ACI-7104.056 - (VacSYn)

August 11, 2026: AC Immune SA (NASDAQ: ACIU) said the FDA granted Fast Track designation and cleared the IND for ACI-7104, its anti-alpha-synuclein active immunotherapy for early-stage Parkinson’s disease, allowing the ongoing Phase 2 VacSYn study to expand to U.S. sites.

The Fast Track decision was based on interim Part 1 Phase 2 data at 76 weeks. AC Immune said ACI-7104 was safe and well tolerated, with no clinically relevant safety issues, and met immunogenicity targets with a 100% responder rate. The company also said the interim data showed early signals of activity.

ACI-7104 is being studied in VacSYn, an adaptive, biomarker-based Phase 2 trial in patients with early-stage Parkinson’s disease. Full week-100 results from Part 1 remain expected in H2 2026.

AC Immune also noted a recent $4 million research grant from the Vijay and Marie Goradia Charitable Foundation to support an extension of Part 1 by an additional two years to assess longer-term safety and efficacy.