A New Frontier in Medicine

Antibodies are an important part of the body's natural defense system and are normally produced by our immune system to help our bodies fight disease. Antibodies are proteins that seek out, recognize and bind to a particular site on cells, viruses and other organisms in a highly specific manner. This specificity makes antibodies useful in the treatment of many types of disease, and antibodies have relatively few side effects since they are a part of the body's own natural disease fighting system. Our immune system however, does not normally make antibodies to our own cells, such as cancer cells. Therefore, for conditions such as cancer or autoimmune diseases, it is necessary to create special antibodies to guide the immune system. In addition, antibody products generally have a shorter development time when compared with typical small molecule drug development.

Medicine is entering the Age of Antibodies

Worldwide, pharmaceutical and biotechnology companies, as well as universities, are exploring monoclonal antibody technology to develop new therapeutic and in vivo diagnostic products. Hundreds of antibodies are in development for the treatment of virtually every life-threatening or debilitating disease. Antibodies are a major category of biotechnology products being tested in human clinical trials.

Therapeutic antibody products are currently on the market for a variety of indications, including cancer, heart disease, and transplant rejection. The market for therapeutic monoclonal antibodies is one of the most dynamic and commercially attractive sectors within the healthcare industry. Monoclonal antibodies are forecast to comproise the largest portion of sales growth at the fastest rate across the entire pharmaceutical industry.  Global sales of monoclonal antibodie sreached $32.2 billion in 2008 and are forecast to increase to $58 billion in 2014. (Datamonitor: "Monoclonal Antibodies: Update 2009").

Evolution of Antibody Products

A monoclonal antibody is a type of antibody produced from a single cell known as a hybridoma. All antibodies produced by the hybridoma are identical and bind to the same specific target in the same way. Until recently, antibody-based products have typically contained mouse or other animal proteins. Such antibodies have the potential to elicit allergic responses or other complications when introduced into human patients.

The original monoclonal antibodies were made in mice and contained entirely murine (mouse-derived) proteins. Early clinical trials with murine antibodies highlighted their disadvantages: many mouse monoclonal antibodies cannot interact efficiently with the human immune system; murine antibodies are recognized as foreign by the human body, typically leading to rapid clearance, especially upon re-treatment; and the mouse proteins contained in the antibodies can cause allergic reactions in some people.

To avoid these complications, some murine antibodies have been re-engineered to remove the majority of their mouse protein sequences, creating chimeric or humanized monoclonal antibodies. The time-consuming humanization process can decrease the binding strength of the original antibody. Chimeric and humanized antibodies still retain some foreign protein sequences.

Fully Human Antibodies

	HuMAb       Antibodies
	100% Human

Genmab has the ability to create fully human monoclonal antibodies in transgenic mice by employing the patented HuMAb-Mouse® technology licensed from Medarex, Inc., a wholly owned subsidiary of Bristol-Myers Squibb. There is no need to subsequently humanize the monoclonal antibody because the IgG antibodies produced from the HuMAb-Mouse have 100% human proteins. High quality HuMAb antibodies can be rapidly generated in a matter of months, have demonstrated high-affinity binding, and can be selected to bind to naturally occurring human materials, tumor cells and infectious agents.