VGX Pharmaceuticals, Inc., a leading developer of novel drugs and vaccines, announced today that it has signed a collaboration and license agreement with VGX International, Inc. The Agreement provides the technical support and manufacturing process technology necessary for VGX International to construct and operate a large-scale cGMP, DNA plasmid manufacturing facility in Korea – its first in Asia. The agreement will also allow VGX Pharmaceuticals additional supply of Phase II clinical through commercial-scale production of cGMP-grade DNA plasmids to meet the increasing demand for its own products and those of its contract manufacturing client organizations around the world.
VGX Pharmaceuticals currently operates a 500-liter scale fermentor in its cGMP, DNA plasmid manufacturing facility in The Woodlands, Texas, and is conducting IND-enabling pre-clinical toxicology studies for three of its DNA plasmid-based product candidates. The candidates include: vaccines for human papilloma virus as a treatment for cervical cancer (VGX-3100); a therapeutic based on human growth hormone releasing hormone (VGX-3200) for cancer-related cachexia; and vaccines for avian influenza (VGX-3400). The Company expects to file Investigational New Drug Applications (INDs) for all three products by June 2008. Additional product candidates are in its robust R&D pipeline.
“Our agreement with VGX International represents the next phase in the expansion of our capabilities to manufacture DNA plasmids for clinical and eventually commercial applications,” said Dr. J. Joseph Kim, President and CEO of VGX Pharmaceuticals. “We will continue to operate world-class manufacturing facilities to meet the increasing demand for our own DNA-based vaccine and therapy product candidates as well as those of our clients.”
Under the terms of the agreement, VGX Pharmaceuticals will license its patented DNA plasmid manufacturing process and cGMP expertise to VGX International exclusively in Asia. VGX Pharmaceuticals will also provide necessary technical support and training for what is planned to be the largest cGMP, DNA manufacturing facility in Asia. The design phase for this facility will commence before the end of 2007.
About VGX Pharmaceuticals
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.
About VGXI Inc.
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 126.96.36.199/~vgxiico2
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