Paying $45 million in cash, Kirin Brewery Co. Ltd. acquired Hematech LLC for its capabilities of producing bovine-derived human polyclonal antibodies.
Sioux Falls, S.D.-based Hematech opened its doors in 1998, and entered a research collaboration with Tokyo-based Kirin the following year.
"We had technology and expertise for cloning cows and doing genetic modification in cows, and in the bovine immune system," said James Robl, Hematech's president, chief scientific officer, director and co-founder. "They had expertise in manipulating the antibody genes using a microchromosome approach. So we put the two sets of technology together to introduce human antibody genes into cows."
Now, the companies will operate together, with Hematech and its 50 employees remaining at home and continuing as a subsidiary of Kirin. The $45 million brings Hematech's production capabilities of polyclonal antibodies in-house. Kirin already had development and marketing rights to Hematech's products.
In 2002, three years after Hematech and Kirin first started working together, the companies used a human artificial chromosome vector to introduce human antibody genes into bovine cells. Using Hematech's technology, Kirin created cows capable of producing human antibody proteins and bovine antibody proteins. (See BioWorld Today, Aug. 13, 2002.)
Human antibody-producing cows contain full-length human antibody genes, and are expected to help in the development of antibody-based drugs.
"It will be a while before we start seeing things in clinical trials," Robl told BioWorld Today. "We hope to finish up and have a production system in place in the next couple of years. Once that is in place, all of the other parts will be assembled, and we will move as quickly as possible into the preclinical program."
In a separate endeavor, Kirin has developed a human antibody-producing mouse, and is working with Princeton, N.J.-based Medarex Inc. to commercialize that technology worldwide. While mice would be used to develop monoclonal antibodies, cows would help to develop large quantities of polyclonal antibodies, which might have applications in treating antibiotic-resistant infections, immune deficiencies and cancer.
They also could be used in biodefense. Hematech has programs funded by the Department of Defense and the National Institutes of Allergy and Infectious Diseases to develop human polyclonal antibody therapeutics for botulinum toxin, anthrax and smallpox.
Immune-deficient patients are the largest group of people that use human polyclonal antibody therapeutics, but the costs are between $25,000 and $50,000 per year.
If the technology is successful, it could replace the method of producing polyclonal antibodies in which researchers use gamma globulin preparations extracted and refined from human blood serum. They immunize people from certain pathogens, and then collect the antibodies, but "humans don't make very good production factories," Robl said.
First of all, only accepted vaccines can be used, and there is a limit to how many antibodies can be produced.
"What we're trying to do is replace the human as the current production system so we can vaccinate our animals against pathogens for which there are no current vaccines," Robl said. "And with cows, we can produce essentially unlimited quantities of these products and, hopefully, at a reasonable cost."
Robl, a former professor at the University of Massachusetts for 15 years, joined Hematech in 2000. He was the first scientist to clone a transgenic cow, doing so in January 1998, but Hematech uses a newer cloning technology, he said.
In addition to Robl, three others founded Hematech: James Barton, the company's former CEO; Barbara Osborne, of the University of Massachusetts; and Richard Goldsby, of Amherst College.