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Immune Response Shown in Alzheimer’s Vaccine

Brain activity graphic

(Gordon Johnson, Pixabay)

11 Feb. 2021. Results from a clinical trial show an experimental vaccine produces antibodies for breaking up harmful brain deposits in people with early Alzheimer’s disease. AC Immune SA in Lausanne, Switzerland, developer of the vaccine code-named ACI-35.030, reported today interim findings from the clinical trial, which are not yet peer-reviewed.

AC Immune develops diagnostics, vaccines, and treatments for Alzheimer’s disease and other neurodegenerative disorders. Alzheimer’s disease is a progressive neurodegenerative condition, the most common form of dementia affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as misfolded tangles of proteins inside brain cells known as tau. The company cites data from the World Alzheimer Reports showing an estimated 50 million people worldwide with dementia, a number expected to grow to 152 million by 2050.

AC Immune uses two separate technologies to address misfolded proteins, particularly tau that builds up inside of neurons in the brain, and spreads between cells, and amyloid-beta proteins that accumulate as plaques outside of neurons. One of those technologies, called SupraAntigen, is the basis for treatments that generate antibodies in the immune system for attacking and breaking up tau deposits, particularly before they cause irreversible damage to neurons.

ACI-35.030 is designed to generate antibodies seeking out deposits with phosphorylated tau, or pTau, often found in people with Alzheimer’s disease, or AD.  AC Immune is developing ACI-35.030 in partnership with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which has an exclusive license on the vaccine.

Measuring antibody concentrations with anti-pTau properties

The clinical trial is an early- and mid-stage study, enrolling 32 individuals, age 50 to 75, in the early stages of Alzheimer’s disease or with mild cognitive impairment, at six sites in Finland, the Netherlands, and the U.K. Participants are randomly assigned to receive low, medium, or high doses of ACI-35.030 or a placebo at predetermined intervals over 48 weeks, then followed for another 26 weeks.

The study team is looking primarily at the safety of ACI-35.030, watching for adverse effects including suicidal impulses, and changes in vital signs. But the researchers are also measuring immunoglobulin-G and -M antibody concentrations with anti-pTau properties in the blood of participants.

Early results from the trial, says AC Immune, show ACI-35.030 is safe and well-tolerated with no relevant safety issues observed so far. Blood samples show anti-pTau immunoglobulin-G and -M antibodies in all recipients of ACI-35.030, including recipients of one low or medium dose of ACI-35.030 with anti-pTau immunoglobulin-G antibodies. Moreover, high concentrations of anti-pTau immunoglobulin-G antibodies are found in ACI-35.030 recipients after a single dose.

The published findings do not indicate numbers of participants receiving ACI-35.030, nor any comparisons with placebo recipients. And the trial does not measure effects of ACI-35.030 on tau deposits on neurons in participants.

“As pathological pTau is present as a precursor many years before tau accumulation in the brain is detectable via brain imaging,” notes Andrea Pfeifer, CEO of AC Immune, in a company statement, “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.”

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Disclosure: The author owns shares in Johnson & Johnson.

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