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UB‐311, a novel UBITh ® amyloid β peptide vaccine for mild Alzheimer's disease
Open accessAbstract
Introduction: A novel amyloid β (Aβ) synthetic peptide vaccine (UB‐311) has been evaluated in a first‐in‐human trial with patients of mild‐to‐moderate Alzheimer's disease. We describe translational research covering vaccine design, preclinical characterization, and phase‐I clinical trial with supportive outcome that advances UB‐311 into an ongoing phase‐II trial. Methods: UB‐311 is constructed with two synthetic Aβ 1–14 –targeting peptides (B‐cell epitope), each linked to different helper T‐cell peptide epitopes (UBITh ® ) and formulated in a Th2‐biased delivery system. The hAPP751 transgenic mouse model was used to perform the proof‐of‐concept study. Baboons and macaques were used for preclinical safety, tolerability, and immunogenicity evaluation. Patients with mild‐to‐moderate Alzheimer's disease (AD) were immunized by intramuscular route with 3 doses of UB‐311 at weeks 0, 4, and 12, and monitored until week 48. Safety and immunogenicity were assessed per protocol, and preliminary efficacy was analyzed by Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS‐Cog), Mini–Mental State Examination (MMSE), and Alzheimer's Disease Cooperative Study–Clinician's Global Impression of Change (ADCS‐CGIC). Results: UB‐311 covers a diverse genetic background and facilitates strong immune response with high responder rate. UB‐311 reduced the levels of Aβ 1–42 oligomers, protofibrils, and plaque load in hAPP751 transgenic mice. Safe and well‐tolerated UB‐311 generated considerable site‐specific (Aβ 1–10 ) antibodies across all animal species examined. In AD patients, UB‐311 induced a 100% responder rate; injection site swelling and agitation were the most common adverse events (4/19 each). A slower rate of increase in ADAS‐Cog from baseline to week 48 was observed in the subgroup of mild AD patients (MMSE ≥ 20) compared with the moderate AD subgroup, suggesting that UB‐311 may have a potential of cognition improvement in patients with early stage of Alzheimer's dementia. Discussion: The UBITh ® platform can generate a high‐precision molecular vaccine with high responder rate, strong on‐target immunogenicity, and a potential of cognition improvement, which support UB‐311 for active immunotherapy in early‐to‐mild AD patients currently enrolled in a phase‐II trial ( NCT02551809 ).
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“Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials:”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [63]
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“Lu AF20513 epitope vaccine is estimated in a phase 1 study in mild AD.63”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [63]
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Metadata
- Authors
- Wang, C. Y., Wang, P., Chiu, M., Finstad, C. L., Lin, F., Lynn, S., Tai, Y., De Fang, X., Zhao, K., Hung, C., Tseng, Y., Peng, W., Wang, J., Yu, C., Kuo, B., & Frohna, P. A.
- Affiliations
- United Biomedical (United States) (US)
- Taipei Veterans General Hospital (TW)
- National Taiwan University Hospital (TW)
- United Biomedical Inc. Asia (UBI‐Asia) Hsinchu Taiwan
- United Biomedical, Inc. (UBI) Hauppauge NY USA
- United Neuroscience, Inc. (UNS) Hsinchu Taiwan
- Corresponding author
- Wang, Chang Yi
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2017-04-14
- Volume
- 3
- Issue
- 2
- Pages
- 262-272
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC5651432
- OpenAlex
- W2605942834
- Cited by
- 150
- References
- 52
- Citations by year
- 2026: 13 · 2025: 17 · 2024: 19 · 2023: 19 · 2022: 20 · 2021: 18 · 2020: 20 · 2019: 16 · 2018: 7
- FWCI
- 8.69
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- United Biomedical, Inc., Hauppauge, New York
- United Biomedical, Inc., Asia, Taiwan
- Ministry of Economic Affairs Grant, Taiwan
- UBITh AD Immunotherapeutic Vaccine [UB-311] (98-EC-17-A-20-1-0014)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- Alzheimer's disease, mild to moderate Alzheimer's disease, B-cell epitopes, helper T cell epitopes, immunogenicity, vaccine safety, amyloid plaques, baboons, macaque
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