CELL GENESYS ENTERS $30 MIL. HUMAN-MAb PRODUCING MOUSE R&D AGREEMENT

Executive Summary

CELL GENESYS ENTERS $30 MIL. HUMAN-MAb PRODUCING MOUSE R&D AGREEMENT with JT Immunotech to develop and market Cell Genesys' human monoclonal antibody-producing mouse strain and pharmaceuticals derived therefrom, the companies announced June 12. JT Immunotech, a wholly-owned subsidiary of Japan Tobacco, will fund up to $ 30 mil. in Cell Genesys R&D in return for an undisclosed minority equity interest and a seat on the board of directors. Additionally, the agreement provides for a 50/50 joint venture to develop and market human MAb-mouse produced pharmaceuticals deriving from the project. With the JT Immunotech funds, Cell Genesys will complete the development of the Cell Genesys mouse. "Significant progress" has been made toward development of the strain and the project could be completed within the next couple of years, the Foster City, Calif. startup predicted. The antibodies produced by the company's mice are expected to be "broadly applicable" to a wide range of diseases, including arthritis, organ transplant rejection, inflammation, and cancer, Cell Genesys said. The Cell Genesys mouse will contain mouse immune cells with human antibody genes. The technology involves programming new genetic information in the place of certain genes in mouse chromosomes, or homologous recombination. Because the genes responsible for producing antibodies have been "targeted" and altered to resemble human genes, the company asserted, the mouse will respond to human antigens by producing fully human antibodies. The company believes its new strain of MAb-producing mice will produce therapeutic products that will outrival murine antibody products because their products will be less likely to produce a human anti-mouse antibody response (HAMA) and thus can be used over long periods of time for the treatment of chronic illnesses. Cell Genesys also said its mouse will offer advantages over other antibody-producing mice because the strain will retain its rodent immune system. Specifically, the Cell Genesys mouse is an improvement over the SCID/Hu mouse, currently under development by several companies, which carries transplanted human immune cells, Cell Genesys claimed. The transplanted immune systems of SCID/Hu mice, Cell Genesys maintained, "cannot easily recognize human antigens as 'foreign'" and therefore tend not to respond by producing human monoclonal antibodies to combat these antigens. Cell Genesys also believes its mouse will offer an advantage over the "inefficient and time-consuming process" of using recombinant DNA technology to humanize mouse antibody products one antibody at a time. The start-up's long-range business goal is the development of a "universal donor cell," a human cell engineered through homologous recombination that could be transplanted into any patient with a minimal risk of transplant failure. Retinal cells in the treatment of degenerative eye diseases and immune cells to combat serious infections are potential examples of uses for "universal donor cells," the company said.