Antibody Drug Revival
The human immune system is still the best resource for fighting disease. After a decade of failed promise, drugs that exploit it are finally flooding the market.
In this new world of often unbridled pessimism, it’s worth noting that nobody ever guaranteed you could make a living, let alone a good one, by pushing the limits of technology. Take Nils Lonberg, for instance. Lonberg compares his company’s story to Sleeping Beauty’s, but his analogy is not precise. Sleeping Beauty, after all, was lucky enough to sleep through her ordeal. Lonberg and his colleagues were wide awake through theirs.
Lonberg was just a few years out of graduate school in 1989 when he signed on with GenPharm International, a company developing a class of drugs known as monoclonal antibodies-souped-up versions of the proteins produced by the immune system to fight disease. The goal was to genetically engineer a mouse with a human immune system, one that could be used to generate “fully human” monoclonal antibodies.
His timing could hardly have been worse. A series of promising monoclonal-antibody drugs to cure everything from cancer to severe infections were about to turn out to be high-profile failures. One of these, a drug called Centoxin, made by Malvern, PA-based Centocor, was projected to earn billions as a treatment for often fatal septic shock before the U.S. Food and Drug Administration declined to approve its use in 1992. The FDA decision marked the seeming demise of monoclonal antibodies and, at least for a while, of the prospects of the entire biotech industry.
“The short story,” says Lonberg, “is we hunkered down.” The longer story, like Sleeping Beauty’s, does have a happy ending. In the past four years, Princeton, NJ-based Medarex, which purchased GenPharm in 1997, has blossomed. The monoclonal-antibody business now has some 300 employees, a brand new research facility in Milpitas, CA, and 60 hectares in New Jersey where it’s building a huge development center. It also has a half-billion dollars in cash to make ends meet while it develops its technology and its drugs. “We’re on our way,” says Lonberg, who is now senior vice president and scientific director of Medarex.
The same can be said for monoclonal antibodies in general, which are in the midst of a remarkable revival. Technologies to make monoclonal antibodies have finally come of age, and the drugs themselves are being touted once again as potential cures or treatments for the entire spectrum of human illness.
Since 1997, the FDA has approved 10 monoclonal-antibody drugs-constituting a quarter of all biotech drugs on the market-with combined sales of well over a billion dollars a year. And perhaps more telling, one in every five biotech medicines in development is a monoclonal antibody. Even biotech giant Genentech, a South San Francisco, CA, company founded with the goal of producing enzyme and hormone drugs, now finds monoclonal antibodies filling half its development pipeline.
Indeed, the story of monoclonal antibodies is more than a fairy tale; it’s a lesson in the values of persistence and patience. “When we started with monoclonal antibodies ten years ago, the prevailing wisdom in biotech was, Been there, done that, didn’t work,’” says Paul Carter, a researcher with Seattle-based Immunex who helped launch Genentech’s monoclonal-antibody research in 1990. “Now, everybody and their dog wants to get into antibodies.”
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