JACI-35.054 / AC Immune, J&J - LARVOL DELTA

AC Immune’s Tau-targeting therapy shows promise in early Alzheimer’s trial (PharmaTimes) - "ACI-35.030 demonstrated a rapid, potent and sustained polyclonal antibody response against pathological forms of Tau, including phosphorylated Tau (pTau) and brain-derived Tau (ePHF), after a single dose...All participants were classified as anti-pTau IgG responders within two weeks, with response rates between 94% and 100% maintained through week 74 in high-dose cohorts. The therapy also showed specificity, as antibody levels against normal Tau declined with subsequent doses...In contrast, JACI-35.054 produced a more variable response and required multiple administrations to reach consistent antibody levels. It also induced antibodies against normal Tau after the second dose, which increased with further treatment."

P1/2 data • Alzheimer's Disease

Safety and immunogenicity of two Tau-targeting active immunotherapies, ACI-35.030 and JACI-35.054, in participants with early Alzheimer's disease: a phase 1b/2a, multicentre, double-blind, randomised, placebo-controlled study. (PubMed, EBioMedicine) - P1/2 | "ACI-35.030 and JACI-35.054 were well tolerated. ACI-35.030 induced a more rapid and sustained antibody response selective to p-Tau species with evidence of altering AD-related plasma biomarkers and was selected for testing in the ongoing Phase 2b trial."

IO biomarker • Journal • P1/2 data • Alzheimer's Disease • CNS Disorders • Pain

ACI-35.030 anti-phospho-Tau active immunotherapy for the treatment of early Alzheimer's Disease (AD): Update from the Phase 1b/2a study data and perspectives. (CTAD 2023) - P1/2 | "Background: Two active immunotherapies, ACI-35.030 (liposomal formulation) and JACI-35.054 (conjugated formulation), targeting phosphorylated-Tau (pTau) are currently being tested in a Phase 1b/2a clinical trial (NCT04445831) to evaluate the safety, tolerability and immunogenicity of different doses of these clinical candidates. In general, the liposome-based active immunotherapy ACI-35.030 showed a better antibody profile in terms of rapid response, higher responder rate, homogeneity of the antibody response across study participants, epitope coverage and evidence of antibody maturation towards pathologic forms of Tau. ACI-35.030 has been selected to move into the next stage of clinical development in preclinical AD."

P1/2 data • Alzheimer's Disease • CNS Disorders • Dementia

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=57 | Completed | Sponsor: AC Immune SA | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Aβ42

ACI-35.030 and JACI-35.064, two novel anti-phospho-Tau vaccines for the treatment of Alzheimer’s Disease: Interim Phase 1b/2a data on safety, tolerability and immunogenicity (CTAD 2022) - P1/2 | "The clinical study is successfully ongoing despite the challenges of being performed during the restrictions of the Covid-19 pandemic demonstrating that vaccination with either ACI-35.030 or JACI-35.054 is safe and well tolerated, inducing IgG responses to the immunizing peptide as well as ePHF. However, overall ACI-35.030 emerges as the superior vaccine candidate in terms of responder rate, number of immunizations to achieve the initial antibody titer, homogeneity of the antibody response across subjects, epitope coverage, with evidence of antibody maturation towards pathologic forms of Tau. As both vaccines contain the same antigenic peptide sequence, the differences observed so far in antibody response can be ascribed to the different technologies used to present the antigenic peptide to the immune system."

Clinical • P1/2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Infectious Disease • Novel Coronavirus Disease

AC Immune’s Alzheimer’s Disease Vaccine-candidate ACI-35.030 Selected for Further Development (GlobeNewswire) - P1b/2a | N=57 | NCT04445831 | Sponsor: AC Immune SA | “AC Immune SA…announced that based on the Phase 1b/2a interim data, ACI-35.030…has been selected for further development….The results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, ePHF. The ACI-35.030-induced antibody response was sustained and could be periodically boosted over a period of 72 weeks. The vaccine candidate was generally well tolerated. The decision to select ACI-35.030 follows the comparison, presented at CTAD, demonstrating its strengths relative to a protein conjugate vaccine, JACI-35.054, an alternative anti-pTau vaccine also being evaluated in parallel in the Phase 1b/2 trial. ‘Looking forward into 2023 AC Immune will have three vaccine candidates in Phase 2 development...for neurodegenerative diseases.’”

New P2 trial • P1/2 data • Alzheimer's Disease • CNS Disorders • Dementia

AC Immune to Present Progress of Alzheimer’s Disease Programs targeting Abeta and Tau at the 15th CTAD Conference (GlobeNewswire) - "AC Immune SA...announced the upcoming presentations of its vaccine technology SupraAntigen®, and of its anti-Tau and anti-Abeta investigational candidates, at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, California (United States) and online, on November 29 – December 2, 2022. During the conference, Prof. Johannes Streffer, AC Immune’s Chief Medical Officer, will present interim data from the anti-phospho-Tau vaccine program currently in a Phase 1b/2a study. 'During the conference, Prof. Johannes Streffer, AC Immune’s Chief Medical Officer, will present interim data from the anti-phospho-Tau vaccine program currently in a Phase 1b/2a study.'...In addition, there will be presentations on fluid biomarkers covering partnered programs for the Phase 2 crenezumab anti-Abeta antibody and Phase 2 semorinemab anti-Tau antibody, both partnered with Genentech."

Biomarker • Clinical data • P1/2 data • P2 data • Alzheimer's Disease • CNS Disorders

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=57 | Active, not recruiting | Sponsor: AC Immune SA | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

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 (Yahoo Finance) - P1/2 | N=56 | NCT04445831 | Sponsor: AC Immune SA | “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 Alzheimer’s disease (AD)….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.”

P1/2 data • Alzheimer's Disease • CNS Disorders

AC Immune Announces Interim Phase 1b/2a Data Showing that its ACI-35.030 Anti-pTau Alzheimer’s Vaccine Generates a Potent Immune Response (GlobeNewswire) - P1/2, N=56; NCT04445831; Sponsor: AC Immune SA; "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)."

P1/2 data • Alzheimer's Disease • CNS Disorders

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: AC Immune SA; N=32 ➔ 56

Clinical • Enrollment change • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • MRI

AC Immune Reports First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Achieved and Anticipated 2021 milestones: ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose); JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose); ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2;"

P1/2 data • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Tauopathies And Synucleinopathies

AC Immune Reports Full-Year 2020 Financial Results and Provides 2021 R&D Outlook (Streetinsider.com) - "ACI-35.030 anti-pTau vaccine: Phase 1b/2a interim analysis in Q4 (highest dose)…JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)…Alpha-synuclein imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3...ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2...Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2...Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3..."

Clinical data • P1/2 data • P2 data • Trial completion • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies