Texas-based CDMO VGXI, Inc. is excited to announce that its partner, The Institute for Molecular Medicine, has recently been awarded a $12 million NIA grant to support clinical testing of a novel DNA vaccine manufactured by VGXI for the prevention of Alzheimer’s Disease.
The Woodlands, TX – VGXI, Inc., an industry recognized contract developer and manufacturing organization (CDMO) for nucleic acid biopharmaceuticals including DNA vaccines and gene therapies, announced that its partner, The Institute for Molecular Medicine (IMM), was recently awarded a $12 million grant from the U.S. National Institute on Aging (NIA) division of the U.S. National Institutes of Health (NIH) to support the clinical trial of IMM’s beta-amyloid (Aβ) targeted vaccine for the prevention of Alzheimer’s Disease (AD). VGXI has been selected by IMM as its exclusive GMP plasmid manufacturing partner supporting clinical supply for IMM’s DNA vaccine, AV-1959D.
IMM is a non-profit organization as well as their incubated spinoff Nuravax dedicated to developing safe and effective MultiTEP-based vaccines against neurodegenerative disorders including Alzheimer’s disease. According to the Alzheimer’s Association annual report, in 2022, an estimated 6.5 million individuals over age 65 in the US are living with Alzheimer’s dementia, and more than 47 million people may have asymptomatic preclinical Alzheimer’s disease.
VGXI initially partnered with IMM in 2018 by providing the first GMP production batch for AV-1959D. The DNA vaccine is designed to induce an immune response against Aβ, and has demonstrated potential to inhibit Aβ aggregation and significantly delay disease progression in pre-clinical studies. An additional clinical production run for AV-1959D is currently in progress at VGXI’s Texas-based facility, and the therapy is set to enter Phase 1 clinical trials in the U.S. in Q2 2022.
“VGXI is honored to continue supporting IMM and their collaborators with quality GMP plasmid manufacturing services,” stated VGXI CEO Young Park. “We look forward to enabling the successful first-in-man clinical trials for IMM’s preventive Alzheimer’s disease vaccine AV-1959D.”
Dr. Michael Agadjanyan, Vice President of IMM and Head of the Department of Immunology stated, “In this double blind multicenter Phase 1 trial we will study safety and immunogenicity of AV-1959D vaccine in early AD subjects”.
Read the full IMM press release regarding the NIH grant award here.
ABOUT VGXI, INC.
VGXI, Inc., with 20 years of experience, is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. VGXI, Inc. is a GeneOne company.
ABOUT GENEONE LIFE SCIENCE
GeneOne Life Science Inc. (“GeneOne” KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II).
VGXI, Inc., a GeneOne company located in The Woodlands, Texas, is the global leading CDMO for cGMP DNA plasmid manufacture.
For more information, visit http://www.genels.com.
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 along with Nuravax, a biotechnology company licensed IMM’s patented technology, is advancing MultiTEP, a universal vaccine platform technology that supports the development of multiple vaccine designs based on DNA, RNA or recombinant proteins.
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
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Christy Franco, Ph.D.
Sr. Manager, Business Development