The story begins at the end of the 19th century when Paul Ehrlich, a German physician, postulated that the immune system protected the body against attack from antigens, which are potentially harmful substances, by deploying what he called antibodies. Each antibody was able to locate and bind with an antigen. This lock-and-key concept proved to be true, leading to man-made antibodies, which, like magic bullets, could kill off disease-producing cells and spare healthy cells.

In 1984, two scientists, César Milstein and Georges Köhler, were awardes the Nobel Prize for discovering a way to produce monoclonal antibodies, which were identical antibodies made from cloned cells that could target specific antigens and destroy them. Their impact on healthcare has been profound, and there are now more than 30 monoclonal antibodies on the market. These include cancer treatments, such as Avastin, Herceptin, and Rituxan. There are many more to come.

Monoclonal antibodies are not as sexy as genetic engineering and stem cells are. Widespread use was delayed because the first-generation monoclonal antibodies were derived from the cells of mice or rats. This provoked severe immune reactions in the human body. Gregory Winter, a scientist at Cambridge, UK, was able to develop humanized and later fully human antibodies that overcame this problem. His laboratory did the early work which led to Humira, the world’s best-selling drug, an antibody-based treatment for rheumatoid arthritis.

The journey from laboratory to clinic was more than 30 years for Campath. It was approved as a treatment for leukemia and recently for multiple sclerosis. The drug was renamed Lemtrada, and in 2014, it was approved by the Food and Drug Administration as a treatment for multiple sclerosis. The approval came after an initial rejection by the FDA. Tysabri is another antibody that has been used since 2006 for multiple sclerosis. Rituxan is also used “off-label.” Look for the approval of ocrelizumab this year, and it likely will be available to treat multiple sclerosis in 2016.

For more information, see “The Lock and Key of Medicine: Monoclonal Antibodies and the Transformation of Healthcare” by Lara Marks, published by Yale University Press.

Jack Florin, MD

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