Nov. 4 at 3:54 PM
$ACIU AC Immune Pipeline Overview – Key Clinical Candidates & Anticipated H2 2025 Data based on published Q3 financials with multiple impactful data readouts to occur in Q4
AC Immune is advancing a diversified pipeline targeting neurodegenerative diseases with multiple clinical-stage candidates spanning active immunotherapies and next-generation diagnostic PET tracers. The company focuses on Alzheimer’s disease (AD), Parkinson’s disease (PD), and other proteinopathies such as FTD, ALS, and TDP-43-mediated disorders. Its approach leverages proprietary platforms like SupraAntigen and Morphomer to selectively target pathological protein forms without affecting healthy physiological proteins.
With several compounds currently in mid-to-late stage clinical development and high-value partnerships in place (e.g., Takeda, Janssen, Life Molecular Imaging), AC Immune is entering a pivotal period. Multiple clinical programs are expected to generate meaningful interim and Phase 1 data readouts in the second half of 2025 (H2 2025), adding significant potential value inflection points across therapeutic and diagnostic segments.
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✅ Clinical Pipeline & Expected H2 2025 Readouts
1. ACI-24.060 – Active Immunotherapy for AD & Down Syndrome (DS)
• Indication: Alzheimer’s Disease & DS with brain amyloid (PET+)
• Mechanism: Induces anti-Abeta antibodies; avoids Th-cell autoimmunity
• Trial: ABATE Phase 1b/2 (NCT05462106), 3 escalating dose cohorts in AD and DS
• Patients: AD & DS populations; several dozen patients treated to date (exact number not reported)
• Status: Well tolerated, strong immunogenicity, no ARIA-E events
• Partnership: Takeda (
$100M upfront; up to
$2.1B in milestones)
• H2 2025 Event: Possible additional cohort-level immunogenicity/amyloid-PET reduction data
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2. ACI-7104.056 – Active Immunotherapy Targeting α-Synuclein (PD)
• Indication: Early-stage Parkinson’s Disease
• Trial: Phase 2 VacSYn (NCT06015841)
• Patients: 30+ enrolled in Part 1; up to 150 possible in Part 2
• Status: Robust 20x anti-αsyn antibody response vs placebo; no safety signals
• H2 2025 Event: Interim data including pharmacodynamic biomarker findings; potential Part 2 start
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3. ACI-35.030 / JNJ-2056 – Anti-pTau Immunotherapy for Early AD
• Indication: Preclinical AD with confirmed Tau pathology
• Trial: Phase 2b ReTain (NCT06544616), potentially registrational
• Patients: ~500 planned over 4 years
• Status: Phase 1b/2a showed rapid and durable anti-pTau antibody response; FDA Fast Track
• H2 2025 Event: No confirmed readout, but possible interim biomarker review
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4. PI-2620 – Tau PET Diagnostic Agent for AD & Other Tauopathies
• Indications: AD, PSP, CBD
• Trial: Phase 3 pivotal study (NCT05641688), ≥52 patients analyzed in earlier Phase 2
• Status: Differentiated Tau imaging shown; Fast Track designated
• H2 2025 Event: No confirmed data release scheduled
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5. ACI-15916 – Next-Gen α-Synuclein PET Diagnostic
• Indication: Parkinson’s Disease
• Trial: Phase 1 in PD initiated Q1 2025
• Status: Optimized for higher target occupancy vs first-gen ACI-12589
• H2 2025 Event: First Phase 1 clinical readout
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6. ACI-19626 – First-in-Class TDP-43 PET Tracer
• Indication: ALS, FTD-TDP, possible AD subtypes
• Trial: Phase 1 initiated Q1 2025 in healthy and patient cohorts
• Status: High selectivity and brain penetration; strong preclinical binding in FTLD-TDP
• H2 2025 Event: Interim Phase 1 results expected
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Good luck longs, holding my position for Q4 readouts to occur by year end!
(this is not intended for financial advise, please do your own research)
