AADvac1 / Axon Neurosci - LARVOL DELTA

Active Vaccination Strategies for Alzheimer's Disease: An Expanded Review. (PubMed, Eur J Immunol) - "Early vaccines such as AN1792 demonstrated proof-of-concept but were limited by T-cell-mediated adverse events. Second-generation approaches, including CAD106, UB-311, ABvac40 and ACI-24, improved safety and immunogenicity through short peptide fragments and liposomal formulations...Tau-targeted vaccines, including AADvac1, ACI-35 and AV-1980R, show selective reduction of pathological Tau with promising preclinical and early clinical results. Combined Aβ/Tau vaccination demonstrates synergistic effects in preclinical models, supporting multi-target strategies. Future directions focus on preventive vaccination, alternative delivery routes and biomarker-driven personalisation, collectively supporting a shift towards integrated multi-target immunotherapy capable of modulating AD pathology and potentially altering its long-term clinical course."

IO biomarker • Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation

The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1 (clinicaltrials.gov) - P2 | N=146 | Enrolling by invitation | Sponsor: Adam Boxer | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • CNS Disorders • Movement Disorders • Progressive Supranuclear Palsy

CurePSP Announces Enrollment of First Participant in the PSP Trial Platform (Yahoo Finance) - "Led by the University of California, San Francisco (UCSF) and funded by a five-year grant of up to $75.4 million from the National Institute on Aging (NIA), the PTP is being conducted at 50 sites nationwide...The trial aims to enroll 440 participants over 2 years. Unlike traditional clinical trials, the PTP is designed so that 75% of participants receive an active drug during the first year, reducing the number of patients assigned to placebo. After that, all participants receive an active drug...Two of the drugs being tested are LM11A-31, from PharmatrophiX, and AADvac1, from Axon Neuroscience."

Enrollment open • CNS Disorders • Progressive Supranuclear Palsy

PTP: The Progressive Supranuclear Palsy Clinical Trial Platform (clinicaltrials.gov) - P2 | N=440 | Recruiting | Sponsor: Adam Boxer | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Progressive Supranuclear Palsy

ATP: Alzheimer's Tau Platform: Regimen A - AADvac1 (clinicaltrials.gov) - P2 | N=450 | Enrolling by invitation | Sponsor: Paul S. Aisen | Not yet recruiting ➔ Enrolling by invitation | Initiation date: Jun 2026 ➔ Nov 2026

Enrollment open • Trial initiation date • Alzheimer's Disease • CNS Disorders

ATP: Alzheimer's Tau Platform: Master Protocol (clinicaltrials.gov) - P2 | N=900 | Recruiting | Sponsor: Paul S. Aisen | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • APOE

Immunotherapeutic Advances in Alzheimer's Disease: The Convergence of Vaccinology and Nanoscience. (PubMed, Curr Alzheimer Res) - "This study was performed using MeSH term search by using keywords, like "Alzheimer's Disease", "AD", "Vaccines", "Nanoformulations", "Amyloid-Beta (Aβ) Vaccines", "lecanemab", "Tau protein Vaccines", "AADvac1", "Clinical trials". Current developments, including the incorporation of short Aβ epitopes, liposomal formulations, conformational mimotopes, and virus-- like particles (VLPs), have markedly enhanced vaccine tolerability. Effective AD treatments depend on combination medications, individualized approaches, and ongoing research into crossing the BBB and improving the safety and effectiveness of vaccines."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Gene Therapies

PTP: The Progressive Supranuclear Palsy Clinical Trial Platform (clinicaltrials.gov) - P2 | N=440 | Not yet recruiting | Sponsor: Adam Boxer | Trial completion date: Jul 2029 ➔ Sep 2030 | Initiation date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jul 2029 ➔ Sep 2030

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Movement Disorders • Progressive Supranuclear Palsy

The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1 (clinicaltrials.gov) - P2 | N=146 | Not yet recruiting | Sponsor: Adam Boxer | Trial completion date: Jul 2029 ➔ Sep 2030 | Initiation date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jul 2029 ➔ Sep 2030

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Movement Disorders • Progressive Supranuclear Palsy

ATP: Alzheimer's Tau Platform: Master Protocol (clinicaltrials.gov) - P2 | N=750 | Not yet recruiting | Sponsor: Paul S. Aisen | Initiation date: Nov 2025 ➔ Jun 2026

Trial initiation date • Alzheimer's Disease • CNS Disorders • APOE

ATP: Alzheimer's Tau Platform: Regimen A - AADvac1 (clinicaltrials.gov) - P2 | N=375 | Not yet recruiting | Sponsor: Paul S. Aisen | Initiation date: Nov 2025 ➔ Jun 2026

Trial initiation date • Alzheimer's Disease • CNS Disorders

The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1 (clinicaltrials.gov) - P2 | N=146 | Not yet recruiting | Sponsor: Adam Boxer

New P2 trial • CNS Disorders • Movement Disorders • Progressive Supranuclear Palsy

PTP: The Progressive Supranuclear Palsy Clinical Trial Platform (clinicaltrials.gov) - P2 | N=440 | Not yet recruiting | Sponsor: Adam Boxer

New P2 trial • CNS Disorders • Movement Disorders • Progressive Supranuclear Palsy

ATP: Alzheimer's Tau Platform: Regimen A - AADvac1 (clinicaltrials.gov) - P2 | N=375 | Not yet recruiting | Sponsor: Paul S. Aisen

New P2 trial • Alzheimer's Disease • CNS Disorders

Efficacy, Immunogenicity, Safety, and Tolerability of AADvac1 in Alzheimer Disease: A Systematic Review and Meta-Analysis of Placebo-Controlled Trials. (PubMed, Alzheimer Dis Assoc Disord) - "AADvac1 demonstrates robust immunogenicity and an acceptable safety profile in early-phase trials. Cognitive benefits remain inconclusive. Larger, long-term trials are needed to confirm its clinical efficacy and long-term safety in AD."

IO biomarker • Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Infectious Disease

Progressive Supranuclear Palsy Phase 2 Platform Clinical Trial Announces the Selection of AADvac1 and AZP2006 for its First Two Regimens (ACCESSWIRE) - "The Progressive Supranuclear Palsy (PSP) Trial Platform (PTP)...has selected two promising drug candidates-Axon Neuroscience's AADvac1 and Alzprotect's AZP2006-for inclusion in the platform trial as the first two compounds to be evaluated. The trial aims to accelerate the development of effective treatments for PSP, a rare and fatal neurodegenerative disease. Additional compounds to be evaluated in the trial are expected to be announced later this year. Funded by the National Institute on Aging (NIA), part of the U.S. National Institutes of Health (NIH), the platform trial is supported by a five-year grant. Its design enables multiple therapies to be tested concurrently, establishing a perpetual, efficient and flexible path to evaluate promising drug candidates."

Clinical • Progressive Supranuclear Palsy

Post hoc analysis of ADAMANT, a phase 2 clinical trial of active tau immunotherapy with AADvac1 in patients with Alzheimer's disease, positive for plasma p-tau217. (PubMed, Alzheimers Res Ther) - P2 | "These results suggest that AADvac1 tau immunotherapy can reduce plasma biomarkers of neurodegeneration and neuroinflammation. These findings and possible observations on brain atrophy and cognition are hypothesis-generating and warrant further evaluation in a larger clinical trial."

Biomarker • Clinical • IO biomarker • Journal • P2 data • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation • GFAP • Plasma NfL

Efficacy assessment of an active tau immunotherapy in Alzheimer's disease patients with amyloid and tau pathology: a post hoc analysis of the "ADAMANT" randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial. (PubMed, EBioMedicine) - P2 | "In the subgroup of ML imputed or CSF identified A+T+, AADvac1 slowed AD-related decline in an antibody-dependent manner. Larger anti-tau trials are warranted."

Journal • P2 data • Retrospective data • Alzheimer's Disease • CNS Disorders

Tau vaccine AADvac1 demonstrates clinical and biomarker efficacy on patients with plasma p-tau217 defined Alzheimer's disease in Phase II clinical trial: post hoc analysis (CTAD 2023) - P2 | "Tau-targeted active immunotherapy with AADvac1 showed significant treatment effects in biomarker-confirmed AD patients on cognitive and neurodegeneration-related biomarker endpoints. The response to treatment was directly related to the levels of AADvac1-induced anti-tau antibodies. These findings support a Phase IIb clinical trial on A+T+ biomarker-confirmed patients with early AD."

Biomarker • Clinical • IO biomarker • Late-breaking abstract • P2 data • Retrospective data • Alzheimer's Disease • CNS Disorders • Aβ42 • NEFL • Plasma NfL • p-tau181

"When will be release aadvac1 phase 3 results?" (,@totaIcristano)

P3 data

AXON Neuroscience Presented Results from its Phase II Clinical Trial Showing Multifold Therapeutic Effect of its Vaccine-Induced Antibodies at Eurotau2021 (Yahoo Finance) - “AXON presented results from its Phase II Clinical Study for AADvac1, vaccine against Alzheimer's presented at Eurotau2021. AXON demonstrated that vaccination-induced antibodies can stop the interaction and spreading of pathological tau species and protect the brain from tau toxicity….AXON NEUROSCIENCE SE…presented results from its Phase II clinical study of its tau vaccine AADvac1 against Alzheimer's disease at the Eurotau2021 Meeting, which was being held in Lille, France on October 25-26, 2021.”

P2 data • Alzheimer's Disease • CNS Disorders

The mechanism of action and efficacy of AADvac1, an active immunotherapy against pathological tau protein, in a placebo-controlled randomised phase 2 study (AAIC 2021) - "These findings suggest that AADvac1 offers an efficacious approach to the treatment of neurofibrillary degeneration in AD with well-defined mechanism of action."

Clinical • IO biomarker • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • MRI • Plasma NfL

Nature Aging publishes phase II results for AADvac1, a first-in-man Alzheimer's tau vaccine developed by Axon Neuroscience (PRNewswire) - P2, N=208; ADAMANT (NCT02579252); Sponsor: Axon Neuroscience SE; "AADvac1 demonstrates robust antibody response, excellent safety profile and highly significant impact on neurodegeneration...Evidence of clear therapeutic effect on blood neurofilament light chain protein in the whole study sample...In patients with confirmed Alzheimer's disease biomarker profile (amyloid and tau positivity) AADvac1 shows a strong efficacy signal, demonstrated by significant slowing of clinical and functional decline as measured by CDR-SB and ADCS-MCI-ADL..."

P2 data • Alzheimer's Disease • CNS Disorders

[VIRTUAL] AXON Neuroscience (BIO 2021) - "AXON Neuroscience is world’s most clinically advanced biotech in the field of Alzheimer’s disease tau therapeutics with first-in-man tau vaccine AADvac1. The company has successfully completed the preclinical phase for its lead COVID-19 asset: ACmab1 (therapeutic antibodies against COVID-19). This confirmed superior characteristics of ACmab1 vs. other therapies, in terms of efficacy on new mutated variants, method of administration, as well as its significantly lower pricing potential."

Alzheimer's Disease • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Alzheimer's disease: Recent treatment strategies. (PubMed, Eur J Pharmacol) - "Current treatment for AD (donepezil, galantamine, rivastigmine and memantine) is only symptomatic and has modest benefits...Even the positive findings presented by Biogen on Aducanumab are not entirely clear and further data is necessary to confirm its validity...Four monoclonal antibodies anti-tau (Gosuranemab, Tilavonemab, Semorinemab and Zagotenemab) and one anti-tau vaccine (AADvac1) have reached phase II, so far. In this review, we discuss the potential disease-modifying agents tested in clinical trials and update the information of drugs that are still under clinical evaluation."

Journal • Review • Alzheimer's Disease • CNS Disorders