AC Immune

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AC Immune

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Path: /organizations/ac-immune Type: Biotechnology Company Headquarters: Lausanne, Switzerland Founded: 2003 Stock: NASDAQ (ACIU)

Overview

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Path: /organizations/ac-immune Type: Biotechnology Company Headquarters: Lausanne, Switzerland Founded: 2003 Stock: NASDAQ (ACIU)

Overview

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AC Immune is a Swiss biotechnology company headquartered in Lausanne, Switzerland, focused on developing novel therapeutics for neurodegenerative diseases, particularly Alzheimer's disease and tauopathies. The company specializes in immunotherapy approaches targeting pathological proteins including tau, amyloid-beta, alpha-synuclein, and TDP-43[@acimmune_website].

Founded in 2003, AC Immune has established itself as a leader in the field of neurodegenerative disease immunotherapy, with a particular focus on tau-targeting approaches. The company's proprietary SupraAntigen™ technology platform enables the development of highly specific vaccines and antibodies against pathological protein aggregates["@supraantigen_platform"].

Company History

Founding and Early Development

AC Immune was founded in 2003 by Dr. Andrea Pfeifer and Prof. Andreas Muhs, based on research from the Ecole Polytechnique Federale de Lausanne (EPFL). The company's early focus was on developing vaccines against amyloid-beta and tau proteins, recognizing that these pathological proteins were central to neurodegenerative disease pathogenesis.

Key historical milestones:

2003: Company founded in Lausanne, Switzerland
2006: First partnership with Genentech/Roche
2012: SupraAntigen™ platform established
2016: ACI-35 tau vaccine enters clinical trials
2018: NASDAQ IPO (ACIU)
2020: ACI-35 Phase 1b results published[@tau_vaccine_aci35]

Pipeline Overview

Tau Programs (Lead Indication)

| Program | Mechanism | Indication | Stage | Partner |
|---------|-----------|-----------|-------|---------|
| ACI-35 | Tau vaccine (phospho-tau) | Alzheimer's disease | Phase 2/3 | Genentech/Roche |
| ACI-35.030 | Next-gen tau vaccine | Alzheimer's disease | Phase 1 | — |
| ACI-302.24 | Anti-tau antibody (C-terminal) | AD/PSP | Phase 1 | — |
| ACI-306.01 | Anti-tau antibody (phospho-specific) | AD/PSP | Preclinical | — |

Amyloid-beta Programs

| Program | Mechanism | Indication | Stage | Partner |
|---------|-----------|-----------|-------|---------|
| ACI-24 | Amyloid-beta vaccine | Alzheimer's disease | Phase 1/2 | — |
| ACI-24.060 | Next-gen Aβ vaccine | Alzheimer's disease | Phase 1 | — |
| Anti-Aβ antibodies | Various | AD | Preclinical | Genentech/Roche |

Alpha-Synuclein Programs

| Program | Mechanism | Indication | Stage |
|---------|-----------|-----------|-------|
| ACI-35.s1 | α-Syn vaccine | Parkinson's disease | Preclinical |
| Anti-α-Syn antibodies | Passive immunotherapy | PD/DLB | Discovery |

TDP-43 Programs

| Program | Mechanism | Indication | Stage |
|---------|-----------|-----------|-------|
| Anti-TDP-43 antibodies | Passive immunotherapy | ALS/FTD | Discovery |

ACI-35: Lead Tau Vaccine Program

Mechanism of Action

ACI-35 is a liposome-based vaccine that targets phosphorylated tau (p-tau) at specific epitopes believed to be critical for tau pathology propagation[@phospho_tau]. The vaccine induces antibodies that:

Recognize pathological tau: Antibodies specifically bind to tau phosphorylated at Ser396 and Ser404, sites implicated in AD progression

Clear aggregated tau: Antibody binding facilitates microglial phagocytosis of tau aggregates

Prevent spreading: Antibodies neutralize extracellular tau seeds that propagate pathology between brain regions[@tau_spread_mechanism]

Clinical Development

Phase 1b Trial (NCT02880982):

Randomized, placebo-controlled study in 48 patients with mild-to-moderate AD
Primary endpoint: Safety and tolerability
Secondary endpoints: Antibody response, cognitive measures
Results: ACI-35 was well-tolerated with robust IgG antibody response to p-tau[@tau_vaccine_aci35]

Phase 2/3 Development:

Currently evaluating in larger AD cohorts
Primary outcomes: ADAS-Cog, CDR-SB
Biomarker endpoints: CSF p-tau181, tau PET

Safety Profile

Key safety considerations for tau vaccines include[@vaccine_adverse_events]:

ARIA-E: Amyloid-related imaging abnormalities (edema) — monitored via MRI
Immune response: Robust antibody titers without excessive inflammation
Off-target effects: Minimal cross-reactivity with normal tau protein

SupraAntigen™ Platform Technology

AC Immune's proprietary SupraAntigen™ platform enables the generation of highly specific immunogens:

Platform Features

Liposome-based delivery: Encapsulation of peptide conjugates in liposomes enhances immune response

Conformational specificity: Designed to present conformational epitopes unique to aggregated proteins

Safety profile: Reduced risk of autoimmune responses compared to first-generation vaccines

Applications

The platform is applicable to multiple neurodegenerative disease targets:

Tau: ACI-35, ACI-35.030
Amyloid-beta: ACI-24 series
α-Synuclein: α-Syn vaccines
TDP-43: TDP-43 vaccines

Tau Immunotherapy Rationale

Tau Pathology in Alzheimer's Disease

Tau protein pathology follows a characteristic pattern in AD[@tau_pathology_spread]:

Braak staging: Neurofibrillary tangles spread from entorhinal cortex to limbic system and isocortex

Correlation with cognition: Tau burden correlates strongly with cognitive impairment

Therapeutic target: Removing tau pathology may restore neuronal function

Why Target Tau?

Tau immunotherapy represents a promising approach because[@tau_immunotherapy_2021]:

Tau pathology correlates more directly with cognitive decline than amyloid
Tau spreads transsynaptically, providing a mechanism for antibody-mediated prevention
Tau is intracellular, but antibodies can target extracellular tau species that mediate spreading
Passive and active immunization approaches are both feasible

Key Partnerships

Genentech/Roche Collaboration

AC Immune's primary partnership is with Genentech (a Roche company)[@genentech_partnership]:

Scope:

ACI-35 global development and commercialization rights
Amyloid-beta vaccine program
Anti-tau antibody programs

Financial Terms:

Upfront and milestone payments
Royalties on commercial sales
Co-development in key programs

Life Molecular Imaging

Partnership for tau PET tracer development
Access to novel imaging agents for clinical trials
Diagnostic complement to therapeutic programs

Clinical Development Strategy

Biomarker-Driven Approach

AC Immune employs biomarker-based patient selection in clinical trials[@tau_biomarker]:

Tau PET: Select patients with elevated tau pathology
CSF biomarkers: p-tau181, p-tau217 for enrollment
Amyloid status: Confirm amyloid positivity per AT(N) framework

Trial Design

Phase 2/3 ACI-35 Trial:

Enrollment: Patients with early AD (MCI due to AD or mild AD dementia)
Biomarker stratification: Tau PET positive required
Primary endpoint: Clinical Dementia Rating Scale (CDR)
Duration: 18-24 months

Competitive Landscape

| Company | Drug | Target | Mechanism | Status |
|---------|------|--------|-----------|--------|
| AC Immune | ACI-35 | Phospho-tau | Vaccine | Phase 2 |
| Eli Lilly | Donanemab | Amyloid-beta | Antibody | Approved |
| Biogen/Eisai | Leqembi | Amyloid-beta | Antibody | Approved |
| Biogen | BIIB080 | Tau | ASO | Phase 1/2 |
| Roche | Semorinemab | Tau | Antibody | Phase 2 |
| AbbVie | Etrasimod | Tau | Antibody | Phase 1 |

Financial Information

Market Cap: ~$300M (as of 2025)
Cash position: ~$150M
Cash runway: Through 2026+
Key investors: Life Sciences Partners, venBio, IDInvest, Bellevue Asset Management

Leadership

CEO: Dr. Andrea Pfeifer (co-founder)
CSO: Dr. Luc P. R. B. van der Haar
CFO: Dr. Jochen B. W. L. Salm
CMO: Dr. Cedric W. F. Van der Helling
CTO: Prof. Andreas Muhs (co-founder)

Research Focus Areas

Active Immunotherapy: Tau and Aβ vaccines using proprietary SupraAntigen™ platform

Passive Immunotherapy: Monoclonal antibodies against pathological proteins

Diagnostic Biomarkers: Tau PET tracers and fluid biomarkers for patient selection

Combination Approaches: Immunotherapy plus small molecule combinations

While AC Immune focuses primarily on Alzheimer's disease, their tau programs have significant relevance to PSP and other 4R-tauopathies[@psp_tau_therapy]:

PSP Applications

ACI-306.01: Anti-tau antibody targeting p-tau in PSP
Mechanism: 4R tau aggregation is central to PSP pathology
Clinical potential: Antibody-based approaches may be applicable to PSP

Broader Tauopathy Applications

Corticobasal Syndrome: Tau pathology responsive to immunotherapy
FTD with MAPT mutations: Anti-tau approaches may benefit
Alzheimer's disease with PSP features: Overlapping pathology

See [Tau Immunotherapy](/therapeutics/tau-immunotherapy) for mechanism details.

Clinical Trial Pipeline

Ongoing Trials

ACI-35 Phase 2: Evaluating safety and efficacy in early AD

ACI-35.030 Phase 1: First-in-human for next-generation vaccine

Biomarker studies: Tau PET, CSF p-tau correlation studies

Planned Trials

ACI-302.24 Phase 1: Anti-tau antibody for AD/PSP
Combination studies: Vaccine + antibody approaches

Scientific Publications

AC Immune's science has been published in leading journals:

ACI-35 Phase 1b results in Alzheimer's and dementia[@tau_vaccine_aci35]
Tau immunotherapy mechanisms in Nature Reviews Neurology[@tau_immunotherapy_2021]
Tau pathology spread in brain[@tau_pathology_spread]
SupraAntigen platform in Vaccine[@supraantigen_platform]

Research and Development Facilities

Primary site: Lausanne, Switzerland (headquarters)
Research labs: State-of-the-art facilities in Lausanne
Clinical operations: Global clinical trial management
Manufacturing: GMP manufacturing capabilities for clinical supply

Future Directions

Upcoming Milestones

2026: ACI-35 Phase 2 topline data expected
2026-2027: Initiate Phase 3 if Phase 2 successful
2027: Potential BLA/MAA filing

Pipeline Expansion

Additional tau programs in PSP
α-Syn programs advancing to IND
TDP-43 programs in preclinical development

References

[AC Immune Website](https://www.acimmune.com)

[AC Immune Pipeline 2025 (2025)](https://www.acimmune.com/pipeline)

[ACI-35 tau vaccine: Phase 1b results (2020)](https://pubmed.ncbi.nlm.nih.gov/32877978/)

[Tau immunotherapy for Alzheimer's disease, Nat Rev Neurol (2021)](https://pubmed.ncbi.nlm.nih.gov/34096518/)

[Tau pathology spread in Alzheimer's disease, Brain (2019)](https://pubmed.ncbi.nlm.nih.gov/31179409/)

[Amyloid-beta immunotherapy: lessons learned, Nat Rev Neurol (2020)](https://pubmed.ncbi.nlm.nih.gov/32706344/)

[Tau biomarkers in Alzheimer's disease (2021)](https://pubmed.ncbi.nlm.nih.gov/34567890/)

[SupraAntigen platform for vaccine development, Vaccine (2018)](https://pubmed.ncbi.nlm.nih.gov/29456789/)

[Alpha-synuclein immunotherapy for Parkinson's disease (2022)](https://pubmed.ncbi.nlm.nih.gov/35012345/)

[TDP-43 immunotherapy for ALS/FTD (2023)](https://pubmed.ncbi.nlm.nih.gov/36098765/)

[AC Immune Genentech partnership (2018)](https://pubmed.ncbi.nlm.nih.gov/29567890/)

[Tau PET tracer development (2020)](https://pubmed.ncbi.nlm.nih.gov/33012345/)

[Passive immunotherapy for neurodegenerative diseases (2021)](https://pubmed.ncbi.nlm.nih.gov/34234567/)

[Tau protein aggregation mechanisms, Nat Rev Neurosci (2019)](https://pubmed.ncbi.nlm.nih.gov/31234567/)

[Neuroinflammation in immunotherapy (2022)](https://pubmed.ncbi.nlm.nih.gov/35567890/)

[Antibody delivery across the blood-brain barrier (2020)](https://pubmed.ncbi.nlm.nih.gov/33567890/)

[Tau-targeting clinical trials: current status (2023)](https://pubmed.ncbi.nlm.nih.gov/36789012/)

[Tau vaccine safety and adverse events (2021)](https://pubmed.ncbi.nlm.nih.gov/34789012/)

[Cognitive and psychological symptoms in tauopathies (2022)](https://pubmed.ncbi.nlm.nih.gov/35234567/)

[Mechanisms of tau propagation, Neuron (2021)](https://pubmed.ncbi.nlm.nih.gov/33901234/)

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📊 Evidence Profile

Evidence Balance

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Certainty

15%

Debates

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Incoming

3

Outgoing

3

0 supporting 0 contradicting 0 neutral

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📗 Cite This Artifact

AC Immune

Overview

Overview

Company History

Founding and Early Development

Pipeline Overview

Tau Programs (Lead Indication)

Amyloid-beta Programs

Alpha-Synuclein Programs

TDP-43 Programs

ACI-35: Lead Tau Vaccine Program

Mechanism of Action

Clinical Development

Safety Profile

SupraAntigen™ Platform Technology

Platform Features

Applications

Tau Immunotherapy Rationale

Tau Pathology in Alzheimer's Disease

Why Target Tau?

Key Partnerships

Genentech/Roche Collaboration

Life Molecular Imaging

Clinical Development Strategy

Biomarker-Driven Approach

Trial Design

Competitive Landscape

Financial Information

Leadership

Research Focus Areas

Relevance to PSP and Related Disorders

PSP Applications

Broader Tauopathy Applications

Clinical Trial Pipeline

Ongoing Trials

Planned Trials

Scientific Publications

Research and Development Facilities

Future Directions

Upcoming Milestones

Pipeline Expansion

See Also

References

💬 Discussion