VGX Pharmaceuticals announced today that it has submitted two separate investigational new drug (IND) applications to the U.S. Food and Drug Administration (FDA) for Phase I clinical studies of VGX-3100 and VGX-3400. Both candidate vaccines are based on VGX’s SynCon™ vaccine technology, and they have been developed using VGX’s integrated DNA Vaccines and Therapies Platform.
VGX-3100 is a DNA-based therapeutic vaccine that has the potential to treat cervical cancer caused by the human papilloma virus (HPV). VGX-3100 utilizes synthetic consensus sequences based on HPV antigens that offer coverage across different viral sub-types (types 16 and 18), which could potentially treat 71% of all cervical cancers. Although prophylactic vaccines for HPV, including Merck’s Gardasil® and GSK’s Cervarix™,have been recently approved, no therapeutic vaccine for HPV has been approved to date. Furthermore, studies suggest that these approved prophylactic vaccines do not have any therapeutic effects in women who are already infected with HPV.
VGX-3400 is a SynCon™ DNA-based preventative vaccine targeting avian influenza (AI). In pre-clinical studies, vaccination with VGX-3400 generated protective levels of hemagglutination inhibition (HAI) titers in 100% of the immunized animals in five separate animal models – mice, ferrets, rabbits, pigs, and rhesus monkeys. Vaccination with VGX-3400 also protected 100% of the animals from an unmatched, pathogenic H5N1 virus challenge in mouse and ferret models. VGX-3400 also induced significant levels of antigen-specific CD8+ killer T cell responses.
“Filing of these INDs with the FDA marks a significant milestone for our Company,” stated Dr. J. Joseph Kim, President and Chief Executive Officer. “Using our vertically integrated product development platform, we have taken three independent product programs from ‘Bench to IND filing’ within 12 months. These accomplishments demonstrate the potential and efficiency of our product development platform.”
VGX Pharmaceuticals’ SynCon™ DNA vaccine antigens are designed by aligning numerous primary sequences and choosing the most common and/or relevant amino acid at each site using high-powered and patented approaches. The gene sequences are then further optimized for expression and immunogenicity. The SynCon™ DNA vaccines in combination with the CELLECTRA® delivery device provide greater levels of cross-reactive immune responses than those produced by more traditional vaccines. In pre-clinical animal studies, delivery of both VGX-3100 and VGX-3400 was improved with the CELLECTRA® device.
About VGX Pharmaceuticals About VGXI Inc. Cautionary Factors That May Affect Future Results
VGX Pharmaceuticals is a biopharmaceutical company with small molecule and biologic product candidates for the treatment of infectious diseases, cancer, and inflammatory diseases. The Company’s clinical development programs include PICTOVIR™ for HIV infection, which is in Phase II clinical trials, and PENNVAX™-B, a DNA vaccine for HIV infection, which is in 2 separate Phase I clinical trials. The Company’s lead compound for inflammatory diseases, VGX-1027, is also in Phase I clinical trials. VGX’s research pipeline includes a new generation of SynCon™ DNA vaccines and therapeutics as well as the CELLECTRA™ electroporator, a patented DNA delivery device. The product candidates and technology programs are protected by the Company’s extensive global intellectual property portfolio. More information about VGX can be found at www.vgxp.com.
VGXI Inc. is a leading provider of DNA plasmid 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 cGMP conditions for client companies’ clinical studies in the US and Europe, and its cGMP and non-cGMP 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. The recently announced research and pre-clinical production services extend the range of high-quality, research grade materials utilizing the same efficient service. This rapid turnaround program provides consistent materials to build a reliable pre-clinical dataset. For information, visit 22.214.171.124/~vgxiico2
Materials in this Web site 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. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use 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 wrong. 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.
About VGXI Inc.
Cautionary Factors That May Affect Future Results