Alzheimer's Disease Vaccines, Testing, and Treatments 2022
According to the Alzheimer's Association, Alzheimer's (AZD) is a degenerative brain disease caused by complex brain changes following cell damage. It leads to dementia symptoms that gradually worsen over time.
The most common early symptom of Alzheimer's is trouble remembering new information because the disease typically impacts the part of the brain associated with learning first, writes the U.S. NIH. Although most people with Alzheimer's are 65 and older, it is not a normal part of aging. In fact, the U.S. CDC says 'about 200,000 people 65 years and younger live with early-onset AZD.
Early-onset AZD is still a mystery; however, a genetic component has been identified. When Alzheimer's is caused by these genes, it is called "familial Alzheimer's disease." About 25% of all Alzheimer's disease is familial.
As of May 27, 2022, the U.S. FDA had not authorized preventive Alzheimer's vaccines.
Alzheimer's Disease Vaccine Candidates 2022
AADvac1 is a therapeutic vaccine candidate for Alzheimer's disease that targets misfolded tau protein, a common denominator of neurofibrillary pathology.
ACI-24 is an amyloid-beta (Abeta) vaccine wholly owned by AC Immune and derived from the Company's SupraAntigen® platform. It is designed to prevent Abeta plaque accumulation and enhance plaque clearance by generating antibodies against pathological Abeta, including oligomeric Abeta and pyroGlu-Abeta. AC Immune will be initiating clinical testing of the optimized ACI-24 formulation in 2022.
ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. AC Immune is collaborating with Janssen Pharmaceuticals, Inc.
Alzheimer's Disease Antibody Treatment Candidates 2022
Vaxxinity's UB-311 is an immunotherapeutic vaccine candidate targeting toxic forms of aggregated amyloid-beta in the brain to treat Alzheimer's disease. Phase 1, Phase 2a, and Phase 2a LTE trials have shown UB-311 to be highly immunogenic with a high responder rate and antibodies that bind to the desired target.
Aduhelm is an amyloid beta-directed antibody injection of 100 mg/mL for intravenous use indicated to treat Alzheimer's disease.
ProMIS' therapeutic product candidate PMN310 is a monoclonal therapeutic antibody designed to treat AD.
Alzamend Neuro, Inc.'s AL001 is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline, and salicylate to treat Alzheimer's and other neurodegenerative diseases and psychiatric disorders. It is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia-related to mild, moderate, and severe cognitive impairment associated with Alzheimer's.
Prothena Corporation's PRX012 is a next-generation, high-binding potency antibody designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for AD patients and caregivers. The U.S. FDA granted Fast Track Designation on April 26, 2022.
Alzinova AB's ALZ-101 is an active, therapeutic oligomer-specific vaccine candidate that stimulates the production of antibodies against the toxic Aβ oligomers. The first-in-human study in patients with early Alzheimer's disease was initiated in 2021. Topline data for the study is anticipated in the second half of 2023.
Alzheimer's Disease Testing News 2022
The U.S. FDA permitted marketing on May 4, 2022, for Fujirebio Diagnostics, Inc. Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test, intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
Alzheimer's Disease Treatment, Testing, & Vaccine News 2022
May 5, 2022 - Alzamend Neuro, Inc. announced the first patient with mild to moderate Alzheimer's had been dosed in a Phase IIA study for dementia related to Alzheimer's.
May 2, 2022 - Vaxxinity, Inc. announced that UB-311 was granted Fast Track designation by the U.S. FDA to treat Alzheimer's disease.
April 28, 2022 - Alzinova AB announces that the Data and Safety Monitoring Board completed a planned assessment of the ongoing ALZ-101 Phase 1b clinical study and recommended continuing the study.
April 26, 2022 - Prothena Corporation plc announced that the U.S. FDA granted Fast Track designation for PRX012, a potential best-in-class anti-amyloid beta (Aβ) antibody therapy for treating Alzheimer's disease.
April 26, 2022 - The four-year BrainHOPE project will use brain imaging and a range of tests to compare brain health in mid-life former footballers with members of the general population. This new study builds on the FIELD study, which found the risk of dementia and related disorders among former professional footballers was around 3.5 times higher than expected.
April 20, 2022 - The journal Nature published: Somatic genomic changes in single Alzheimer's disease neurons. 'Our results suggest that known pathogenic mechanisms in Alzheimer's disease may lead to genomic damage to neurons that can progressively impair function. The aberrant accumulation of DNA alterations in neurodegeneration provides insight into the cascade of molecular and cellular events in the development of Alzheimer's disease.'
April 5, 2022 - The journal Nature Neuroscience published a study: Genetic variants associated with longitudinal changes in brain structure across the lifespan. Gene set findings implicate both early brain development and neurodegenerative processes in the rates of brain changes. Identifying variants involved in structural brain changes may help determine biological pathways underlying optimal and dysfunctional brain development and aging.
April 4, 2022 - The journal Nature Genetics published a study that performed a two-stage genome-wide association study totaling 111,326 clinically diagnosed/‘proxy' AD cases. They found 75 risk loci, of which 42 were new at the analysis time. Pathway enrichment analyses confirmed the involvement of amyloid/tau pathways and highlighted microglia implications. Gene prioritization in the new loci identified 31 genes suggestive of new genetically associated processes, including the tumor necrosis factor-alpha pathway through the linear ubiquitin chain assembly complex.
March 30, 2022 - Alzinova AB announced its drug substance manufacturing partner, Bachem (Switzerland), had optimized the manufacturing process of the active ingredient in ALZ-101, a vaccine in clinical development for the treatment of Alzheimer's disease.
March 28, 2022 - Alzamend Neuro, Inc. announced that it had received the full data set from its Phase 1 clinical trial for AL001. These data affirmed that dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma indicate that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product, and the shapes of the lithium plasma concentration versus time curves are similar. AL001 salicylate plasma concentrations were well-tolerated and consistently within safe limits, and the safety profiles of AL001 and the marketed lithium carbonate capsule were benign. These data will help Alzamend establish doses for a planned Phase 2 multiple ascending dose studies in Alzheimer's disease patients.
March 28, 2022 - Prothena Corporation plc announced that the U.S. FDA had cleared the investigational new drug application for PRX012, a potential best-in-class anti-amyloid beta antibody in development for AD treatment.
March 23, 2022 - The Alzheimer's Association published a Research Article: Midlife lipid and glucose levels are associated with Alzheimer's disease. High-density lipoprotein (HDL) cholesterol and triglyceride levels were linked with Alzheimer's dementia decades later in life. The risk of Alzheimer's dementia fell by 15.4% during early adulthood (ages 35 to 50) for every 15 mg/dL increase in HDL cholesterol, reported Xiaoling Zhang, MD, Ph.D., of Boston University School of Medicine and co-authors in Alzheimer's & Dementia.
March 22, 2022 - ProMIS Chief Development Officer Dr. Johanne Kaplan delivered an oral presentation entitled: "Optimizing vaccine design for Alzheimer's disease: selective targeting of computationally-derived conformational B cell epitopes of soluble amyloid-beta toxic oligomers." The presentation discussed the design of an amyloid-beta (Aβ) vaccine to elicit selective antibodies for toxic amyloid-beta oligomers (AβO) without inducing a potentially detrimental immune response to normal forms of Aβ.
March 16, 2022 - Biogen Inc. announced new data showing that after nearly two and a half years of treatment (128 weeks) with ADUHELM® injection 100 mg/mL for intravenous use, patients in the long-term extension phase of the Phase 3 trials continued to experience significant reductions in two key Alzheimer's disease pathologies, amyloid-beta plaques, and plasma p-tau181. The data also show that in both Phase 3 trials, at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced.
March 16, 2022 - Prothena Corporation plc presented new preclinical data from its dual Aβ/tau vaccine for the potential treatment and prevention of AD and its tandem C-terminal α-synuclein vaccine programs for the potential treatment and prevention of Parkinson's disease and related synucleinopathies. Prothena's dual Aβ/tau vaccines were described as linear peptide conjugates designed to prevent the two key processes associated with AD: 1) the formation of Aβ-plaque and 2) the development of intraneuronal tau tangles.
March 15, 2022 - Araclon Biotech advances in its innovative vaccine and diagnostic test for Alzheimer's. Presented ABvac40 and ABtest-MS study results at the AD/PD™ 2022 Conference in Barcelona.
March 14, 2022 - A $289 million increase for Alzheimer's and dementia research funding at the U.S NIH was signed into law. Added to current NIH spending, the federal government's annual Alzheimer's and dementia research funding is up to $3.5 billion.
February 4, 2022 - AC Immune SA announced that preclinical data on the optimized formulation of its amyloid-beta (Abeta) vaccine program, ACI-24, were published in the peer-reviewed journal Brain Communications. AC Immune plans to advance the clinical development of the optimized formulation to the next stage for both Alzheimer's disease and Down syndrome-related AD in 2022.
November 16, 2022 - Brigham and Women's Hospital is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow AD progression. The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. Protollin is composed of bacteria-derived proteins and has been used safely in humans as an adjuvant for other vaccines.
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