AC Immune SA · NASDAQ:ACIU

AC Immune SA — CTAD 2021 (Clinical Trials on Alzheimer's Disease), Boston

15 slides from AC Immune SA's conference presentation, November 2021

  1. Slide 1: ACI-35.030, a novel anti-phospho Tau vaccine for Alzheimer's Disease: Interim data

    ACI-35.030, a novel anti-phospho Tau vaccine for the treatment of Alzheimer’s Disease: Interim data on safety, tolerability and immunogenicity 1,2 1 1 1 1 1 Johannes Streffer , Bénédicte Lê , Olivier Sol , Marija Vukicevic , Emma Fiorini , Eva Gollwitzer , Valérie 1 1 1 1 1 1 Hliva , Julien Mermoud

  2. Slide 2: Disclaimer

    Disclaimer This presentation contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include s

  3. Slide 3: Aβ plaques accelerate Tau spreading and Tau-related cognitive decline in human AD

    Aβ plaques accelerate Tau spreading and Tau-related cognitive decline in human AD Congdon et al., Nature Reviews Neurology, 2018 Busche et al., Nature Neuroscience, 2020 Relation to study measures: Antibodies against: Non-phosphorylated Tau protein Phosphorylated Tau protein Enriched Paired Helical

  4. Slide 4: Targeting Amyloid Plaques and Pathological Tau with Immunotherapy

    Targeting Amyloid Plaques and Pathological Tau with Immunotherapy Biologicals: Vaccines and monoclonal antibodies Proprietary SupraAntigen® platform SupraAntigen®-V Target antigen (B-cell peptide) Liposomal anchor Adjuvant 1 (Palmitic chains) Vaccines: Active immunization T-cell (immune system produ

  5. Slide 5: ACI-35 (1st generation – pre-clinical)

    ACI-35 (1st generation – pre-clinical) Strong phospho-Tau specific antibody response in pre-clinical species, with staining of pathological Tau aggregates on transgenic mouse brain sections Taupir Staining (d35) ACI-35 in Tau.P301L mice pTau IgG titers pTau specificity (d35) Theunis et al., PlosONE,

  6. Slide 6: ACI-35 (1st generation – clinical)

    ACI-35 (1st generation – clinical) Phase 1b study in Alzheimer’s disease ■ Double-blind, randomized, placebo-controlled study for the safety, tolerability and immunogenicity of ACI-35 in patients with mild to moderate Alzheimer’s disease ■ Safe and well-tolerated at all doses and treatment regimens

  7. Slide 7: 2nd generation of the anti-pTau vaccine: ACI-35.030

    2nd generation of the anti-pTau vaccine: ACI-35.030 Addition of Tau independent T-cell epitope to increase immunogenicity in Rhesus monkeys Anti-pTau & anti-Tau peptide IgG titers 1×10 5 ** 1×10 4 Endpoint titer 1×10 3 ns 1×10 2 1×10 1 u u au au Ta Ta T T p ti- p ti- 1st gen. ACI-35 ti- ti- an an an

  8. Slide 8: 2nd generation of the anti-pTau vaccine: ACI-35.030

    2nd generation of the anti-pTau vaccine: ACI-35.030 Addition of Tau independent T-cell epitope to increase immunogenicity in Rhesus monkeys Immunostaining of Human cortical brain tissue AD Donor ■ Second generation ACI-35 results in Rhesus monkeys ■ Strong prime, boost and maintenance of antibody re

  9. Slide 9: Phase 1b/2a study ACI-35-1802

    Phase 1b/2a study ACI-35-1802 Study design for Cohort 1 (ACI-35.030 or placebo) W0 W8 W24 W48 Vaccine injection Treatment period Safety Follow-up Weeks 0 - 50 up to Week 74 Sub-coh.1.1: ACI-35.030 low dose or placebo W0 W8 W24 W48 Treatment period Safety Follow-up Sub-coh.1.2: ACI-35.030 mid dose or

  10. Slide 10: Good safety and tolerability

    Good safety and tolerability Sub-cohort 1.1 & 1.2 (Data cut end of September 2021) ■ ACI-35.030 was safe and well tolerated with no study vaccine-related safety concerns observed to date ■ No withdrawals due to adverse events ■ No adverse events of severe intensity ■ Two SAEs considered unlikely rel

  11. Slide 11: High response rate as early as 2 weeks post first vaccination

    High response rate as early as 2 weeks post first vaccination Sub-cohort 1.1 Sub-cohort 1.2 Week 2 Week 10 Week 2 Week 10 Week 26 Anti-Tau IgG 83.3% 33.3% 83.3% 100% 50% Anti-pTau IgG 100% 100% 100% 100% 100% Anti-ePHF IgG 66.7% 83.3% 100% 100% 100% ■ High responder rates after first and all followi

  12. Slide 12: ACI-35.030 induces potent antibody response with preference for pathological species

    ACI-35.030 induces potent antibody response with preference for pathological species Fast, high, phospho-Tau-specific, and boost-able antibody response Non-Phosphorylated Tau Phosphorylated & Pathological Tau species a n t i- p T a u Ig G t it e r s a n t i- e P H F Ig G t it e r s a n t i- T a u Ig

  13. Slide 13: Safe and potent anti-Tau Vaccine

    Safe and potent anti-Tau Vaccine Optimized SupraAntigen® vaccine delivering superior results ■ ACI-35 is a clinical stage Tau vaccine generating target/phospho-Tau-specific antibody response ■ ACI-35 optimized formulation engages safely target-unrelated T-cells to enhance and maintain antibody respo

  14. Slide 14: We want to thank the study participants, their families and caregivers

    We want to thank the study participants, their families and caregivers for their participation and commitment, as well as all Investigators and Site personnel for their active participation and support. ACIU – CTAD Boston – November 2021 © 2021 AC Immune. Not to be used or reproduced without permiss

  15. Slide 15: AC Immune

    AC Immune We continue to shape the future of neurodegeneration by discovering and developing breakthrough therapies through pioneering science and precision medicine ACIU – CTAD Boston – November 2021 © 2021 AC Immune. Not to be used or reproduced without permission 15

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