AV-1959D / Capo Therap, Nuravax - LARVOL DELTA

Study of AV-1959D, an Amyloid Beta Vaccine (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Institute for Molecular Medicine | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

mRNA Vaccine for Alzheimer's Disease: Pilot Study. (PubMed, Vaccines (Basel)) - "FDA-approved lecanemab significantly reduces Aβ aggregates from the brains of early AD patients administered biweekly with this humanized monoclonal antibody. Our current pilot study combined our advanced MultiTEP technology with a novel mRNA approach to develop an mRNA vaccine encapsulated in lipid-based nanoparticles (LNPs), AV-1959LR. Here, we report our initial findings on the immunogenicity of 1959LR in mice and non-human primates, comparing it with the immunogenicity of its DNA counterpart, AV-1959D."

Journal • Alzheimer's Disease • CNS Disorders

Study of AV-1959, an Amyloid Beta Vaccine (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Institute for Molecular Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Study of AV-1959, an Amyloid Beta Vaccine (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Institute for Molecular Medicine | Trial completion date: Apr 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Phase 1 Study of AV-1959, an Amyloid Beta Vaccine for Alzheimer's Disease (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Institute for Molecular Medicine

New P1 trial • Alzheimer's Disease • CNS Disorders

Institute for Molecular Medicine Receives $12 Million NIH Grant to Fund Clinical Trials of AV-1959, First Preventive Vaccine for Alzheimer's Disease (PRNewswire) - "The Institute for Molecular Medicine...announced that it was awarded a $12 million grant from the National Institute on Aging (NIA) division of the U.S. National Institutes of Health (NIH) to support clinical trials of its beta-amyloid (Aβ) vaccines based on DNA (AV-1959D) and recombinant protein (AV-1959R) for the prevention of Alzheimer's disease (AD). In collaboration with the University of California, Irvine (Principal Investigator, David Sultzer, M.D.) and University of Southern California (Principal Investigator, Lon Schneider, M.D.), IMM (Principal Investigator and NIH contact, Michael Agadjanyan, Ph.D.) expects to begin a Phase 1 clinical study in the U.S. in the second quarter of 2022."

Financing • Alzheimer's Disease • CNS Disorders

Characterization and preclinical evaluation of the cGMP grade DNA based vaccine, AV-1959D to enter the first-in-human clinical trials. (PubMed, Neurobiol Dis) - "Multiple immunizations of Tg-SwDI mice with AV-1959D did not induce T and B cell infiltration, glial activation, vascular deposition of Aβ, or neuronal degeneration (necrosis and apoptosis) greater than that in the control group determined by immunohistochemistry of brain tissues. Taken together, the safety data from two different mouse models of AD substantiate a favorable safety profile of the cGMP grade AV-1959D vaccine supporting its progression to first-in-human clinical trials."

Journal • P1 data • Review • MRI