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

Nuravax, Institute for Molecular Medicine to Present Phase 1 Results and Phase 2 Design of Alzheimer's Vaccine AV-1959R at CTAD 2025 (PRNewswire) - "Nuravax...announced today that two oral presentations-the Phase 1 clinical results and the Phase 2 secondary prevention study design for its licensed lead Drug Product, the amyloid-beta (Aβ) vaccine, AV-1959R-have been accepted at the 18th Clinical Trials on Alzheimer's Disease (CTAD-25) conference, scheduled for December 3–5 in San Diego, California....Two oral presentations to highlight the safety, immunogenicity, and future development of AV-1959R for primary and secondary prevention of Alzheimer's disease."

Clinical protocol • P1 data • Alzheimer's Disease

Nuravax Alzheimer’s Vaccine to Amyloid-Beta Is Safe, Immunogenic in Phase 1 (Inside Precision Medicine) - P1 | N=16 | NCT06831812 | Sponsor: Nuravax, Inc. | "...Nuravax’s Alzheimer’s disease mRNA vaccine AV-1959R for amyloid beta recently passed its first clinical milestone: the vaccine was deemed safe and triggered strong immune responses in all participants during Phase I trials. No serious adverse events (SAEs) have been reported from the vaccine thus far, and MRI scans have revealed no indications of ARIA-E (edema) or ARIA-H (microhemorrhages) in both the vaccinated and placebo groups, indicating that the vaccine is safe."

P1 data • Alzheimer's Disease

Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Nuravax, Inc. | Trial completion date: May 2025 ➔ Oct 2025 | Trial primary completion date: Mar 2025 ➔ Oct 2025

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

Phase I Study of AV-1959R: Safety, Tolerability, and Immunogenicity in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Nuravax, Inc.

New P1 trial • Alzheimer's Disease • CNS Disorders

A Phase I Study of AV-1959R, an Amyloid Beta Vaccine in Healthy Participants (ANZCTR) - P1 | N=16 | Recruiting | Sponsor: Arvax Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024

Enrollment open • Trial initiation date • 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

A Phase I Study of AV-1959R, an Amyloid Beta Vaccine in Healthy Participants (ANZCTR) - P1 | N=16 | Not yet recruiting | Sponsor: Arvax Pty Ltd

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

The Institute for Molecular Medicine has Received a Total $7.7M From NIH to Develop a First-of-its-Kind Vaccine Targeting Both Hallmarks of Alzheimer's Disease (PRNewswire) - "The Institute for Molecular Medicine (IMM)...today announced that it has been awarded an additional $3 million to the previously awarded $4.7 million grant from the National Institutes of Aging (NIA) of the NIH. The funding will support the manufacturing of a first-of-its-kind clinical cGMP grade dual vaccine, Duvax, that targets both pathological hallmarks of Alzheimer's disease (AD), amyloid beta plaques (Aβ) and neurofibrillary tangles (tau)....The additional funding is being used to manufacture a clinical grade recombinant protein vaccine targeting pathological Aβ, AV-1959R, and test its safety in animal models of AD. This vaccine will be tested in 2022 in a clinical setting. Importantly, the additional funding will also be used to manufacture Duvax for use in phase 1 trials that are expected to be completed in 2023."

Commercial • Financing • Alzheimer's Disease • CNS Disorders

Testing a MultiTEP-based combination vaccine to reduce Aβ and tau pathology in Tau22/5xFAD bigenic mice. (PubMed, Alzheimers Res Ther) - "AV-1959R and AV-1980R formulated with Advax adjuvant are immunogenic and therapeutically potent vaccines that in combination can effectively reduce both of the hallmark pathologies of AD in bigenic mice. Taken together, these findings warrant further development of this vaccine technology for ultimate testing in human AD."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders