Alzheimer's Disease Vaccines May 2023
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. Unfortunately, the U.S. Food and Drug Administration (FDA) had not authorized preventive Alzheimer's disease vaccines as of May 2023.
Alzheimer's Vaccine Candidates 2023
Sponsored clinical studies are developing Alzheimer's disease vaccines and treatments, seeking study participants in the U.S. and Europe.
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 inhibit plaque formation and increase plaque clearance efficiently 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.
Alzamend Neuro, Inc.'s Phase 2A Multiple Ascending Dose Clinical Trial for ALZ002 itreatingof dementia-related to Alzheimer's. On March 22, 2023, it announced the completion of the clinical portion of its Phase IIA multiple ascending dose study. On April 3, 2023, a phase I/IIA clinical trial was initiated for ALZN002.
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 U.S. FDA approvafor treating AD l on January 6, 20AD. The approval of Leqembi (BAN2401, lecanemab-irmb) was granted to Eisai R&D Management Co., Ltd. On June 9, 2023, an FDA committee will discuss supplemental biologics license application 761269/s-00 for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., fortreatingf early AD.
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.
Eli Lilly and Company presented Interim Analysis from a Phase 1 Study of LY3372993 on March 31, 2023. Remternetug (LY3372993) is an IgG1 monoclonal antibody directed at the pyroglutamate modification of the third amino acid of amyloid-beta peptide that is present only in brain amyloid plaques. That demonstrated rapid and robust amyloid plaque reduction in participants with AD. The safety, tolerability, and pharmacokinetic/pharmacodynamic data support the ongoing phase 3 trial (NCT05463731).
ADvantage Therapeutics, Inc. announced that the UK's MHRA had granted AD04™ an Innovation Passport for treating AD under the Innovative Licensing and Access Pathway on April 5, 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.
BCG Vaccination and Dementia
An Original Investigation led by investigators at Massachusetts General Hospital and Brigham and Women’s Hospital was published by The JAMA Network on May 19, 2023, concluding that BCG vaccination was associated with a lower rate and risk of Alzheimer's disease and related dementia. In competing risks analysis, the BCG vaccine was associated with a lower risk of Alzheimer's disease and related dementias (ADRD) (5-year risk difference, −0.011; 95% CI, −0.019 to −0.003) and a decreased risk of death in patients without an earlier diagnosis of ADRD (5-year risk difference, −0.056; 95% CI, −0.075 to −0.037).
Alzheimer's Testing
Researchers at Karolinska Institutet announced on April 12, 2023, that a type of sugar molecule in the blood is associated with the level of Tau. This protein plays a critical role in the development of severe dementia. Therefore, Bisecting N-acetylglucosamine and Tau is a valuable blood biomarker for predicting AD.
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 assessed 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 2023
Clinical trials are listed on this sponsored website.
Alzheimer's Vaccine News 2023
April 21, 2023 - “The idea that common infections could contribute to cognitive decline and perhaps Alzheimer’s disease risk was once on the fringe and remains controversial, but due to findings like the ones from this study, it’s starting to get more mainstream attention,” says senior author Adam Spira, Ph.D., professor in the Bloomberg School’s Department of Mental Health
April 5, 2023 - Jeffrey Madden, CEO of ADvantage, stated, "AD04™ may completely change the approach to the treatment of Alzheimer's Disease."
April 3, 2023 - Stephan Jackman, CEO of Alzamend, stated in a press release, "Intermittent use of our immunotherapeutic vaccine (ALZN002) may be expected to limit the number of infusions needed, may reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans afflicted with this devastating disease."
February 21, 2023 - The JAMA Network published an Original Investigation analysis that included 31 929 participants of African ancestry; stratified analyses demonstrated that the APOE ε3[R145C] missense variant was associated with an increased risk of AD among individuals with the ε3/ε4 genotype in a discovery cohort (odds ratio, 3.01), a replication cohort (odds ratio, 2.20), and an external validation cohort (odds ratio, 1.90)Withth, additional external validation these findings, may inform AD genetic risk assessment in individuals of African ancestry.
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 the ACI-24.060 vaccination has been safe and well tolerated. 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 most significant effect association was between viral encephalitis exposure and Alzheimer's disease. In addition, intestinal infections and varicella-zoster virus were significant and replicated for more than one NDD.
January 19, 2023 - Scientific American published: An Old TB Vaccine Might Help Stave Off Diabetes, Cancer, Alzheimer's, and More.
January 6, 2023 - The U.S. FDA approved Leqembi (lecanemab-irmb) indicated for AD. The labeling states that treatment with Leqembi should be cited in patients with mild cognitive impairment or mild dementia stage of the disease. In addition, the labeling assays that there are no safety or effectiveness data starting treatment at earlier or later stages of the disease than were studied.
January 5, 2023 - The NEJM published an Original Article - Lecanemab in Early Alzheimer's Disease. Lecanemab reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline in measures of cognition and function than placebo at 18 months but was associated with adverse events.
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 20, 2022 - A research article published by Advanced Materials found a versatile SNC nanoplatform may offer a novel strategy for fotreatingof CNS disorders, including Alzheimer's.
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 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 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 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.
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. 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 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 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 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 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.
June 27, 2020 - People who received at least one flu vaccination were 17% less likely to get Alzheimer's disease throughout a lifetime, according to researchers at The University of Texas Health Science Center at Houston.
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