Institute for Molecular Medicine Receives $12 Million NIH Grant to Fund Clinical Trials of AV-1959, First Preventive Vaccine for Alzheimer's Disease

ORANGE COUNTY, Calif., March 15, 2022 /PRNewswire/ -- The Institute for Molecular Medicine (IMM), a non-profit organization dedicated to basic and translational molecular research to develop safe, effective vaccines against Alzheimer's disease and other neurodegenerative disorders, today 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.

Up until now, AD therapeutics have mostly focused on treating the underlying pathology after the disease has taken hold. However, once pathology begins and neurons are damaged, it becomes impossible to stop the disease. Current data suggest that a preventive vaccine administered before disease onset could inhibit Aβ aggregation and significantly delay AD.

"Aβ has a central role in the process by which AD develops," said Dr. Agadjanyan, Vice President of IMM and Head of the Department of Immunology. "Our published preclinical data, along with clinical results obtained with monoclonal anti-Aβ antibodies, suggest that only preventive treatment may delay or even halt AD. Due to the need for monthly administration of extremely high concentrations of monoclonal anti-Aβ antibodies, it's impractical to use them for the preventive treatment of healthy people at risk of AD. In contrast, our complementary preventive regimen, comprised of AV-1959D as a prime vaccine and AV-1959R as boost vaccine, could induce high levels of antibodies that inhibit aggregation of Aβ and delay the disease onset in cognitively unimpaired people at risk of AD."

Published studies on both AV-1959D and AV-1959R vaccines have shown that they are safe and immunogenic in mice, rabbits and non-human primates. These vaccines are based on extremely immunogenic and universal MultiTEP platform technology licensed exclusively to Nuravax, which will oversee commercialization, co-development and sub-licensing agreements with biopharmaceutical companies.

About IMM
The Institute for Molecular Medicine (IMM) is a non-profit organization created with the goal of understanding, preventing and curing chronic human diseases, including neurodegenerative disorders. Based in Orange County, California, IMM is advancing MultiTEP, a universal vaccine platform technology that supports the development of multiple vaccine designs based on DNA, RNA or recombinant proteins.

About Nuravax
Nuravax, a biotechnology company incubated by IMM, licensed IMM's patented MultiTEP technology for the commercialization of all vaccines based on this platform. Nuravax aims to create a new segment in the market for the treatment of AD using a safe, highly immunogenic vaccine for cognitively unimpaired people at risk of AD based on a set of accurate, non-invasive disease biomarkers. For more information, please visit www.nuravax.com and follow us on LinkedIn.

SOURCE Institute for Molecular Medicine