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BAXTER/IMMUNOLOGY LTD. TO CODEVELOP KIDNEY TRANSPLANT MONOCLONAL

Executive Summary

BAXTER/IMMUNOLOGY LTD. TO CODEVELOP KIDNEY TRANSPLANT MONOCLONAL antibody Anti-CD45, the firms announced Oct. 10. Anti- CD45, invented and owned by U.K.-based Immunology Ltd., is a combination of two monoclonal antibodies that "reduces significantly the body's rejection of transplanted kidneys," the companies said. Unlike other immunosuppressive therapies for organ transplantation, Anti-CD45 is perfused through the prepared donor organ, not administered to the transplant recipient. Baxter Healthcare Corp. will fund the drug's further development and assist with U.S. regulatory issues. In return, Baxter is acquiring the marketing rights to Anti-CD45 in North America and Europe. Baxter and Immunology will "collaborate on future plans to manufacture the drug," the companies said. No other terms of the codevelopment agreement were disclosed. Anti-CD45 efficacy trials in the U.S. and the U.K. are forecast to begin in 1992, and the companies hope to file a U.S. IND within the next year, Immunology Ltd. indicated. FDA gave Anti-CD45 orphan drug status in September 1990. Immunology will supply the samples of Anti-CD45 needed for the clinical trials. According to Baxter and Immunology Ltd., Anti-CD45 reduces the immunogenicity of "passenger leukocytes" in the donated organ. While rodent studies have shown that monoclonal antibodies bind to dendritic cells that are thought to play an important role in organ transplant rejection, the mechanism of action of Anti-CD45 is uncertain. A human trial of Anti-CD45 was published in the Oct. 21, 1989 issue of The Lancet. In that trial, half of the 77 kidney transplant recipients studied received kidney allografts that had been perfused with Anti-CD45, while the other half received placebo-treated kidneys. All patients underwent immunosuppression with cyclosporin (Sandoz'a Sandimmune) and prednisolone before and following the transplant. Of the 39 patients receiving Anti-CD45- treated kidneys, seven (18%) experienced rejection episodes, while 24 out of the 38 patients in the placebo group (63%) had such episodes. No adverse effects were attributed to Anti-CD45. Baxter and Immunology Ltd. indicated that they will pursue a kidney transplant indication first, but will also be studying the use of Anti-CD45 in liver, heart, and pancreas transplantation. Another new immunosuppressant, Fujisawa Pharmaceutical's FK-506, is in Phase III trials for use in liver transplants in the U.S. and Phase II trials for kidney transplantation in Japan. Sandimmune is approved for kidney, liver and heart allogeneic transplants and for treating chronic rejection. The agreement with Baxter will provide a steady supply of cash for startup Immunology, which has no approved products. The company, based in Cambridge, England, was founded in April 1989 and in 1990 raised (BRITISH POUND) 5 mil in equity financing. Immunology Ltd. is headed by Chairman William Duncan, former Deputy Chairman-Technical at ICI Pharmaceutical and VP-Development for Smith Kline & French in Europe. In addition to Anti-CD45, the firm has R&D programs underway for therapies for cervical cancer, viral and autoimmune diseases.
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