AV-1980R / Capo Therap, Nuravax - 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

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Institute for Molecular Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Institute for Molecular Medicine | Initiation date: Dec 2025 ➔ Aug 2026

First-in-human • IO biomarker • Trial initiation date • Alzheimer's Disease • CNS Disorders

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Institute for Molecular Medicine

IO biomarker • New P1 trial • Alzheimer's Disease • CNS Disorders

First-in-human AV-1980R/A tau vaccine for Alzheimer's prevention (IND 29644) (CTAD 2024) - No abstract available

P1 data • Alzheimer's Disease • CNS Disorders

PHASE 1 PREVENTIVE ADJUVANTED TAU VACCINE, AV-1980R (ADPD 2023) - "For example, treatment with the anti-amyloid fibril mAb lecanemab reduced attenuates cognitive decline; and these mAbs in general decrease plasma, CSF, and brain p-tau and tau. Conclusions Immunogenically active, safe, and effective vaccines are ideal candidates for preventative therapy in cognitively unimpaired people for inhibiting accumulation of tau pathology and potentially delaying illness onset. We are evaluating for the first-time a preventive vaccine, AV-1980R/A targeting the phosphatase-activating domain ( PAD) of pathological tau."

Clinical • IO biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Hematological Disorders • Aβ42 • GFAP • NEFL • p-tau181

IMMUNOGENICITY OF MULTITEP PLATFORM TECHNOLOGY-BASED TAU VACCINE IN NON-HUMAN PRIMATES: PRELUDE TO CLINICAL TRIALS (ADPD 2023) - "Lon Schneider's presentation). We hypothesize that vaccination of cognitively unimpaired people at risk of AD with AV-1980R/A can produce antibodies that will bind PAD of extracellular Tau and reduce the propagation of this early pathological molecule in the brain, thus delaying the onset of dementia."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia • CRP

Phase 1 Preventive Adjuvanted Tau Vaccine, AV-1980R (CTAD 2022) - "A recent report stated that treatment with anti-amyloid mAb lecanemab reduced cognitive decline by 0.45 CDR-SB points. Passive mAb immunotherapy for cognitively unimpaired people is impractical due to the complexity and need for frequent administration of very high doses. Safe and immunogenic active vaccines are suitable candidates for preventing the accumulation of tau pathology and potentially delaying onset of illness. We are evaluating for the first-time preventive vaccine, AV-1980R/A targeting the phosphatase-activating domain (PAD) of pathological tau."

Clinical • IO biomarker • Late-breaking abstract • P1 data • Alzheimer's Disease • CNS Disorders • Hematological Disorders • GFAP • NEFL • Plasma Aβ42

A novel dementia vaccine targeting three B cell epitopes of Pathological α-Synuclein (PRNewswire) - "A potential preventive vaccine against Dementia Lew Body and Parkinson's disease moves from the mouse model of Synucleinopathies to the IND enabling studies....The most effective nucleic acid vaccine, PV-1950D, generated antibodies specific to three regions of α-Synuclein simultaneously, reduced the aggregation of this pathological molecule, and improved motor deficits in the mouse model of disease. In a new study...two co-first-author scientists from IMM, Karen Zagorsky, Ph.D., and Gor Chailyan, Ph.D., along with the team of collaborators from IMM, UCI, and the Laboratory of Neurogenetics, NIA, report on the development of the same vaccine in the form of the recombinant protein, PV-1950R, formulated in adjuvant."

Preclinical • CNS Disorders • Parkinson's Disease

Gates Biomanufacturing Facility Announces Manufacture of Recombinant Protein - Alzheimer's Disease Vaccine for Institute for Molecular Medicine's Clinical Trials (PRNewswire) - “The Gates Biomanufacturing Facility (GBF) has announced the successful completion of the full cycle manufacturing of the recombinant Bulk Drug Substance (BDS) of the anti-Tau vaccine, AV-1980R, in collaboration with the Institute for Molecular Medicine (IMM), California….As a result of this work, AV-1980R Drug Substance can be used for phase 1 and phase 2 clinical trials in humans. This work was financed through funding provided by the U.S. National Institute on Aging (NIA)….AV-1980R vaccine targets Alzheimer's Disease (AD) and other Tau aggregation-associated neurodegenerative conditions by providing outstanding levels of antibody protection against harmful forms of Tau protein that may lead to disease.”

Commercial • Financing • Alzheimer's Disease • CNS Disorders

Immunogenicity of MultiTEP platform technology-based Tau vaccine in non-human primates. (PubMed, NPJ Vaccines) - "The resulting anti-PAD IgG antibodies recognize pathological Tau tangles and Tau-positive neuritis in AD case brain sections with no staining in control non-AD cases. These published data and efficacy results support the AV-1980R/A vaccine progression to first-in-human clinical trials."

Journal • Alzheimer's Disease • CNS Disorders

A MultiTEP platform-based epitope vaccine targeting the phosphatase activating domain (PAD) of tau: therapeutic efficacy in PS19 mice. (PubMed, Sci Rep) - "Importantly, vaccination also prevented age-related motor and cognitive deficits in PS19 mice and significantly reduced insoluble total and phosphorylated tau species. Taken together, these findings suggest that predominantly targeting misfolded tau with AV-1980R/A could represent an effective strategy for AD immunotherapy."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders