Name: UB 311
Therapy Type: Immunotherapy (active) (timeline)
Target Type: Amyloid-Related (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2)
Company: United Neuroscience
UB 311 is a synthetic peptide vaccine developed by United Neuroscience, a spin-off of United Biomedical. UB-311 couples a helper T-cell epitope designed with the United Biomedical's UBITh® platform to the Aβ1–14 sequence, packaged in a proprietary vaccine-delivery system. The approach aims to stimulate a T-helper type 2 regulatory immune response over a T-helper type 1 proinflammatory response, and to avoid cross-reactivity with similar endogenous antigens, i.e., autoimmune responses.
A peer-reviewed paper on preclinical studies in small animals, baboons, and macaques reported that the vaccine generated N-terminal anti-Aβ antibodies, which neutralized Aβ toxicity and promoted plaque clearance. The paper also claimed that the vaccine evoked no anti-Aβ cellular responses in a transgenic mouse model for AD, and that both acute and chronic dosing were safe and well-tolerated in cynomolgus macaques (Wang et al., 2007).
Clinicaltrials.gov lists a 2010/2011 Phase 1 safety, tolerability, and immunogenicity trial that was conducted in 19 people with mild to moderate Alzheimer's disease, 14 of whom continued into a long-term follow-up study. At two sites in Taiwan, three shots were administered intramuscularly at baseline, four weeks, and 12 weeks; the follow-up study observed participants out to 48 weeks. Results are not published in PubMed; however, a conference news story claims the vaccine was safe, well-tolerated, and produced a specific antibody response in all participants tested. This news report contains details about dosing, post-injection antibody titers, and other details (see Apr 2013 Medscape Medical News).
In October 2015, a Phase 2 trial at four sites in Taiwan started enrolling 45 people with a clinical diagnosis of mild Alzheimer's disease, a MMSE between 20 and 26, and a CDR of 0.5 or 1. This study compares two dosing regimens—three priming shots followed by two boosters, and three priming shots followed by four boosters—to placebo. Besides the primary outcomes of safety/tolerability and immunogenicity, this study also assesses cognitive, functional, global, and neuropsychiatric outcomes. It is set to run through 2017.
For all English-language clinical studies, see clinicaltrials.gov.
- Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. PubMed.
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