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LAUSANNE - AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company with a market capitalization of $270 million, announced that peer-reviewed results from its completed Phase 1b/2a trial of anti-pTau active immunotherapy have been published in eBioMedicine, according to a company press release. The company’s stock has shown strong momentum, gaining over 37% in the past six months, according to InvestingPro data.
The study demonstrated that ACI-35.030, developed using AC Immune’s SupraAntigen technology, generated rapid and potent polyclonal responses against pathological forms of Tau protein after the first dose in participants with early Alzheimer’s disease. No clinically relevant safety or tolerability issues were reported. While the company maintains a healthy balance sheet with more cash than debt and a current ratio of 1.33, InvestingPro analysis indicates rapid cash consumption requires monitoring.
The trial compared two different active immunotherapy formulations targeting the same phosphorylated Tau (pTau) peptide sequence. ACI-35.030 required only one injection to induce antibody titers in all participants, while the alternative formulation JACI-35.054 needed multiple administrations to reach consistent titers.
All participants across all dose levels were considered responders to ACI-35.030 within two weeks of treatment. In the two high-dose cohorts, response rates remained between 94% and 100% until week 74.
An exploratory post-hoc analysis showed that the two highest doses of ACI-35.030 resulted in significant changes from baseline in plasma pTau and brain-derived Tau plasma levels compared to placebo at multiple time points.
Based on these results, ACI-35.030 (also known as JNJ-64042056) was selected for further clinical testing and is now being investigated in the ongoing Phase 2b ReTain trial. This potentially registration-enabling study will include approximately 500 participants with preclinical Alzheimer’s disease and is being conducted at more than 40 clinical sites across the U.S., Japan, UK, and Australia.
The ReTain trial is fully funded and conducted by Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, under a global license agreement with AC Immune.
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