AC Immune SA (NASDAQ:ACIU) has released encouraging interim results from the on-going Phase 1b/2a clinical trial studying its first-in-class anti-phospho-Tau vaccine candidate ACY-35.030 in treating Alzheimer’s disease.
ACI-35.030 generated antibody response against pTau
Results indicated that the ACI-35.030 vaccine generated a strong antigen-specific antibody response against pTAU in 100% of subjects with AD. Similarly, the vaccine achieved antibody levels that were several orders higher compared to pre-vaccination levels. Most importantly, there weren’t any clinically relevant adverse events reported. The company and its strategic partners Janssen Pharmaceuticals Inc. are optimistic that the first two dosing cohorts’ preliminary findings support their plans to advance ACI-35-030 development for AD treatment.
Anti-Tau vaccinations show a proprietary treatment strategy for AD and other neurodegenerative disorders characterized by Tau pathology. Interestingly, ACI-35-030 has been designed to trigger a specific antibody response against pTau proteins in the brain with the anti-pTau antibodies generated by the vaccine having the potential of reducing Tau pathology seeding and spreading, which is a key AD hallmark.
The result offers promising clinical support for ACI-35.030, which utilizes a new vaccine formulation to trigger active immunization that will significantly improve antibody responses in patients with possibly attenuated immune systems. Fascinatingly, anti-pTau vaccination triggers antibody responses with pharmacokinetic features and targets epitopes differing considerably from semorinamab, the company’s anti-Tau monoclonal antibody. Therefore, this demonstrates the complementary and comprehensive nature of the company’s anti-Tau pipeline.
ACI-35.030 shows the potential of being an early AD intervention
AC Immune SA CEO Ander Pfeifer said remarkable data shows that the ACI-35.030 vaccine can potentially generate unprecedented antibody response against pTau in old people with high antigen-specific titers. Pfeifer said that the vaccine generated a stronger antibody response relative to direct exogenous antibody injection. He added since pathological pTau is an ever-present precursor before Tau accumulation in the brain easily detectable through imaging, these results show considerable promise of ACI-35.030 being an early Alzheimer’s disease intervention, more so when combined with the latest pTau diagnostics that will permit the identification of individuals at risk of having pTau driven diseases.