ACI-7104.056 / AC Immune - LARVOL DELTA

HOW THE THERAPEUTIC APPROACH TO EARLY PARKINSON'S DISEASE WILL CHANGE IN THE NEXT FUTURE (ADPD 2025) - "Levodopa remains the most efficacious drug, a better preparation of levodopa like IPX 203 can ensure more stable plasma levels of Levodopa...Tavapadon is a new dopamine agonist stimulating D1-D5 receptors which concluded the phase III. Other compounds such as CVN424 (Cerevance) orally active and selective GPR6 inverse agonist, piperamat (IRLAB 752) a cortical enhancer to improve balance, Clenbuterol/Nadolol for cognition, mesdopetam a D3 antagonist are under investigation...These include the monoclonal antibody prasinezumab, UCB0599 and buntanetap small-molecules α-synuclein aggregation inhibitor, the vaccine ACI-7104.056 by AC immune...The LRKK2 kinase inhibitor BIIB122/DNL151 is in phase IIb in PD. BIAL BIA 28-6156 activator of the GCase enzyme is under investigation in patients with GBA mutation. The combination of symptomatic and disease modifying therapy, the use of accurate biomarkers and more precise treatment will be the future in the treatment of PD."

CNS Disorders • Movement Disorders • Parkinson's Disease • GBA

3440: INDUSTRY SYMPOSIUM 02 (NO CME/CPD CREDIT): Unlocking active immunotherapy for tailored prevention strategies in neurodegenerative diseases (ADPD 2025) - "Günther Staffler will present ACI-7104.056, an anti-a-syn active immunotherapy currently evaluated in the Phase 2 VacSYn trial in early PD...Lennert Steukers will then present the ReTain Phase 2b trial, the first prevention trial for an active immunotherapy in preclinical Alzheimer's, evaluating ACI-35.030/JNJ-2056, an anti-pTau active immunotherapy...Anke Post will provide an update on ACI-24.060, an anti-Abeta active immunotherapy being evaluated in the ABATE Phase 1b/2 trial in both early Alzheimer's disease (AD) and Down syndrome-associated Alzheimer's (DSAD). We will conclude with a Q&A to discuss how active immunotherapies, early detection and biomarker-driven strategies might reshape the future of prevention and treatment in Alzheimer's and Parkinson's diseases."

IO biomarker • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Genetic Disorders • Movement Disorders • Parkinson's Disease

TARGETING ALPHA-SYNUCLEIN IN EARLY PARKINSON'S DISEASE: ACI-7104.056 IN THE PHASE 2 TRIAL VACSYN (ADPD 2025) - "Supported by AC Immune"

P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease

AC Immune Reports Further Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease (GlobeNewswire) - P2 | N=150 | VacSYn (NCT06015841) | Sponsor: AC Immune SA | "AC Immune SA...announced additional interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson’s disease (PD)....Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after 2 immunizations and were further boosted by each additional immunization. Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average over 20-fold higher than the placebo background level after four immunizations. Based on further interim results to be reported later in 2025 including pharmacodynamic and biomarker data, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients."

P2 data • Trial status • Parkinson's Disease

AC Immune Announces Upcoming Presentations and Industry Symposium on Active Immunotherapies at AD/PD™ 2025 (GlobeNewswire) - "AC Immune SA...announced upcoming presentations highlighting its precision medicine pipeline at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2025) taking place in Vienna, Austria, on April 1 – 5, 2025. AC Immune will host an industry symposium highlighting advances in the clinical development of active immunotherapies featuring key opinion leaders, industry experts and AC Immune leadership."

Clinical data • Alzheimer's Disease • Parkinson's Disease

An update on immune-based alpha-synuclein trials in Parkinson's disease. (PubMed, J Neurol) - "Specifically, UB-312, AFFITOPE PD01A, PD03A and ACI-7104.056 are designed to provoke an immune response against α-syn (active immunisation), while Prasinezumab and Cinpanemab, MEDI1341 and Lu AF82422 focus on directly targeting α-syn aggregates (passive immunisation). Despite some promising results, challenges such as variable efficacy and trial discontinuations persist. Future research must address these challenges to advance disease-modifying therapies for PD around this therapeutic target."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

AC Immune Reports Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease (GlobeNewswire) - P2 | N=150 | VacSYn (NCT06015841) | Sponnsor: AC Immune SA | "Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after 2 immunizations and were strongly boostable. Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average 16-fold higher than the placebo background level after three immunizations. Based on further interim results to be reported in H1 2025 including pharmacodynamic data, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients."

P2 data • CNS Disorders • Parkinson's Disease

AC Immune Reports First Quarter 2024 Financial Results and Provides a Corporate Update (Yahoo Finance UK) - "ACI-7104.056 VacSYn Phase 2 trial of anti-a-syn active immunotherapy in Parkinson’s disease (PD) on track for safety and immunogenicity interim data in H2 2024...ACI-35.030 anti-pTau active immunotherapy First patient treated in ReTain Phase 2b clinical trial expected in the coming months..."

P2 data • Trial status • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Parkinson's Disease

ACI-7104.056, AN ACTIVE IMMUNOTHERAPY FOR SYNUCLEINOPAHTIES, INDUCES A STRONG AND SUSTAINED ANTIBODY RESPONSE AGAINST ALPHA SYNUCLEIN IN NON-HUMAN PRIMATES. (ADPD 2024) - P2 | "The evaluation of the phase 2 clinical stage ACI-7104.056 immunotherapy in a safety and immunogenicity study in NHP supports the use of this drug chronically in humans. The ability of elicited antibodies to interfere with the propagation of aSyn aggregates in living neurons further supports the development of ACI-7104.056 as a potential disease modifying therapy for PD and other synucleinopathies."

CNS Disorders • Movement Disorders • Parkinson's Disease

VACSYN STUDY: AN INNOVATIVE BIOMARKER-BASED PHASE 2 CLINICAL TRAIL TO EVALUATE ACI-7104.056, A NOVEL ACTIVE IMMUNOTHERAPY FOR PARKINSON'S DISEASE (ADPD 2024) - P2 | "With a focus on identifying treatment effects early through comprehensive biomarker and immunogenicity analyses and leveraging interim analyses of biomarker responses for informed decision-making, the VacSYn Phase 2 clinical study aims to assess the therapeutic potential of ACI-7104.056, priming the way for targeted interventions in PD management."

Biomarker • Clinical • IO biomarker • P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Active immunotherapy ACI-7104.056 in early PD: update from the Phase 2 trial VacSYn (ADPD 2024) - "Supported by AC Immune."

P2 data

INDUSTRY SYMPOSIUM (NO CME/CPD CREDIT): State-of-the-art of treatment and diagnosis of alpha-synuclein pathologies (ADPD 2024) - "Elpida Tsika who will focus on the development of Morphomer a-syn small molecule drugs, and Dr. Nuno Mendonça who will present an update from AC Immune's active immunotherapy targeting alpha-synuclein, ACI-7104.056, which is being evaluated in the Phase 2 clinical trial VacSYn. The session concludes with an interactive Q&A, providing attendees with the opportunity to engage directly with the speakers. Join us for a scientifically grounded exploration into the evolving landscape of treatments and diagnosis for alpha-synuclein pathologies."

CNS Disorders • Movement Disorders • Parkinson's Disease

AC Immune Reports Second Quarter 2023 Financial Results And Provides A Corporate Update (AC Immune Press Release) - "ACI-24.060 anti-Abeta active immunotherapy: Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in H2 2023; Interim safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023; Initial Abeta-PET data on amyloid plaque reduction in AD expected in H1 2024; ACI-7104.056 anti-a-syn active immunotherapy: Completion of recruitment of first cohort in the Phase 2 VacSYn study in Parkinson's disease expected in H2 2023; ACI-35.030 anti-pTau active immunotherapy: Initiation of next trial in AD expected in H2 2023 (to be followed by a milestone payment); Semorinemab anti-Tau antibody: Results from the open-label extension of the Phase 2 Lauriet trial in mild-to-moderate AD expected in H2 2023..."

Enrollment status • New trial • P1/2 data • P2 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease • Tauopathies And Synucleinopathies

AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases (GlobeNewswire) - "AC Immune’s wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy, to treat Parkinson’s disease (PD). Enrollment of cohort 1 in the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, is completed, with 16 patients randomized, and cohort 2 enrollment and randomization has begun. No safety concerns have been reported to date with no reports of moderate or severe adverse events. Safety and immunogenicity updates from the trial will be reported in H2 2024. ACI-35.030: AC Immune’s partnered investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau)....Under the terms of the licensing agreement, AC Immune has received a milestone payment of CHF15 million and expects to receive another milestone payment of CHF 25 million related to achieving an undisclosed enrollment target in 2025."

Enrollment closed • Licensing / partnership • P2 data • CNS Disorders • Parkinson's Disease

1st patient dosed in Phase 2 trial testing vaccine for Parkinson’s (Parkinson's News Today) - "The first patient has been dosed in a Phase 2 clinical trial testing AC Immune’s ACI-7104.056, an investigational vaccine targeting toxic alpha-synuclein forms to prevent nerve cell degeneration in Parkinson’s disease...AC Immune expects to complete the enrollment of the first group of patients in the VacSYn Phase 2 clinical trial (NCT06015841) and deliver initial safety findings by the year’s end...The study is now underway at several sites in Germany and Spain, and recruitment is ongoing at certain Spanish sites."

Enrollment status • Trial status • CNS Disorders • Parkinson's Disease

AC Immune Reports Third Quarter 2023 Financial Results and Provides a Corporate Update (GlobeNewswire) - "ACI-24.060 anti-Abeta active immunotherapy: Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in Q4 2023; First Abeta-PET data on amyloid plaque reduction in AD following 6 months of treatment expected in H1 2024; ACI-7104.056 anti-a-syn active immunotherapy: Completion of cohort 1 enrollment and initial safety findings in the Phase 2 VacSYn study in PD expected by year-end; ACI-35.030 anti-pTau active immunotherapy: Initiation of next trial in AD expected in Q4 2023 (to be followed by a milestone payment); Anti-TDP-43 antibody: Advancement of candidate into preclinical development (tox) expected in Q4 2023..."

New trial • P1/2 data • P2 data • Preclinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Parkinson's Disease

VacSYn: A Study to Evaluate the Effects of ACI-7104.056 Vaccination in Patients With Early Stages of Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: AC Immune SA

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

AC Immune at AD/PD 2023 to Present New Clinical and Preclinical Data from its Precision Medicine Pipeline (GlobeNewswire) - “AC Immune SA…announced that ten presentations will be delivered at the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PDTM 2023), taking place in Gothenburg, Sweden, and virtually, on March 28 – April 1, 2023. In addition, Johannes Streffer, M.D., Chief Medical Officer of AC Immune, will join an expert panel to discuss the latest developments in immunotherapies in Alzheimer’s disease. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, commented: ‘The ten presentations during this AD/PDTM conference demonstrate AC Immune’s progress towards our over-arching goal, which is to shift the treatment paradigm towards Precision Medicine and disease prevention. As our clinical programs in Alzheimer’s and Parkinson’s diseases are advancing, we are solidifying our position as a leading developer of vaccines for neurodegenerative diseases.’”

Biomarker • Clinical • Preclinical • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Parkinson's Disease

VACSYN STUDY DESIGN – BIOMARKER-BASED DEVELOPMENT FOR ACI-7104, A NOVEL CANDIDATE VACCINE FOR THE TREATMENT AND PREVENTION OF PARKINSON'S DISEASE (ADPD 2023) - "Successful development of disease -modifying approaches needs the translation of biological understanding into clinically meaningful measures. VacSYN is a clinical trial design that will allow informed and de -risked transition into pivotal studies."

Biomarker • IO biomarker • CNS Disorders • Developmental Disorders • Movement Disorders • Parkinson's Disease

ACI-7104: Data readout from P2 VACSYN trial for Parkinson’s disease in H2 2023 (AC Immune) - Investor Presentation

P2 data • CNS Disorders • Parkinson's Disease

AC Immune Reports Third Quarter 2022 Financial Results And Provides A Corporate Update (AC Immune Press Release) - "Received clearance for a clinical trial application to initiate an adaptive, biomarker-based Phase 2 study of the anti-a-syn vaccine ACI-7104 in patients with early Parkinson’s disease (PD). Initiation of the trial is expected in Q4 2022....The Company recognized CHF 0.3 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, an increase of less than CHF 0.1 million compared to the prior period."

Commercial • New P2 trial • Trial initiation date • CNS Disorders • Parkinson's Disease

AC Immune Reports Full Year 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "AC Immune SA...today reported its financial results for the year ended December 31, 2021, and provided a corporate update, highlighting progress in its broad pipeline of products to treat and diagnose neurodegenerative diseases....ACI-7104, the optimized formulation of PD01, is on track to enter Phase 2 testing in early PD patients in H2 2022."

New P2 trial • CNS Disorders • Parkinson's Disease

ACI-7104: Initiation of P2 trial for Parkinson’s disease in H2 2022 (AC Immune, 11th Annual SVB Leerink Global Healthcare Conference)

New P2 trial • CNS Disorders • Parkinson's Disease

ACI-7104: Initiation of P2 trial for Parkinson’s disease in H2 2022 (AC Immune, 11th Annual SVB Leerink Global Healthcare Conference)

New P2 trial • CNS Disorders • Parkinson's Disease

AC Immune Awarded Two Michael J. Fox Foundation Grants to Advance Small Molecule Parkinson’s Disease Programs (GlobeNewswire) - "AC Immune SA...today announced it has been awarded two grants, a total of approximately USD 1.5 million, from The Michael J. Fox Foundation for Parkinson’s Research (MJFF), to develop first-in-class brain penetrant small molecules targeting alpha-synuclein (a-syn) and the (NOD)-like receptor protein 3 (NLRP3) inflammasome pathway in Parkinson’s disease (PD)....The awarded programs complement AC Immune’s portfolio in PD, which covers the full spectrum of treatment modalities addressing a-syn, a well-characterized target in PD. It includes the Phase 2 ready anti-a-syn vaccine ACI-7104, as well as a next-generation positron emission tomography (PET) imaging tracer. AC Immune’s PD portfolio also includes a pre-clinical stage anti-a-syn antibody..."

Financing • CNS Disorders • Parkinson's Disease