nov. 12, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today presented new interim Phase 1b/2a data on ACI-35.030, a first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate being developed in partnership with Janssen Pharmaceuticals, Inc., at the 14th Clinical Trials on Alzheimer's Disease (CTAD) conference, which is being held in Boston, Massachusetts from November 9-12, 2021. 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 Johannes Streffer gave an on-demand oral presentation featuring data from an ongoing, placebo-controlled Phase 1b/2a trial evaluating ACI-35.030 in participants with early Alzheimer’s disease (AD). Results from the trial show that ACI-35.030 treatment led to the strong induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, enriched paired helical filaments (ePHF). 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-35.030Anti-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-35.030The anti-ePHF IgG response was boosted following additional doses at weeks 8 and 24The ACI-35.030-induced immune response was lasting over an initial period of 26-weeks and showed class-switching from IgM to IgGInterim 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. Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “To see such a strong and ...