Vical Advances RapidResponse(TM) DNA Vaccine Platform Under $6 Million Gran...(facilities. RapidResponse(TM) DNA vac...),Health

RapidResponse(TM) DNA vaccine manufacturing involves a cell-free process and single-step vaccine purification. The process has the potential to be scaled up by simply using larger equipment with no increase in production time, conceivably allowing production of hundreds of millions of doses of DNA vaccine during the earliest stages of an outbreak. Such speed and scale may be crucial in addressing a naturally emerging potentially pandemic disease such as influenza or SARS, an accidental release of a dangerous pathogen such as Ebola virus or Yersinia pestis (plague bacterium) from a biological containment facility, or an intentional release of a weaponized or bioterrorist-modified pathogen designed to cause diseases such as anthrax or smallpox.

Initial research testing demonstrated 100% protection of mice against a lethal challenge with an H3N2 influenza virus after a single 2 microgram dose of Vaxfectin(R)-formulated DNA vaccine produced by polymerase chain reaction (PCR). Next steps in the development of the RapidResponse(TM) DNA vaccine platform will include determination of the lowest effective dose, head-to-head comparison against plasmid DNA vaccine, Vaxfectin(R) formulation optimization, and scale-up in adherence with current Good Manufacturing Practices (cGMP) to production of quantities appropriate for initial human clinical trials.

The PCR process produces a segment of DNA, called a linear expression cassette (LEC), which includes only those DNA sequences essential for eliciting immune responses. The bacterial fermentation process typically used for DNA vaccines produces a closed loop of DNA, called a plasmid, which includes DNA sequences required by the bacteria in the manufacturing process. Vical holds patents in the United States and in other key regions based on the company's discovery that administering polynucleotides such as DNA or RNA to tissues, without the use of viral delivery vehicles, may cause expression of the
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