Watch for FDA meeting outcomes in early 2027 and Part 2 trial design details, which will be key catalysts for Phase 3 entry decision. The 100% immunogenicity rate and CSF penetration are strong de-risking signals for this active immunotherapy program.
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Executive Summary
AC Immune reported positive week-100 safety and immunogenicity data from Part 1 of the VacSYn Phase 2 trial of ACI-7104 in early-stage Parkinson's disease. All primary endpoints were met, with 100% antibody response after three immunizations and robust CSF penetration. The data support advancement to Part 2, with FDA discussions planned for early 2027.
Key Facts
- All primary endpoints (safety, tolerability, immunogenicity) met in Part 1 of VacSYn Phase 2 trial of ACI-7104
- 100% of patients developed antibodies against the a-syn target antigen after three immunizations
- Robust antibody penetration into cerebrospinal fluid observed in all patients
- Exploratory signals for target engagement and correlation between antibody levels and disease activity measures
- FDA discussions for Part 2 design expected early 2027
- Trial continues with Part 1 2-year extension and Part 2 expansion planned
Financial Impact
No financial data reported; clinical-stage company with no revenue from ACI-7104. Positive Phase 2 data supports pipeline value and potential future partnership milestones.
Risk Factors
- Part 1 was not designed for clinical efficacy; Part 2 must demonstrate clinical activity to support Phase 3
- Small sample size (34 patients) limits statistical power of exploratory biomarker and clinical correlations
- Regulatory pathway and Part 2 design are not yet finalized; FDA feedback could alter development timeline
- No financial data in filing; company remains pre-revenue with reliance on partnerships and funding
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001651625-26-000020 |
| Document: aciu-20260923x6k.htm | 0001651625-26-000020 |
| Document: 0001651625-26-000020-index-headers.html | 0001651625-26-000020 |
| Document: 0001651625-26-000020-index.html | 0001651625-26-000020 |
| Document: 0001651625-26-000020.txt | 0001651625-26-000020 |
Filters
| Type | Now | ||||
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Oct 9, 2026 17d ago | 3/A | $2.45 $2.40 | ▼ −2.04% | ▼ −2.03% | $2.31 (−5.71%) |
Oct 9, 2026 17d ago | 3 | $2.50 $2.45 | ▼ −2.00% | ▼ −1.94% | $2.31 (−7.60%) |
Oct 2, 2026 24d ago | 6-K | $2.73 $2.71 | ▼ −0.55% | ▼ −1.22% | $2.31 (−15.23%) |
Sep 23, 2026 4w ago | 6-K | $2.83 $2.66 | ▼ −6.01% | ▼ −5.92% | $2.31 (−18.37%) |
Sep 3, 2026 7w ago | 6-K | $2.93 $2.86 | ▼ −2.39% | ▼ −2.00% | $2.31 (−21.16%) |
Aug 20, 2026 9w ago | 6-K | $2.64 $2.90 | ▲ +9.85% | ▲ +9.44% | $2.31 (−12.50%) |
Aug 20, 2026 9w ago | Press Release | $2.64 $2.90 | ▲ +9.85% | ▲ +9.44% | $2.31 (−12.50%) |
Aug 11, 2026 10w ago | 6-K | $2.54 $2.62 | ▲ +3.15% | ▲ +2.90% | $2.31 (−9.06%) |
Aug 11, 2026 10w ago | Press Release | $2.54 $2.62 | ▲ +3.15% | ▲ +2.90% | $2.31 (−9.06%) |
Aug 5, 2026 11w ago | 6-K | $2.29 $2.32 | ▲ +1.31% | ▲ +1.47% | $2.31 (+0.87%) |
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