AC Immune(US:ACIU)2025-12-11 15:02Summary of AC Immune Conference Call - December 11, 2025 Company Overview - Company: AC Immune (NasdaqGM: ACIU) - Focus: Development of active immunotherapies for neurodegenerative diseases, particularly targeting alpha-synuclein in Parkinson's disease and tau/amyloid-beta in Alzheimer's disease [4][27] Key Industry Insights - Parkinson's Disease: Second most common neurodegenerative disorder, fastest growing neurological disease, affecting approximately 1% of the population over 65 years [9] - Market Need: Significant unmet need for disease-modifying therapies in Parkinson's disease, with current treatments primarily symptomatic [28] Core Points from the Call 1. Vaccine Phase Two Trial Results: - Positive interim results from the phase two trial of ACI-7104, an anti-alpha-synuclein active immunotherapy for early Parkinson's disease patients [2][24] - The trial included 34 subjects aged 40-75 with early-stage Parkinson's disease [13] 2. Safety and Tolerability: - ACI-7104 demonstrated a favorable safety profile with no serious adverse events related to the study drug [24] - Common adverse events included injection site reactions (56%), headache (14%), and fatigue (12%) [15] 3. Immunogenicity: - ACI-7104 achieved a 100% responder rate, with significant increases in antibody titers observed after each immunization [16][24] - Antibodies generated were shown to cross the blood-brain barrier, indicating potential efficacy in targeting alpha-synuclein in the brain [17] 4. Biomarker Analysis: - Interim analysis showed stabilization of total alpha-synuclein levels in cerebrospinal fluid (CSF) in the treatment group, suggesting target engagement [25] - Neurofilament light chain (NFL) levels remained stable in the treatment group, indicating a potential slowing of neurodegeneration [20] - DaT-SPECT imaging indicated no progression in dopamine transporter levels in the treatment group, contrasting with expected declines in the placebo group [21][32] 5. Clinical Measures: - MDS-UPDRS Part III scores, which assess motor symptoms, showed minimal changes in the treatment group over 74 weeks, suggesting stabilization of motor function [23][30] 6. Future Development Plans: - AC Immune is considering an accelerated development pathway towards registration, potentially skipping part two of the trial [46] - Plans to include U.S. sites in future studies and explore the inclusion of tracer molecules in the next study [47] Additional Insights - Market Potential: Partner programs have generated over CHF 450 million in payments, with potential for an additional CHF 4 billion in milestone payments and royalties [5] - Long-term Vision: AC Immune aims to pioneer precision prevention strategies for neurodegenerative diseases, leveraging their active immunotherapy platform [27] Conclusion - The interim results from the ACI-7104 trial indicate promising safety, immunogenicity, and potential disease-modifying effects in early Parkinson's disease, positioning AC Immune favorably in the neurodegenerative disease market [26][50]