The technology relies on the synthesis of DNA and does not require the use of bacterial fermentation - currently the most common way of making DNA in commercial quantities. The cost and complexity of bacterial fermentation to produce pharmaceutical grade DNA has hindered the development of DNA-based drugs, including vaccines and cancer immunotherapies, according to the company.
The US Patent and Trademark Office filing is called 'Chemo-Enzymatic Synthesis of DNA and Uses Thereof' and, according to CytoGenix, can produce gramme or higher quantities of very high-purity DNA in test tubes or flasks in the lab.
Currently, manufacturers use large fermentation vats of cloned Escherichia coli bacteria to produce DNA by culturing, then rupturing the bacteria to extract the DNA. This process produces great quantities of toxic bacterial contaminants, and sophisticated and expensive purification methods are necessary to remove these toxins.
"This can drive the cost of FDA-approved DNA to as much as $250,000 a gramme or $250,000,000 a kilo," said CytoGenix.
CytoGenix' breakthrough synthesis technology does not use bacteria and therefore produces no bacterial toxins. Dr. Malcolm Skolnick, the firm's president and CEO, said: "Once you eliminate the bacteria, the scale of production and related costs of DNA come way down."
However, he also claimed that the technology transcends economic implications. "More importantly, we have introduced a fundamental improvement to the science of making DNA," said Skolnick.
DNA vaccines are made of DNA 'rings' called plasmids. Scientists design these plasmids to contain instructions that prompt the immune system to identify and destroy a viral or bacterial pathogen.
As with therapeutic DNA, the traditional bacteria-based technology requires that the plasmid contain DNA sequences containing the instructions for its replication in E coli. CytoGenix maintains that these extraneous bacterial genes are not entirely benign and can elicit serious side effects.
"By eliminating the need for this extra DNA, the plasmids are significantly smaller and safer, thus enabling greater drug concentrations. We believe that by eliminating these extra pieces in the DNA plasmid, scientists will now have much more freedom and control in designing better and safer DNA drugs," said Skolnick.
CytoGenix plans to use the technology to produce its own developmental drug candidates, but will also make it available to others through licensing or contract manufacturing.