Alzheimer's Disease Vaccines 2022
According to the Alzheimer's Association, Alzheimer's disease (AD) is a degenerative brain disease caused by complex brain changes following cell damage, leading to dementia symptoms that gradually worsen.
However, the U.S. Food and Drug Administration (FDA) had not authorized preventive Alzheimer's disease vaccines as of January 26, 2023.
Alzheimer's Disease and Influenza Vaccination
A study from UTHealth Houston, announced on June 24, 2022, found that people who received at least one influenza vaccination were 40% less likely to develop AD over four years. A separate study published on August 2, 2022, supported that finding: The RR was 0.60 (95% CI, 0.59–0.61), and ARR was 0.034 (95% CI, 0.033–0.035), corresponding to a number needed to treat of 29.4.
Alzheimer's Vaccine Candidates 2023
Sponsored clinical studies in the U.S. and Europe are developing Alzheimer's disease vaccines and seeking study participants.
AADvac1 is a therapeutic vaccine candidate for Alzheimer's disease that targets misfolded tau protein, a common denominator of neurofibrillary pathology.
ACI-24.060 is an amyloid-beta (Abeta) antibody produced 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, in the ACI-24 program in Phase 1 and 2 trials. This investigational candidate has the potential to efficiently inhibit plaque formation and increase plaque clearance and thereby may reduce or prevent disease progression.
ACI-35.030 is a first-in-class AD vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. AC Immune is collaborating with Janssen Pharmaceuticals, Inc. Recent results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, ePHF. In addition, the ACI-35.030-induced antibody response was sustained and could be periodically boosted over 72 weeks.
Alzinova AB's ALZ101 is an active, therapeutic oligomer-specific vaccine candidate that stimulates the production of antibodies against the toxic Aβ oligomers. The first-in-human phase 1b study in patients with early AD was initiated in 2021. Alzamend is also pursuing AL001 for the treatment of bipolar disorder and PTSD. Topline data for the analysis is anticipated in the second half of 2023. In addition, the Company partnered with the Miller School of Medicine and the Interdisciplinary Stem Cell Institute at the University of Miami in Florida for its Phase I/IIA clinical trial of ALZN002.
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. As a result, it was granted U.S. FDA Fast Track status.
Alzheimer's Treatments 2023
Aduhelm™ is an amyloid beta-directed antibody injection of 100 mg/mL for intravenous use indicated to treat AD and was approved by the FDA on July 8, 2021. The FDA issued approval to Biogen and Eisai Co., Ltd.
Leqembi™ gained FDA approval on January 6, 2023, via the Accelerated Approval pathway for AD. The approval of Leqembi (BAN2401, lecanemab-irmb) was granted to Eisai R&D Management Co., Ltd. The FDA granted this application Fast Track, Priority Review, and Breakthrough Therapy designations. "This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."
Alzheimer's Treatment Candidates 2023
Eli Lilly and Company announced on January 19, 2023, the U.S. FDA had issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted. The confirmatory Phase 3 TRAILBLAZER-ALZ 2 clinical trial is ongoing, with topline data read-out expected in 2023.
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. ALZN002 immunotherapy is intended to treat patients diagnosed with Alzheimer's by inducing the patient's antibodies. These are targeted to remove the Aβ1‑42 protein, reducing the deposition of amyloid plaque in the brain and thereby reducing the progression of disease-associated clinical signs and symptoms. The Company partnered with Biorasi as its contract research organization.
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. Accordingly, the U.S. FDA granted Fast Track Designation on April 26, 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 AD and other causes of cognitive decline.
On December 27, 2022, a new study: Brain-derived tau: a novel blood-based biomarker for Alzheimer's disease-type neurodegeneration, presented a novel blood test that assesses brain-derived tau detected Alzheimer's-related neurodegeneration and differentiated Alzheimer's from other neurodegenerative diseases. Furthermore, this innovative test outperformed total tau and, unlike neurofilament light, showed specificity to Alzheimer's disease-type neurodegeneration. Thus, brain-derived tau demonstrates the potential to complete the AT(N) scheme in blood and will be used in evaluating Alzheimer's disease-dependent neurodegenerative processes for clinical and research purposes.
Alzheimer's Vaccine Clinical Trials
Clinical trials are listed on this sponsored website.
Alzheimer's Vaccine News 2022
January 26, 2023 - AC Immune posted early results from the first cohort of AD patients in the ABATE study showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection). The data show that ACI-24.060 vaccination has been safe and well tolerated to date. As a result, dosing in ABATE's second, higher-dose AD cohort has begun, and the trial is cleared to start screening individuals with DS for part 2 of the study.
January 19, 2023 - Neuron published research - Virus exposure and neurodegenerative disease risk across national biobanks. Using time series data from FinnGen for discovery and cross-sectional data from the UK Biobank for replication, they identified 45 viral exposures significantly associated with increased risk of neurodegenerative disease and replicated 22 of these associations. The largest effect association was between viral encephalitis exposure and Alzheimer’s disease. Intestinal infections and varicella-zoster virus were also significant and replicated for more than one NDD.
January 6, 2023 - The U.S. FDA approved Leqembi (lecanemab-irmb). The prescribing information says Leqembi is indicated for AD. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease. The labeling assays that there are no safety or effectiveness data starting treatment at earlier or later stages of the disease than were studied.
December 26, 2022 - In an article published in the journal Proceedings of the National Academy of Sciences, Kraemer, and his UW Graduate Program in Neuroscience, reported the identification of a protein that appears to be crucial in forming abnormal collections of tau. The scientists showed that blocking the gene required for protein production makes it possible to prevent the accumulation of tau in an animal model. The protein is called speckle-type POZ protein (SPOP).
December 2, 2022 - Researchers presented the results in a Late Breaking poster entitled, "Effects of the p38α kinase inhibitor neflamapimod on the basal forebrain, assessed by structural MRI, in Alzheimer's disease. The significant finding in the analysis was that 12 weeks of neflamapimod treatment in phase 2a clinical trial in 14 patients with early AD was associated with a significant (p=0.03, median 4.5%) increase in the volume of the Nucleus Basalis of Meynert, the major cholinergic nucleus in the basal forebrain.
November 30, 2022 - AC Immune announced data presented at CTAD 2022 confirmed an excellent clinical performance of the ACI-35.030 vaccine candidate. Based on this new clinical data, ACI-35.030 has been selected for further development representing significant progress for the anti-pTau vaccine candidate.
November 29, 2022 - Eisai Co., Ltd., and Biogen Inc. announced that the results from the Phase 3 confirmatory Clarity AD clinical study of lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to AD with confirmed presence of amyloid pathology in the brain. The study found reduced amyloid markers in early AD but was associated with adverse events.
November 28, 2022 - A recent dementia vaccine study published in the International Journal of Molecular Sciences reported developing a vaccine in the form of the recombinant protein, PV-1950R, formulated in adjuvant.
November 27, 2022 - A recent clinical trial death, described in an unpublished case report, Science obtained, is the second thought associated with Biogen Inc.'s antibody lecanemab.
November 21, 2022 - EmbarkNeuro announced that the first patient had been dosed in its Phase 2 trial of ANC-501, a first-in-class vasopressin 1b (V1b) receptor antagonist for the treatment of the major depressive disorder. This 8-week single-arm trial will assess the efficacy of ANC-501 when added to standard antidepressant therapy in patients with biomarker-confirmed disruption in their stress-response system.
November 17, 2022 - Published in the journal Nature, the protein medin is deposited in the blood vessels of the brains of Alzheimer's patients along with the protein amyloid-β, according to researchers from DZNE.
October 31, 2022 - Alzamend Neuro announced receipt of a "Study May Proceed" letter from the U.S. FDA for a phase I/IIA clinical trial under its IND application for ALZN002.
October 5, 2022 - Alzamend Neuro, Inc. announced it dosed its first healthy adult in its Phase IIA multiple ascending dose study of AL001 in subjects with dementia related to Alzheimer's.
September 27, 2022 - Biogen and Eisai's investigational Alzheimer's disease treatment slowed the rate of cognitive decline by 27% in a clinical trial.
September 13, 2022 - IOS Press published: Association of COVID-19 with New-Onset Alzheimer's Disease. 'We show that people with COVID-19 were at significantly increased risk for a new diagnosis of Alzheimer's disease within 360 days after the initial COVID-19 diagnosis (hazard ratio or HR:1.69, 95% CI: 1.53–1.72), especially in people aged≥85 years and in women.'
September 7, 2022 - Alzinova AB announced a second external safety review had been carried out of the Company's phase 1b clinical study of ALZ-101, with a positive assessment to continue the study as planned. The ALZ-101 study for early Alzheimer's disease is a placebo-controlled, double-blind, randomized First In Human clinical trial.
August 2, 2022 - Researchers at Tufts University and The University of Oxford demonstrated the presence of two viruses that can promote excess proteins responsible for Alzheimer's characteristic brain plaques. Conclusion: Our results are consistent with the suggestion that shingles cause reactivation of HSV1 in the brain and with the protective effects against AD of various vaccines, as well as the decrease in herpes labialis reported after certain types of vaccination.
August 1, 2022 - Vaxxinity, Inc. presented new preclinical data on vaccine candidates targeting aberrant forms of the Tau protein for Alzheimer's disease. The poster "Characterization of Tau vaccines identifies diverse antibody binding and efficacy profiles." "Our findings show that vaccines can target specific forms of Tau with subsequent functional impact," said Justin Boyd, Ph.D., Director of Translational Science at Vaxxinity.
July 20, 2022 - Blue Water Vaccines Inc. announced a Sponsored Research Agreement with Cincinnati Children's Hospital Medical Center to explore vaccine development for multiple diseases. Ming Tan, Ph.D., associate professor in the Division of Infectious Diseases, is the principal investigator for the research at Cincinnati Children's.
July 18, 2022 - Alzamend Neuro, Inc. announced that it had received a written response to its meeting request relating to its Type B Pre-Investigational New Drug Application from the U.S. FDA that provides a path for the planned clinical development of AL001 for the treatment of the bipolar disorder, MDD, and PTSD.
July 5, 2022 - Alzinova AB announced it successfully verified that the manufacturing process for vaccine doses of ALZ-101, the Company's vaccine candidate against Alzheimer's disease, can be scaled up to deliver larger production volumes required for clinical phase 2 trials.
July 4, 2022 - Research published in the Journal of Alzheimer's Disease suggests that a multimodal approach to Alzheimer's and dementia prevention may slow and even reversprogressiveed cognitive decline.
June 30, 2022 - The Alzheimer's Association published - Genome-wide association and multi-omics studies identify MGMT as a novel risk gene for Alzheimer's disease (AD) among women. To identify novel genes associated with tau-related pathology, we conducted two genome-wide association studies for AD, one among 10,340 ε4– women in the Alzheimer's Disease Genetics Consortium and another in 31 members (22 women, a consanguineous Hutterite kindred. The findings suggest that epigenetically regulated MGMT expression is involved in AD pathogenesis, especially in women.
June 13, 2022 - People who received at least one influenza vaccine were 40% less likely than their non-vaccinated peers to develop Alzheimer's disease over four years, according to a new study from UTHealth Houston.
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 the U.S. FDA granted UB-311 Fast Track Designation 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.
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. Furthermore, 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 13, 2022 - Results from a significant study highlight the need to continuously monitor breakthrough SARS-CoV-2 infections and outcomes in vaccinated patients with dementia.
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 to 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. In addition, 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 complete 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. In addition, 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 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 possible 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 critical 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. As a result, AC Immunplannedns 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 to test the safety and efficacy of a nasally new vaccine delivered 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.
June 27, 2020 - People who received at least one flu vaccination were 17% less likely to get Alzheimer's diseasthroughoutof a lifetime, according to researchers at The University of Texas Health Science Center at Houston.
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. 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.
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