Drugs / ACI-35.030
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04445831 | Jul 2019 → Sep 2023 | Alzheimer disease, brain disorder, cognitive impairment with or without cerebellar ataxia | AC Immune SA | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-09-25 | AC Immune SA | Results Peer-reviewed results from Phase 1b/2a Trial of Anti-pTau Active Immunotherapy from AC Immune Published in eBioMedicine acimmune.com ↗
Detailed results from completed Phase 1b/2a trial of ACI-35.030 and JACI-35.054 demonstrated that two different active immunotherapy formulations against the same target can induce a differential antibody response in individuals with early Alzheimer’s disease |
| 2025-01-08 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease jnj.com ↗
Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease |
| 2024-07-25 | AC Immune SA | Regulatory AC Immune’s ACI-35.030 (now “JNJ-2056”) Granted FDA Fast Track Designation for Alzheimer’s Disease acimmune.com ↗
AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the pathologic form of the Tau protein, phosphorylated Tau (pTau), has received Fast Track designation from the U.S. Food and Drug Administration (FDA). |
| 2024-02-22 | AC Immune SA | Results AC Immune Announces Upcoming Presentations at AD/PD™ 2024 acimmune.com ↗
ACI-35.030 Anti-phospho-Tau active immunotherapy produces antibodies that prevent pathological Tau seeding in vitro |
| 2022-11-30 | AC Immune SA | Results AC Immune’s Alzheimer’s Disease Vaccine-candidate ACI-35.030 Selected for Further Development acimmune.com ↗
The results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, ePHF. |
| 2022-11-23 | AC Immune SA | Results AC Immune to Present Progress of Alzheimer’s Disease Programs targeting Abeta and Tau at the 15th CTAD Conference acimmune.com ↗
We look forward to presenting at CTAD new data from our SupraAntigen ® anti-pTau vaccine ACI-35.030, highlighting its safety, tolerability and immunogenicity profile. |
| 2022-04-28 | AC Immune SA | Results AC Immune Reports First Quarter 2022 Financial Results and Provides Corporate Update acimmune.com ↗
Data from the high-dose cohort showed the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). |
| 2022-02-15 | AC Immune SA | Results AC Immune ACI-35.030 Phase 1b/2a Trial Interim Data Confirm Consistent Safety and Potent Immunogenicity of pTau Alzheimer’s Vaccine in High-dose Cohort acimmune.com ↗
New interim data from the Phase 1b/2a trial show that the high-dose of ACI-35.030 led to the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). |
| 2021-11-12 | AC Immune SA | Results AC Immune Announces Interim Phase 1b/2a Data Showing that its ACI-35.030 Anti-pTau Alzheimer’s Vaccine Generates a Potent Immune Response acimmune.com ↗
Results from the trial show that ACI-35.030 treatment led to the strong induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, enriched paired helical filaments (ePHF). |
| 2021-02-11 | AC Immune SA | Results AC Immune’s Alzheimer’s Vaccine Generates Potent Anti-pTau Antibody Response in a Phase 1b/2a Study acimmune.com ↗
ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD, achieving antibody levels several orders of magnitude higher than pre-vaccination levels. |
| 2020-07-16 | AC Immune SA | Results AC Immune Advances phospho-Tau Alzheimer’s Vaccine in Phase 1b/2a Study acimmune.com ↗
The decision to advance to the higher dosing group follows encouraging interim safety, tolerability and immunogenicity results from the initial dosing group. |
All press releases naming this drug 12 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ACI-35.030 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04445831 ↗ |