Phage Biotechnology Corp.

Products: Single Chain Antibodies

Phage has recently made a significant breakthrough by showing that the Phage bio-manufacturing technology can produce single chain antibodies. This is an important achievement and has great commercial potential as outlined below.

Background:

The present success of therapeutic antibodies is based on their specific targeting properties and there low toxicity. A drawback is the significant cost to manufacture these antibodies and a shortage of production facilities.

Single chain antibodies display the same specificity as monoclonal antibodies but are one-fifth the size. This feature allows them to be manufactured in bacteria, as opposed to mammalian cells, which provides an enormous cost of goods savings. Also, the small size of these antibodies allows alternate forms of administration besides the traditional IV route, including inhaled forms of single chain antibodies. Currently, there are over 10 single chain antibodies in various stages of clinical trials for cardiovascular, cancer and autoimmune indications. Given the cost-savings advantage in the commercial-scale production of single chain antibodies, it is possible that one day they will replace most monoclonal antibodies in medical practice.

Phage's Single Chain Antibodies:

To demonstrate that the Phage protein manufacturing technology could be applied to the production of single chain antibodies, we chose to develop a single chain antibody to interferon alpha 2b. We were able to produce a soluble, active single chain antibody at a yield of 1 gram/liter. We believe that this will give us a manufacturing edge over other producers of single chain antibodies.

Monoclonal antibodies must be manufactured in animal cells. To keep animal cells alive and healthy, and to remove any contaminating animal viruses from the final product, is an incredibly complex, expensive and time-consuming process. In this case, the cost savings afforded by the Phage process are even more amplified. We estimate that the cost to produce single chain antibody drugs by the Phage process will be on the order of 50-100 times cheaper than producing monoclonal antibodies in animal cells. This will permit Phage to offer these therapeutics at a substantial discount to gain market share. In addition, only the Phage manufacturing process can produce these drugs in a soluble, biologically active form in bacteria. All other bacterial manufacturing systems would require a refolding of the single chain antibody drug, increasing the cost, time to manufacture, and possibly compromising the quality of the final drug product.

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