Interim data confirm the promising safety, tolerability and Tau-specific immunogenicity observed in the previous clinical study
ACI-35.030 is a clinical stage vaccine generated with the proprietary SupraAntigen™ platform addressing proteinopathies across neurodegenerative diseases
Immunization with anti-Tau vaccines has become an important strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030, which is being developed in collaboration with
This Phase 1b/2a trial is a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 over a 48-week treatment phase in patients with early AD. Other endpoints will assess clinical and cognitive parameters as well as additional immunogenicity and safety parameters.
The ACI-35.030 anti-pTau vaccine is the second vaccine under investigation generated from AC Immune’s SupraAntigen™ platform, along with ACI-24, a proprietary anti-amyloid beta (Abeta) vaccine currently in Phase 1b/Phase 2 clinical development in two separate indications. The Company’s pipeline is also advancing two monoclonal antibodies, semorinemab, an anti-Tau antibody in Phase 2 development and crenezumab, an anti-Abeta antibody in Phase 2 development, both partnered with
ACI-35.030 is a potent liposomal anti-pTau active investigational vaccine designed to elicit antibodies against phosphorylated pathological Tau protein, in order to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy.
It builds on the success of AC Immune’s ACI-35 vaccine, which demonstrated an early target-specific antibody response against pTau after the first injection in the vast majority of patients in a Phase 1b study in mild-to-moderate AD. In preclinical studies, ACI-35.030 retained the excellent non-clinical safety profile and the highly specific antibody response against phosphorylated pathological Tau produced by ACI-35, while demonstrating an enhanced and more homogeneous antibody response.
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Source: AC Immune SA