Yearly Archives: 2014

VGXI Announces Expansion of its Manufacturing Facility

VGXI announces the expansion of its state-of-the-art cGMP manufacturing facility, located in The Woodlands, TX.

FOR IMMEDIATE RELEASE:
VGXI Facility Expansion

The Woodlands, TX – December 15, 2014 – VGXI announced today the expansion of its state-of-the-art cGMP manufacturing facility. The expansion will include an additional 3,000 square feet of space, with the primary purpose of building a dedicated, small scale cGMP production plant. Once operational, the second facility will provide greater manufacturing capacity and allow multiple client campaigns to run in parallel. As part of the overall expansion plan, the team at VGXI has already begun installation and preparation of a new 40L fermentor to add to its existing fermentation equipment.

“This is an exciting time for the field of gene therapy and DNA Vaccines. As these technologies mature, more and more companies are moving their products into clinical trials and closer to regulatory approval. The use of an experienced manufacturer to supply high quality and purity plasmid DNA at multiple scales will be an important factor in ensuring both safety and efficacy of these products.” – Christy Franco, Business Development Manager at VGXI

Having earned the Vaccine Industry Excellence Award for best CMO in both 2013 and 2014, VGXI is already positioned as an industry leader. The 3,000 sq ft expansion will enable the company to continue to meet the growing global demand for DNA-based pharmaceuticals.

ABOUT VGXI, INC.

With over 15 years of experience, VGXI Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under GMP conditions for clinical trials in the US, EU, Asia 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 is a wholly- owned subsidiary CMO of GeneOne Life Science, Inc. (KRX:011000)

Cautionary Factors That May Affect Future Results – Materials in this Website contain information that includes or is based upon 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 do not relate strictly to historical or current facts and can therefore be identified as such. They include words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of VGX stock. It is also important to read the disclosure notice contained in many of the individual VGX documents available on this Web site as many contain important information on such 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. You are advised, however, to consult any further disclosures we make on related subjects in our reports.

Media Contact:

Christy Franco, PhD

Business Development Manager

Contact

P: 281-466-3790

Logo_QualityTagline_2014_black_transparent

 

Second Generation DNA Vaccines and Delivery Methods

Second Generation DNA Vaccines

DNA vaccines have come a long way resulting in a second generation of vast improvements bringing a surge of interest to the community. In both small and large animal models, second-generation DNA vaccines show that they assist cellular and humoral immune responses. Additionally, research suggests that newer DNA vaccines can more broadly activate CD8+ cytotoxic T cells (CTL) in larger animal models, compared with earlier DNA methods. Inefficient uptake of plasmids by cells has been resulting in low immunogenicity. However, second generation DNA vaccine research has focused on developing novel strategies to enhance transfection efficiency and improve other facets of the DNA platform. These efforts include optimization of the antigens encoded by the plasmids to increase antigen expression on a per cell basis, improved formulation, and inclusion of molecular adjuvants to enhance and direct immune responses.

Delivery Approaches

Since the early 1990’s, the most common delivery for DNA vaccines has been intramuscular injection (IM). This method had a disadvantage of lowered specific immune responses. Therefore, several physical methods of delivery have been explored to increase the transfection efficiency of DNA vaccines, including needle-free approaches, such as particle bombardment and high-pressure mediated delivery, dermal patches, and electroporation (EP). Particle bombardment approaches use a highly pressurized stream to deliver vaccine plasmids on microscopic heavy metal beads. High-pressure mediated delivery is conceptually similar to particle bombardment. High-pressure delivery, the Biojector devices, deliver vaccines by forcing liquid through a tiny orifice to create a fine, high-pressure stream that penetrates the skin. Noninvasive dermal patch delivery utilizes a self-adhesive patch coated with multiple antigen or adjuvant encoding plasmids and a synthetic polymer that forms pathogen-like nanoparticles. Another promising physical method of delivery is EP, or the application of short electrical pulses to the delivery tissue, was initially studied over 25 years ago as a method to enhance the efficacy of chemotherapy agents. It was later discovered that EP also increases the uptake of DNA plasmids by cells, resulting in an increase in antigen production and in vaccine immunogenicity. Significant increases in immunogenicity have been observed while delivering DNA vaccines by intramuscular injection with electroporation, compared with IM alone.  Thus, the use of improved delivery has enabled second-generation DNA vaccines to induce cellular immune responses comparable to viral vectors in nonhuman primates.