ACI-35.030 Alzheimer's Disease Vaccine

ACI-35.030 Alzheimer's Disease vaccine candidate is designed to elicit antibodies against phosphorylated pathological Tau protein. It is designed to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy. The ACI-35.030 anti-pTau vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. pTau is a key component of Alzheimer's disease. It can be measured in plasma to identify who is at risk of developing Alzheimer's disease up to 20 years before the onset of clinical symptoms. Anti-pTau antibodies generated by ACI-35.030 can potentially reduce the spread and seeding of Tau pathology, a major hallmark of AD.

On February 11, 2021, Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "These remarkable data show that ACI-35.030 can generate unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response than a direct injection of exogenous antibodies." On November 30, 2022, AC Immune SA announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development.

LAUSANNE, Switzerland-based AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases.

ACI-35.030 Indication

ACI-35.030 Alzheimer's Disease (AD) vaccine candidate is indicated to reduce the spread and seeding of Tau pathology, a major hallmark of AD. Immunization with anti-Tau vaccines has become an essential strategy for treating AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030 is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 can potentially reduce the spread and seeding of Tau pathology throughout the brain, says the Company.

ACI-35.030 News 2020 - 2022

November 30, 2022 - The Company announced data presented at CTAD 2022 confirm the excellent clinical performance of the ACI-35.030 vaccine candidate. This new clinical data shows that ACI-35.030 has been selected for further development, representing significant progress for the anti-pTau vaccine candidate.

February 15, 2022 - AC Immune SA announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early AD. Results indicate that the induced immune response selectively targets pTau, as shown by an increase in the anti-pTau/anti-Tau IgG ratio 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 support ACI-35.030's favorable safety and tolerability profile, as no clinically relevant safety concerns have been observed.

August 31, 2021 - "The top-line results of the Lauriet Phase II clinical trial of semorinemab are remarkable in that it is the first time we have seen a therapeutic effect by a monoclonal anti-Tau antibody therapy," said Andrea Pfeifer, chief executive officer of AC Immune. "We also are excited that this is the first time a monoclonal antibody has had a therapeutic impact on cognition in the mild-to-moderate AD patient population."

February 11, 2021 - AC Immune's Alzheimer's Vaccine Generates Potent Anti-pTau Antibody Response in a Phase 1b/2a Study "These remarkable data show that ACI-35.030 is capable of generating unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response than a direct injection of exogenous antibodies. As pathological pTau is present as a precursor many years before Tau accumulation in the brain is detectable via brain imaging, such results highlight the significant promise of ACI-35.030 as an early intervention for AD, especially when combined with cutting-edge pTau diagnostics that would enable the identification of people at risk of developing Tau-driven disease.

We look forward to continuing to advance ACI-35.030 in our collaboration with Janssen Pharmaceuticals, Inc., as we aim to bring this potentially breakthrough vaccine to patients," said Prof. Andrea Pfeifer, CEO of AC Immune SA.

January 25, 2021 - Barron's article: The Covid-19 Vaccine Offers a Road Map for Tackling Dementia. Here's How.

July 16, 2020 - AC Immune SA announced initiating the second-highest dosing group in the Company's Phase 1b/2a clinical trial evaluating ACI-35.030 to treat Alzheimer's disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety, tolerability, and immunogenicity results from the initial dosing group.

May 4, 2020 - Dear Investor, 2020 continues to be an important and eventful year for AC Immune and the entire field of neurodegenerative diseases, even in the context of the challenges posed by the COVID-19 pandemic. With the publication of our Q1 2020 results, we have again confirmed our strong cash position of CHF 277.9 million. This provides the Company with a solid foundation and a cash runway extending through at least Q1 2024 without including any potential future milestone payments from partnerships. Moving forward, we remain on track to meet multiple value-creating milestones this year, with five clinical readouts expected. Of these readouts, we are particularly excited about the anticipated announcement of the first Phase 2 proof-of-concept data for semorinemab, an anti-Tau antibody, achieved through our partnership with Genentech, a member of the Roche group.

ACI-35.030 Alzheimer's Disease Vaccine Clinical Trials

ACI-35.030 clinical studies.

Clinical Trial NCT04445831: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Tau Targeted Vaccines in 56 Participants With Early Alzheimer's Disease - Last update posted on June 4, 2021. On November 12, 2021, AC Immune presented interim results for this Phase 1b/2a trial. 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).