ACI-7104.056 / AC Immune - LARVOL DELTA

AC Immune Reports Positive Safety & Immunogenicity at week-100 in Part 1 of VacSYn Phase 2 Trial of ACI-7104 (Yahoo Finance) - "The primary endpoints for Part 1 of the VacSYn trial of ACI-7104 were safety, tolerability and immunogenicity, all of which were met. ACI-7104 was generally safe and well-tolerated and shown to be strongly immunogenic, with 100% of patients developing antibodies against the immunizing a-syn target antigen PD01 after three immunizations...Part 1 of VacSYn was not designed for biomarker or clinical outcomes evaluation; however, additional exploratory analyses included monitoring the impact of ACI-7104 treatment on certain biomarkers (such as total a-syn and Neurofilament Light chain in the CSF), as well as clinical measures of disease activity....The final design of Part 2 is being consolidated and will be submitted to the FDA for review, with meetings expected early in 2027."

Clinical protocol • FDA event • P2 data • Parkinson's Disease

AC Immune SA...announced that it has received Fast Track designation and clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson's disease (PD). (Yahoo Finance) - "Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance....The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson's disease, with final Part 1 week-100 results on track to be announced in H2."

Fast track • IND • P2 data • Parkinson's Disease

AC Immune to Receive Research Grant from Goradia Family for Development of ACI-7104 in Parkinson’s Disease (GlobeNewswire) - "The grant will support extending Part 1 of the ongoing Phase 2 VacSYn trial of ACI-7104, AC Immune’s anti-alpha-synuclein (a-syn) active immunotherapy, in early Parkinson’s disease (PD)...The long-term dataset enabled by this grant will be particularly valuable for individuals with prodromal and early PD, who will likely require prolonged treatment and are expected to benefit from a well-established long-term safety profile....Final results from Part 1 of the trial (to week-104) are expected in H2 2026."

Financing • P2 data • Parkinson's Disease

Progress of Immunotherapies in Parkinson's Disease. (PubMed, CNS Neurosci Ther) - "Although current α-syn-targeted immunotherapies have shown limited clinical efficacy, ongoing advances in precision immunotherapy and individualized intervention strategies may help overcome existing therapeutic bottlenecks. This review provides a strategic framework for the future development of disease-modifying therapies for PD."

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

Q1 2026 and Subsequent Highlights (GlobeNewswire) - "Final results for the week 104 full data set from Part 1 of the VacSYn trial expected to be reported in H2 2026....Morphomer-Tau aggregation inhibitors Initiation of IND-enabling studies: H1 2026...Morphomer a-syn aggregation inhibitor Lead declaration: H1 2026."

P2 data • Pipeline update • Preclinical • Alzheimer's Disease • Parkinson's Disease

Stabilizing the progression of Parkinson's disease with active immunotherapy: Interim results of the Phase 2 VacSYn trial of ACI-7104.056 (ADPD 2026) - "Supported by AC Immune."

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

INDUSTRY SYMPOSIUM 04 (NO CME/CPD CREDIT): From Treatment to Prevention in Parkinson's Disease (ADPD 2026) - "ACI-7104.056 is an active immunotherapy targeting pathological α-synuclein, and interim Phase 2 results from the VacSYn trial provide early evidence consistent with stabilization of disease progression. Complementing this, Morphomer® small molecules target α-synuclein intracellularly, while novel biofluid-based diagnostics enable detection of pathological α-synuclein before symptom onset, and, together, create the conditions for intervention at the earliest disease stages.This symposium presents an integrated framework spanning early detection, immune-mediated clearance, and direct molecular intervention, making the case that preventing progression is a realistic therapeutic goal."

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

Full Year 2025 and Subsequent Highlights (The Manila Times) - "Approaching multiple value-inflection points, including interim results of the AD3 cohort in the Phase 2 ABATE trial of ACI-24 in Alzheimer’s disease in H1 2026, and full 24-month data from Part 1 of the Phase 2 VacSYn trial of ACI-7104 in Q3 2026...Investigational New Drug (IND)-enabling studies are expected to begin in H1 2026."

P2 data • Preclinical • Alzheimer's Disease • Parkinson's Disease

AC Immune focused its attention on various clinical plans that remain unaffected... (FierceBiotech) - "...including interim 12-month results from a phase 1b/2 study of its other Alzheimer’s bet, an anti-amyloid-beta vaccine dubbed ACI-24.060. There are also final data coming down the track from the first part of a phase 2 study of the anti-alpha-synuclein immunotherapy ACI-7104.056 in Parkinson’s disease. Both of those readouts are due this year, according to the biotech’s filing."

P1/2 data • P2 data • Alzheimer's Disease • Parkinson's Disease

AC Immune Positive Interim Phase 2 Data on ACI-7104.056 Support Potential Slowing of Progression of Parkinson’s Disease (The Manila Times) - "ACI-7104.056 induced a robust antibody response against the immunizing a-syn target antigen with a 100% responder rate. At week 76, two weeks after the sixth immunization, antibody titers in serum were over 500-fold higher than in the placebo group...Titers against the immunizing a-syn target antigen increased with successive immunizations, showing ACI-7104.056 generates antibodies that cross the blood-brain barrier...Total CSF a-syn levels in the treatment arm stabilized while as expected in the placebo group levels of a-syn in the CSF decreased over time (post-hoc analysis p=0.018)...Levels of NfL in the CSF remained stable in the ACI-7104.056 group and increased in the placebo group....Final data from Part 1 of the VacSYn trial are expected in mid-2026."

P2 data • Parkinson's Disease

VacSYn: A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: AC Immune SA | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

AC Immune Reports Third Quarter 2025 Financial Results and Provides a Corporate Update (GlobeNewswire) - "IND/CTA filing for small molecule NLRP3 inhibitor ACI-19764 and the start of IND-enabling studies for Morphomer-Tau aggregation inhibitor both expected by year-end...'We are now moving towards multiple value-inflection points. Further interim results from Part 1 of the VacSYn trial of ACI-7104.056, our wholly owned anti-alpha-synuclein active immunotherapy for Parkinson’s disease, are expected this quarter.'...'This technology also powers our ACI-24.060 anti-Abeta active immunotherapy program, for which additional results are expected in H1 next year.'...TDP-43-PET tracer: Initial Phase 1 readout in genetic frontotemporal dementia (FTD): Q4 2025....ACI-15916 a-syn-PET tracer: Phase 1 readout in Parkinson’s disease (PD): Q4 2025."

Clinical data • IND • Alzheimer's Disease • Frontotemporal Lobar Degeneration • Parkinson's Disease

AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Three active immunotherapies for precision prevention of neurodegeneration progressing through Phase 2 clinical development; ACI-7104.056 anti-alpha-synuclein active immunotherapy in Parkinson’s disease produced strong immunogenicity and favorable safety profile in interim results from the ongoing Phase 2 VacSYn...with further data to come in H2 2025; Third Alzheimer’s disease cohort (AD3) in the Phase 2 ABATE trial of anti-Abeta ACI-24.060 to reach 12 months of treatment in December 2025, with interim results expected early 2026....'We also expect to file an IND for ACI-19764 this year.'"

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

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