Switzerland-based clinical-stage biopharmaceutical company AC Immune SA (ACIU:NASDAQ), which develops precision medicines for neurodegenerative diseases including Alzheimer's, today announced "the initiation of the second highest dosing group in the company's Phase 1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer's disease (AD)." The firm noted that it has made the decision to advance the higher dosing group in the study after it received data that confirmed positive safety, tolerability and immunogenicity results from the initial dosing group in the trial.
The company stated that "immunization with anti-Tau vaccines has become an important strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology." The firm advised that it is developing ACI-35.030 in collaboration with Janssen Pharmaceuticals, a Johnson & Johnson (JNJ:NYSE) company, and noted that ACI-35.030 is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain.
The company's CEO Professor Andrea Pfeifer remarked, "The fact that ACI-35.030 shows encouraging safety and immunogenicity at the lowest dose in this elderly patient population is highly meaningful and we look forward to quickly enrolling this next dosing group."
"Tau-targeted approaches may have a much broader therapeutic window to potentially disrupt, slow or prevent disease progression at both early and advanced disease stages. Pathological pTau occurs early in the disease process, years before accumulation of Tau deposits. Therefore, our pTau-targeting approach holds significant promise for the treatment of AD at different disease stages," CEO Pfeifer added.
The company identified ACI-35.030 as "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."
The firm indicated that the Phase 1b/2a clinical study's main goal is to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 in early AD patients over a period of 48 weeks.
The company stated that "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."
AC Immune is headquartered in Lausanne, Switzerland, and is a clinical-stage biopharmaceutical company that specializes in developing precision medicines for treating neurodegenerative diseases. The firm stated that "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 outlined that its drug pipeline currently includes nine therapeutic and three diagnostic product candidates, and that five of those are presently being investigated in ongoing clinical trials.
AC Immune began the day with a market capitalization of around $516.7 million with approximately 71.86 million shares outstanding. ACIU shares opened 50% higher today at $10.82 (+$3.63, +50.49%) over yesterday's $7.19 closing price and reached a new 52-week high price this morning of $13.00. The stock traded today between $8.22 and $13.00 per share and closed at $8.55 (+$1.36, +18.92%).
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