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. To date, 21 monoclonal antibody products developed by other companies are approved by the U.S. Food and Drug Administration for use as therapeutic products in the United States. Worldwide antibody sales passed USD 14 billion in 2005, USD 19 billion in 2006 and increased to USD 26.3 billion in 2007. 

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. 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.

Genmab is developing human monoclonal antibody-based products to treat cancer, infectious disease and inflammatory conditions such as rheumatoid arthritis (RA). Human antibodies are expected to be particularly useful in these conditions as they should lend themselves to long term therapy without the risk of immune system rejection.