[GTCB has the lowest valuation I have ever seen for a company with a pending BLA/NDA in a major jurisdiction. I have been accumulating shares. For background info, see #msg-2818560, #msg-2865379, and the encompassing threads.]
>> GTC BIOTHERAPEUTICS BEGINS PROPRIETARY DEVELOPMENT OF AN AGONISTIC ANTIBODY TO CD137 AS A TREATMENT FOR CANCER
COLLABORATION WORK WITH MAYO CLINIC TO BE SUBSTANTIALLY FUNDED BY FLAIR-SBIR GRANT
FRAMINGHAM, MA - May 4, 2004 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has entered into agreements with Mayo Clinic to begin preclinical development of an agonistic antibody to CD137 as a potential therapeutic for solid tumors. The antibody was identified and underwent earlier stage research at Mayo Clinic. The agreements define a collaborative relationship with Mayo Clinic to support GTC's development program. GTC's initial development work will be substantially funded by a recently awarded Phase I grant from the National Cancer Institute of the National Institutes of Health under the Flexible System to Advance Innovative Research For Cancer Drug Discovery by Small Business of the Small Business Innovative Research program (FLAIR-SBIR). GTC will produce and purify the CD137 antibody and Mayo Clinic will collaborate on the preclinical testing.
"The CD137 program provides GTC with an opportunity to apply our technology platform to an antibody that may require large production volumes, assuming successful evaluations of activity and safety," stated Geoffrey F. Cox, Ph.D., Chairman and Chief Executive Officer of GTC. "This is yet another example of GTC's ability to leverage its technology platform to develop innovative therapeutic proteins."
"Based on substantial preclinical evidence, the CD137 program has exciting potential to treat patients with solid cancers," stated Scott Strome, M.D., Associate Professor of Otolaryngology at Mayo Clinic.
The collaboration between GTC and Mayo Clinic will provide GTC with rights to any patents that may issue under the patent applications that cover the CD137 antibody. Under the agreement, GTC has two years to exercise an option for an exclusive license to these patents. Mayo Clinic will provide oversight of the preclinical evaluations. GTC will produce two forms of the antibody that will be tested for bioactivity in human tumor models, and will seek additional grants to develop clinical production and testing, if appropriate, based on the results of the preclinical evaluations.
CD137, also known as 4-1BB, is a member of the tumor necrosis factor/nerve growth factor family of receptors and is a surface glycoprotein found on certain cells of the immune system. The agonistic antibody binds to and stimulates CD137 resulting in the strengthening of the otherwise weak immune response to tumors.
A solid tumor is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancerous), or malignant (cancerous). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumors.
About GTC Biotherapeutics
GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC has three internal proprietary products in its pipeline and a portfolio of external program production opportunities. GTC's lead program is ATryn®, its recombinant form of human antithrombin. A Market Authorization Application was recently accepted for review by the European Medicines Evaluation Agency for the use of ATryn® in patients with a hereditary antithrombin deficiency. In addition to the ATryn® program, GTC is developing a recombinant human serum albumin and a malaria vaccine. In its portfolio of external programs, GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional bioreactor systems. GTC's external program collaborations are developing transgenic versions of products such as monoclonal antibodies and immunoglobulin fusion proteins for conditions such as rheumatoid arthritis, HIV/AIDS and cancer. One of the external programs recently entered clinical trials with a transgenically produced product. Additional information is available on the GTC web site, http://www.gtc-bio.com. <<
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