Replies to post #1060 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Thanks for posting the article. The crux of it is this excerpt:

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…it's not clear yet that Symphogen's technique will pass regulatory authorities' standards for consistency. “The authorities are going to ask them to characterize the antibodies individually,” says Yann Echelard, vice president of R&D at GTC Biotherapeutics in Framingham, Massachusetts. If they can't put the same amount of each antibody into every dose, “that's a showstopper for getting approved,” he says.
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If GTC had a long road to regulatory approval for its production platform, it’s reasonable to assume that the polyclonal companies will encounter a longer road.

Moreover, for a variety of practical reasons, animal serum does not begin to compare to milk as a source for therapeutic proteins.

[DewDiligence]

Hematech Reports Development of Prion-Free Cows

[Hematech, a subsidiary of Japan’s Kirin Brewery, is a longstanding player in transgenics but is not close to having an approved product. Their emphasis is on polyclonal antibodies.]

http://biz.yahoo.com/bw/061231/20061231005002.html?.v=1

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Sunday December 31, 1:03 pm ET

Hematech Scientific Team "Knock Out" Prion Protein Gene in Cattle

SIOUX FALLS, S.D. & TOKYO--(BUSINESS WIRE)--Hematech, Inc (a subsidiary of the Kirin Brewery Company, Ltd) and Kirin Brewery Company, Ltd, announced today, in a report published in Nature Biotechnology, the production of healthy prion protein-knockout cows. Prion protein is a natural cellular protein that can become misfolded into infectious particles and cause bovine spongiform encephalopathy (BSE, or "mad cow disease") and a lethal variant of Creutzfeldt-Jakob disease (vCJD) in humans. Healthy prion protein-free calves should be useful in investigating the function of normal cellular prion protein and the nature of prion diseases. Additionally, the cows should be useful as a source of prion protein-free products.

Hematech is developing a bovine system for production of human polyclonal antibodies. As part of this effort a novel gene targeting system was developed and published in Nature Genetics in June 2004. This gene targeting system was used to produce the prion protein knockout calves reported in the current study.

"By knocking out the prion protein gene and producing healthy calves, our team has successfully demonstrated that normal cellular prion protein is not necessary for the normal development and survival of cattle. The cows are now nearly two years old and are completely healthy," stated James M. Robl, Ph.D., President and Chief Scientific Officer of Hematech. "Hematech has already successfully produced knockout cattle using the sequential gene targeting system. We anticipate that prion protein-free cows will be useful models to study prion disease processes in both animals and humans."

According to the Food and Drug Administration's Center for Food Safety & Nutrition, prions are associated with a group of diseases called Transmissible Spongiform Encephalopathies (TSEs). In humans, the related illness, which is suspected of being food-borne, is vCJD. The human disease, vCJD, and the cattle disease, BSE, also known as "mad cow" disease, both appear to be caused by a mutant form of prion protein. After an extended incubation period of years, these diseases result in irreversible neurodegeneration. (http://www.cfsan.fda.gov/~mow/prion.html)

Details of the methods Hematech used to generate the prion protein gene knockout calves can be found in the Advanced Online Publications on the Nature Biotechnology website, http://www.nature.com/nbt (Kuroiwa, Y et al. Production of cattle lacking prion protein. Nature Biotechnology Published Online December 31, 2006; DOI: 10.1038/nbt1271).

About Kirin Brewery Company, Ltd

Kirin, established in 1907, is one of Japan's largest beer brewers. In more recent years Kirin has expanded its business beyond its traditional domestic beer operations to develop a strong portfolio of businesses in pharmaceuticals, overseas alcohol beverages, soft drinks and other areas. Kirin Brewery's Pharmaceutical Division is applying its expertise in biotechnology towards the development of therapeutic products focusing in three core fields: kidney disease, cancer and hematology, immune disorder and infectious disease. Kirin developed a novel technology to introduce human chromosome fragments into animals. Kirin has applied this technology in mice and developed a novel human antibody-producing mouse referred to as the TC Mouse(TM). The TC Mouse(TM) system is commercialized, globally, through a strategic alliance with Medarex, Inc.

About Hematech, Inc

Hematech was purchased by Kirin Brewery Company, Ltd in 2005. Hematech is developing a system for production of hyperimmune human polyclonal antibodies. The Company's unique production system utilizes the collection and purification of human antibodies from specially-bred transgenic cattle. Hematech's production system can be used to generate a diversified portfolio of antibody products for therapeutic indications including immune deficiencies, infectious diseases, cancer, autoimmune diseases and biodefense. More information about Hematech and its human polyclonal antibody production system can be found at www.hematech.com.
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[DewDiligence]

Roche Acquires Therapeutic Human Polyclonals Inc. for $56.5M

[THP is a private U.S.-based company that was cited in a 2006 Nature Biotechnology article on polyclonal antibodies (#msg-13789275, bottom). In my opinion, polyclonal antibodies are a questionable idea from a business standpoint for the reasons mentioned in #msg-13789631. Perhaps that’s why Roche is buying the company so cheaply even though this PR says that THP also has expertise in monoclonal antibodies.]

http://biz.yahoo.com/bw/070402/20070401005044.html?.v=1

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Monday April 2, 1:30 am ET

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Roche, the world's largest biotechnology company, has acquired privately held biopharmaceutical company Therapeutic Human Polyclonals Inc. for $56.5 million.

THP, a California-based company with a subsidiary in Germany, is focused on research in human antibody technologies. The company has developed a unique transgenic mammalian platform to create human antibodies. The technology will enable the generation of both monoclonal and polyclonal antibody therapeutics with enhanced efficacy. [A little more color would be helpful here, but THP is private and Roche generally plays its cards close to the vest.]

The acquisition of THP strengthens Roche's expertise in therapeutic antibody research. Roche is a global leader in therapeutic antibodies with its cancer therapies MabThera®, Herceptin® and Avastin®. Roche plans to fully integrate THP into the Roche Pharma Center of Excellence for Protein Research organization in Penzberg, Germany.

"Co-founder Roland Buelow and I are delighted that Roche will be taking THP's human antibody platform to the next stage," said THP co-founder and chief executive officer Wim Van Schooten. "Roche is the ideal company for furthering development of this technology."

Van Schooten and Buelow founded THP to develop and commercialize next-generation human antibody therapies with initial funding and incubation from Research Corporation Technologies Inc. in Tucson, Ariz. In 2002, SangStat Medical Corp. (acquired by Genzyme Corporation in Cambridge, Mass.) joined RCT in continuing to fund development of THP's novel antibody platform.
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