XOMA Licenses Recombinant Pharmaceutical Production Technology to Dompe SpA.Business Editors & Health/Medical Writers BIOWIRE2K BERKELEY, Calif.--(BW HealthWire)--Sept. 18, 2001 XOMA Ltd. today announced the granting to Dompe SpA, (Milan, Italy) of a non-exclusive license for the use of XOMA's patented technology for biopharmaceutical production. Dompe is using the technology in developing a fully human Fab fragment Fab fragment n. The portion of an immunoglobulin molecule that binds the antigen. Fab fragment a portion of an immunoglobulin molecule usually obtained by papain digestion, containing one light chain and part of a heavy chain with for radioimmunotherapy of ovarian carcinoma. Production of antibody domains using XOMA's bacterial cell expression system reduces production costs, increases product yields and improves process control in the manufacture of genetically engineered genetically engineered adjective Recombinant, see there proteins. "Relapsing ovarian carcinoma still represents a significantly unmet medical need," said Sergio Dompe, the Italian company's C.E.O. "In close collaboration with the Italian National Cancer Institute in Milan, Dompe is focusing on the research and development of a novel fully human Fab fragment targeting ovarian carcinoma cells. With the XOMA license, we now have access to an essential technology platform for the development of a fully human Fab for radio-immunotherapy of ovarian carcinoma." "We are pleased that Dompe has licensed our antibody expression technology to develop its Fab therapeutic," said Jack Castello, President, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of XOMA. "Our patented technology is fundamental for the manufacture of antibody-based products in bacteria. With the recent increase in interest in antibody discovery and development, our proprietary technologies and development capabilities are more valuable than ever to biopharmaceutical companies developing novel recombinant therapeutics." About Antibody Expression in Bacteria Bacterial antibody expression is an enabling technology used to develop and manufacture, as well as discover and screen, recombinant antibody-based products. XOMA scientists were the first to demonstrate the secretion of antibody domains directly from bacterial cells as fully functional, properly folded molecules. The company has received nine U.S. patents to date relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc aspects of its bacterial cell expression system, including six patents that broadly cover the secretion of functional immunoglobulins from bacteria, including antibody fragments such as Fab and single-chain antibodies. Corresponding foreign patents have also been granted. Bacterial antibody expression is also a key technology used in multiple systems for high-throughput screening High-throughput screening (HTS), is a method for scientific experimentation especially used in drug discovery and relevant to the fields of biology and chemistry. Purpose and method of antibody domains. Expression of antibodies by phage display phage display n. A technique using recombinant DNA technology to create bacteriophages with a desired peptide embedded in the surface of their protein shells. technology, for example, depends upon the expression and secretion of antibody domains from bacteria as properly folded functional proteins. Therefore, access to XOMA's patent estate is necessary for the practice of antibody phage display and other antibody screening applications. XOMA's bacterial cell production system has been licensed to approximately 25 biopharmaceutical developers. They are applying the system to select and produce recombinant proteins Since human recombinants have replaced the animal version in human therapeutics, the prefix of "rh" for "human recombinant" appears less and less in the literature Human recombinants that replaced animal or harvested from human types About XOMA's Biopharmaceutical Technology Portfolio In addition to bacterial cell expression of antibodies and other proteins, XOMA has other key patented technologies available for licensing. The XOMA Human Engineering(TM) (HE(TM)) technology is a novel method to reduce the immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. of an antibody variable region, and an attractive alternative to CDR-grafting methods of antibody humanization Humanization Fusing the constant and variable framework region of one or more human immunoglobulins with the binding region of an animal immunoglobulin, done to reduce human reaction against the fusion antibody. Mentioned in: Alemtuzumab . XOMA has used HE(TM) in its ING-1 and GENIMUNE(TM) products, and offers the HE technology to others to reduce the possibility of an undesirable immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. . XOMA's Gelonin fusion technology helps create targeted therapeutic molecules by genetically fusing gelonin, a XOMA patented ribosome-inhibiting enzyme, to cell-targeting proteins such as single-chain antibodies or Fabs. For example, the GENIMUNE(TM) product takes advantage of three key XOMA technologies. This Human Engineered(TM) single-chain anti-CD5 antibody is genetically fused to gelonin and is manufactured using XOMA's bacterial cell expression technology. GENIMUNE(TM) is in preclinical development for autoimmune indications, such as rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . About Dompe SpA Based in Milan, Italy, Dompe is one of Europe's most integrated and innovative pharmaceutical and biotech companies. Traditionally established in the areas of anti-inflammatory and respiratory pharmaceuticals, Dompe has since expanded its research into biotechnology and, in particular, in antibody-based immunotherapeutic products. About XOMA XOMA develops and manufactures antibody and other protein-derived biopharmaceuticals for disease targets that include cancer, immunological and inflammatory disorders and infectious diseases infectious diseases: see communicable diseases. . Late-stage programs include a collaboration with Genentech, Inc. to develop the Xanelim(TM) anti-CD11a antibody product for psoriasis (Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA ) and kidney transplant rejection (Phase I/II), and an agreement with Baxter Healthcare Corporation to develop NEUPREX(R) (a systemic formulation of rBPI-21) for multiple indications (Phase II/III). Earlier stage programs include: ING-1, a Human Engineered(TM) antibody in Phase I studies in adenocarcinoma adenocarcinoma: see neoplasm. patients; and antibody, protein and peptide compounds to treat autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , immunological cancers, infections and retinal disorders. For more information about XOMA's pipeline and activities, please visit XOMA's web site at www.xoma.com. Statements made in this news release related to the Company's licensing opportunities, current plans for its licensing programs and the scope of its patents, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the availability of licensing candidates, market demand for technology, the ability of licensees to meet their obligations, actions by the U.S. Patent and Trademark Office, and uncertainties regarding the status of biotechnology patents, are discussed in the Company's most recent annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and in other SEC filings. Consider such risks carefully in evaluating XOMA's prospects. |
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