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DRUG DEVELOPMENT | December 06, 2007

A Fledgling Drug-making Process

    

Which came first, the chicken or the biopharmaceutical factory?

SUZANNE ELVIDGE

“Understandably, introducing a new animal system to the biopharmaceutical arena garners some skepticism, and we are challenged to get private sector investors to appreciate the advantages and overcome the perceived risks.”
Once upon a time, chickens were known mainly for their contribution to Sunday dinners or, to the younger set, as the main ingredient in a nugget. But if one California biotech succeeds, chickens may soon be just as well known for their biopharmaceutical production capabilities.
 
Origen Therapeutics, founded in 1997 and based in Burlingame, is developing genetically modified chickens to not only discover new human therapeutics but produce them as well—and in a way that is cheaper and faster than more conventional drug fermentation processes. Or so hopes the company. Its chances of success improved in early October when it was awarded a $2-million, three-year grant by the U.S. National Institute of Standards and Technology (NIST).
 
Analysts say Origen’s work could have significant commercial as well as scientific implications. “This work addresses a major biomedical issue—how to produce antibody-based medicines in an easy, cost-effective way,” says Matthew E. Portnoy, program director of the division of genetics and developmental biology at the National Institute of General Medical Sciences (National Institutes of Health). “Beyond that, it will help researchers understand stem cell biology and development—something that holds great value for all sorts of basic studies.”
 
While therapies today are based on monoclonal antibodies, or antibodies produced by one type of immune cell, Origen is focusing on polyclonal antibodies, which are derived from different B cells, or immune cells. The company believes polyclonal antibodies will be more useful because they can recognize more than one epitope while monoclonal antibodies can recognize only one. An epitope is the smallest part of the antigen—an invader such as a virus or bacteria which triggers the body’s immune system—that is recognized by an antibody.
 
Origen is not yet revealing its therapeutic focus, but polyclonals are likely to have potential in allergic diseases, autoimmune disease, infection, and cancers. The company expects to have a lead polyclonal antibody product in early clinical trials around 2012, which is likely to be the first genetically engineered polyclonal antibody created from a fully human DNA sequence to enter the clinic.
 
Financing is one of the company’s greatest challenges. “It will take several years (in part due to the breeding cycle of the birds) before we can take a product into the clinic,” says Robert M. Kay, Origen’s President and CEO. “While the costs of doing this with transgenic chickens is somewhat less than conventional approaches to development of immunotherapeutics, it is still substantial. Understandably, introducing a new animal system to the biopharmaceutical arena garners some skepticism, and we are challenged to get private sector investors to appreciate the advantages and overcome the perceived risks.”
 

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