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AC Immune Reports 'Positive Interim Results' from Novel Phase 1b/2a Alzheimer's Vaccine Trial

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Shares of AC Immune SA traded 15% higher after the firm reported that interim results from the Phase 1b/2a Alzheimer's trial of its ACI-35.030 vaccine demonstrated generation of potent anti-phospho-Tau antibody responses in 100% of older patients with early Alzheimer's disease.

Switzerland-based clinical-stage biopharmaceutical firm AC Immune SA (ACIU:NASDAQ) today announced "positive interim results from its ongoing Phase 1b/2a clinical trial evaluating its first-in-class anti-phospho-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer's disease (AD)."

The company highlighted that "the 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." The firm indicated that there were not any clinically relevant adverse events observed in the study and that the results achieved support its plans to further develop and move the Alzheimer's vaccine into Phase 2/3.

The company stated that immunization with anti-Tau vaccines is a novel approach in treating AD and other neurodegenerative diseases and claimed that "ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain."

AC Immune's CEO Professor Andrea Pfeifer stated, "These remarkable data show that ACI-35.030 is capable of generating unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response compared to direct injection of exogenous antibodies. As pathological pTau is present as a precursor many years before Tau accumulation in the brain is detectable via brain imaging, such results highlight the significant promise of ACI-35.030 as an early intervention for AD, especially when combined with cutting-edge pTau diagnostics that would enable identification of people at risk of developing Tau-driven disease."

"We look forward to continuing to advance ACI-35.030 in our collaboration with Janssen Pharmaceuticals Inc., as we aim to bring this potentially breakthrough vaccine to patients," Pfeifer added.

The firm noted that the interim findings from the Phase 1b/2a trial showed anti-Tau IgG response preferentially targets phosphorylated Tau in all patients with 100% of patients demonstrating an anti-pTau IgG response after the first injection for both lowest and second highest dose amounts.

The firm explained that the Phase 1b/2a pTau AD Vaccine Trial enrolled 32 patients with early AD who were given different doses of ACI-35.030 over 48 weeks. Patients were randomized in the multicenter, double-blind, placebo-controlled clinical study to assess safety, tolerability and immunogenicity of different dosage levels.

The company indicated that it is developing the ACI-35.030 vaccine together in partnership with Janssen Pharmaceuticals and described ACI-35.030 a being "a potent liposomal anti-pTau active investigational vaccine designed to elicit antibodies against phosphorylated pathological Tau protein that is designed to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy."

AC Immune is a clinical-stage biopharmaceutical company based in Lausanne, Switzerland, that specializes in developing precision medicines for treating neurodegenerative diseases. The firm stated it "utilizes two proprietary discovery platforms, SupraAntigen™ and Morphomer™, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins." The company noted that at present its drug pipeline includes nine therapeutic and three diagnostic product candidates, and that six of those are currently being investigated in ongoing clinical trials. The company listed that is now actively collaborating on research projects with several well-known major pharmaceutical companies including Eli Lilly and Co., Janssen Pharmaceuticals and Roche Group's Genentech.

AC Immune began the day with a market cap of about $524.4 million with around 71.74 million shares outstanding and a short interest of about 1.5%. ACIU shares opened 59% higher today at $11.62 (+$4.31, +58.96%) over yesterday's $7.31 closing price. The stock has traded today between $7.96 and $12.50 per share and is currently trading at $8.44 (+$1.13, +15.46%). [NLINSERT]

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