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Regulatory press release

ALZ-101 immunization generates sustained plasma IgG and predictable CSF antibody levels against neurotoxic oligomers

Alzinova
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Alzinova AB (Nasdaq First North: ALZ) announces new data showing that its vaccine candidate ALZ-101 generates sustained antibody levels in plasma and detectable levels in the cerebrospinal fluid. This supports the therapeutic potential of ALZ-101 by demonstrating exposure to the central nervous system, a key requirement for treating Alzheimer’s disease.

Alzinova has previously reported that Alzheimer’s patients treated with six doses of its anti-oligomer vaccine, ALZ-101, for at least 12 months maintain high steady-state levels of plasma IgG antibodies targeting neurotoxic amyloid-beta (Aβ) oligomers, key pathogenic drivers of Alzheimer’s disease. Newly analyzed cerebrospinal fluid (CSF) data from a subset of patients now reveals detectable IgG antibodies also in the central nervous system (CNS), with CSF levels reaching at least 0.3% of those in blood. This CSF-to-plasma ratio aligns with benchmarks observed in passive monoclonal antibody therapies, reinforcing ALZ-101’s potential to achieve therapeutic antibody exposure in the brain. Further characterization of CSF antibody kinetics is ongoing.

Tord Labuda, CEO of Alzinova AB, comments:
”We are very pleased to confirm that antibody titers are detectable in the central nervous system at levels comparable to other Alzheimer’s immunotherapies, and that sustained antibody exposure against relevant species—such as toxic Aβ oligomers in the brain—has been achieved. This not only demonstrates the therapeutic potential of ALZ-101 but also significantly strengthens the value of our underlying asset by providing evidence of central nervous system engagement.”

For further information, please contact:
Tord Labuda, CEO
E-mail: info@alzinova.com

About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AβCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the disease with great accuracy. From a global perspective, Alzheimer's disease is one of the most common and devastating neurological diseases, with around 40 million affected today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com

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ALZ-101 immunization generates sustained plasma IgG and predictable CSF antibody levels against neurotoxic oligomers

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