The National Institutes of Health (NIH) has granted AlexionPharmaceuticals Inc. an exclusive worldwide license to NIH-patenteddiscoveries that eliminate disease-causing T cells by means ofprogrammed cell death, or apoptosis. The rights are for both U.S. andforeign patents.The licensing arrangement follows a Cooperative Research andDevelopment Agreement (CRADA) between New Haven, Conn.-basedAlexion and the National Institute of Allergy and Infectious Diseases(NIAID). It covers therapeutic and diagnostic applications of thetechnology in autoimmune and graft rejection disorders and hasimplications for the treatment of multiple sclerosis (MS).NIAID's discovery, reported in the February 25 issue of Science,showed that the administration of pharmacologic doses of "self-antigens" called apogens causes the targeted T cells to self-destruct.Reengagement by antigen of the receptor on already activated T cellsinduces programmed cell death, decreasing the number of T cells andthe production of lymphokines. Alexion says the technology isparticularly attractive because it selectively eliminates the small andvery specific population of T cells that cause disease, leaving other Tcells intact and functioning normally.Alexion will use the technology as the basis for its Apogen Technologyprogram, which is designed to treat autoimmune diseases by selectivelydestroying T cells that mount immune responses against the body. Inaddition to MS, the company will target myasthenia gravis, insulin-dependent diabetes, and rheumatoid arthritis. Each Apogenbiopharmaceutical will consist of the recombinant form of theapoptosis-inducing "self-antigen" that is specific for a particulardisease.Leonard Bell, Alexion's president and CEO, said his company has beenworking on the program with NIAID since last summer. He saidAlexion was excited not only by the data that demonstrated that thetechnology blocks disease, but also by demonstration of the mechanismby which it works."The technology represents a perfect fit for our company. We alreadyhave effective complement blockers in vivo. Now we will be able toblock T cells in vivo," Bell said.The company expects to complete preclinical studies of its Apogenproduct this year, and is now scaling up for clinical manufacturing.Diagnostic uses of the technology to identify disease-causing T cells invivo will also be developed, but the primary emphasis will be ontherapeutic use, Bell said. n

-- Philippa Maister

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