FDA’s Decision to Approve New Treatment for Alzheimer’s Disease

Novel Preventive Vaccine for Parkinson's Disease Would Move into Human Trials

ORANGE COUNTY, Calif., Jan. 10, 2022 /PRNewswire/ -- The new study, led by the Institute for Molecular Medicine (IMM) and the National Institute of Aging in collaboration with the University of California, Irvine, and the University of California, San Diego, describes four vaccines designed to generate high levels of antibodies specific to various regions of pathological α-Synuclein, the protein associated with Parkinson Disease (PD), Dementia with Lewy bodies (DLB), and other synucleinopathies, including Alzheimer's disease (AD). Of these four vaccines, the best results were obtained with PV-1950, which simultaneously targets three B cell epitopes of this pathological molecule, showing the most significant reduction of α-Synuclein and neurodegeneration in the brains of vaccinated hα-Syn D line mice.

Dr. Agadjanyan said, "The development of a safe and immunogenic vaccine targeting all forms of pathological α-Synuclein is IMM's goal. Importantly, our most effective vaccine, PV-1950, generated strong antibody production, reducing pathological α-Synuclein and improving motor deficits in a mouse model of disease is ready to be tested in preventive clinical trials". He continued, "The PV-1950 has two versions – one based on DNA and one on recombinant protein. Complementary prime-boost immunization with heterologous DNA and protein vaccines is an alternative and promising approach to elicit greater antibody responses."
PD is the second most prevalent neurodegenerative disorder of aging that affects both motor and cognitive function. The institute looks to the vaccine-based preventative treatment of neurodegenerative diseases such as PD, DLB, and AD. An immunogenic vaccine could be the most effective way to block/inhibit the aggregation of toxic α-Synuclein protein from the accumulation and spreading in the brains and halt or delay the disease, said IMM.
"α-Synuclein is a neuronal protein that is linked genetically and neuropathologically to various α-synucleopathies, including Parkinson's disease (PD). Once pathology begins, it becomes virtually impossible to stop it, so using MultiTEP platform-based vaccine from IMM Nuravax want to halt or delay the disease in people at risk of α-synucleopathies," said Roman Kniazev.

About the Institute for Molecular Medicine (IMM):
IMM is a non-profit organization with the mission to contribute to the understanding of and the prevention and cure of catastrophic human chronic diseases such as Alzheimer's disease, Parkinson's disease, cancer, fatigue illness, etc. These goals are accomplished through innovative basic and translational research programs.

About Nuravax, Inc.  
Nuravax aims to create a new segment in the market for the preventive treatment of AD and PD. This segment requires the combination of safe and highly immunogenic preventive vaccines for preclinical PD/DLB and AD people based on a set of novel non-invasive and accurate disease biomarkers. The company estimates the size of this market in the United States as ~40 million preclinical AD people at risk of disease.

Cautionary Note Regarding Forward-Looking Statements  
This press release contains forward-looking statements that are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or other similar expressions. In addition, expressions of our strategies, intentions, or plans are also forward-looking statements. Although forward-looking statements contained herein are based upon what Nuravax and IMM believe are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. IMM and Nuravax undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

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SOURCE Institute for Molecular Medicine