IMM, VGXI Partner, Announces $12 Million NIH Grant to Support Phase 1 Clinical Trial of DNA Vaccine for Prevention of Alzheimer’s Disease


VGXI is honored to continue to support IMM and its collaborators with quality GMP plasmid manufacturing services…We look forward to enabling successful first-in-human clinical trials for the preventive Alzheimer’s vaccine AV -1959D from IMM.

VGXI, Inc., an industry-recognized contract development and manufacturing organization (CDMO) for nucleic acid-based biopharmaceuticals, including DNA vaccines and gene therapies, announced that its partner, the Institute of Molecular Medicine (IMM), recently received a $12 million grant from the US National Institute on Aging (NIA) division of the US National Institutes of Health (NIH) to support the clinical trial of IMM beta-amyloid (Aβ) vaccine for the prevention of Alzheimer’s disease (AD). VGXI has been selected by IMM as its exclusive GMP plasmid manufacturing partner supporting the clinical supply of IMM’s DNA vaccine, AV-1959D.

IMM is a non-profit organization as well as their incubated spin-off Nuravax dedicated to the development of safe and effective MultiTEP-based vaccines against neurodegenerative disorders, including Alzheimer’s disease. According to the Alzheimer’s Association annual report, in 2022, approximately 6.5 million people over the age of 65 in the United States are living with Alzheimer’s dementia, and more than 47 million people could have the disease. asymptomatic preclinical Alzheimer’s disease.

VGXI initially partnered with IMM in 2018 providing the first GMP production batch for AV-1959D. The DNA vaccine is designed to induce an immune response against Aβ and has demonstrated the potential to inhibit Aβ aggregation and significantly delay disease progression in preclinical studies. An additional clinical production run for AV-1959D is currently underway at VGXI’s facilities in Texas, and the therapy is expected to enter Phase 1 clinical trials in the United States in the second quarter of 2022.

“VGXI is honored to continue to support IMM and its collaborators with quality GMP plasmid manufacturing services,” said Young Park, CEO of VGXI. “We look forward to enabling successful first-in-human clinical trials for IMM’s preventive Alzheimer’s vaccine AV-1959D.

Dr. Michael Agadjanyan, IMM Vice President and Head of the Immunology Department, said: “In this phase 1, multicenter, double-blind trial, we will study the safety and immunogenicity of the AV-1959D vaccine in subjects with early AD”.

Read IMM’s full 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 track record of successfully 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 examinations by several international regulatory bodies. 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. To learn more, visit https://www.vgxii.com.

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 mRNA manufacturing and development. GeneOne maintained a focus on vaccines against emerging infectious diseases to meet global needs, including in resource-limited regions. Its portfolio of small molecule immunomodulators addresses diseases such as the prevention of bacterial and viral diseases of the upper respiratory tract and the treatment of autoimmune and inflammatory diseases. GeneOne has three COVID-19 products 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 inflammation and clinical effects. worsening for people infected with COVID-19 (Phase II).

VGXI, Inc., a GeneOne company located in The Woodlands, Texas, is the world’s leading CDMO for manufacturing cGMP DNA plasmids.

For more information, visit http://www.genels.com.

ABOUT IMM

The Institute of Molecular Medicine (IMM) is a non-profit organization established with the goal of understanding, preventing and curing chronic human diseases, including neurodegenerative disorders. Based in Orange County, California, IMM and Nuravax, a biotechnology company licensed from IMM’s patented technology, are advancing MultiTEP, a universal vaccine platform technology that supports the development of multiple designs vaccines based on DNA, RNA or recombinant proteins.

CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS

The materials in this press release contain information that includes or is based on forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe” and other words and terms of similar meaning within the scope of a discussion of potential future events. , circumstances or future operational or financial performance. In particular, these include statements relating to future actions, potential products or product approvals, future performance or results of current and anticipated products, sales efforts, expenditures, the outcome of contingencies such as legal proceedings and financial results. Some or all of our forward-looking statements here or in other publications may prove to be incorrect. They may be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many of these factors will be important in determining our actual future results. Therefore, no forward-looking statement can be guaranteed, and forward-looking statements may be affected by factors, including general market conditions, competitive product development, product availability, current and future competition from branded products and generics, federal and state regulations and laws, manufacturing issues, timing of elimination of commercial purchases, patent positions, litigation and investigations. Our actual results may vary significantly and there is no guarantee as to the performance or valuation of GeneOne shares. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information about these cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. However, you are advised to consult our reports for any other disclosures we make on related matters.

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