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Genencor Scientists Show Reduced Immunogenicity of Modified Interferon-Beta Protein

May 25, 2004
Source: Genencor International, Inc.

Scientists from Genencor International, Inc., have demonstrated in an in vivo model that a new variant of recombinant interferon-beta reduces the immunological response to the protein.  Administration of recombinant interferon-beta is the standard-of-care treatment for Relapsing Remitting Multiple Sclerosis (RRMS) patients, and the production of neutralizing antibodies against interferon-beta may reduce the effectiveness of this treatment in up to 30 percent of RRMS patients.  The Genencor data, published in the current issue of Journal of Immunology, extend studies published earlier this year (Genes and Immunity (5 (1), 1-7, 2004) by providing an in vivo test of the I-mune(R) method for creating reduced immunogenicity protein variants.

Using Genencor's proprietary I-mune(R) assay and platform, the scientists generated a variant of interferon-beta by changing an amino acid at a single position in the immunodominant CD4+ T cell epitope region of the protein.  The immunodominant epitope in the parent protein had been shown in an earlier report published by Genencor scientists to be critical for immunologic responses in both humans and Balb/c mice.

The scientists showed that T cells from mice immunized with the variant and challenged with the parent interferon-beta had significantly lower proliferation than has been seen following immunization with unmodified interferon-beta.  Further, the IgG antibody response to the variant interferon-beta molecule was almost completely absent.  The data showed that the single amino acid change did not disrupt the overall structure of the interferon-beta protein as evidenced by no alterations in antibody-binding epitopes.  Importantly, the resulting variant interferon-beta (known as I129V) was equally active as the original molecule in functional assays.

"Our I-mune assay had identified both dominant and subdominant epitopes within interferon-beta.  The current findings suggest that modification of the immunodominant epitope eliminates the need to modify other subdominant ones, thus reducing work needed to create new generations of important protein drugs," said Mark A. Goldsmith, M.D., Ph.D. Genencor's senior vice president, Health Care.  "We believe that our technology can be used to minimize immunogenicity problems that are frequently encountered in late-stages of protein drug development in the absence of immuno-optimization."

About Genencor

Genencor International is a diversified biotechnology company that develops and delivers innovative products and services into the health care, agri-processing, industrial and consumer markets.  Using an integrated set of technology platforms, Genencor's products deliver innovative and sustainable solutions to improve the quality of life.  Genencor traces its history to 1982 and has grown to become a leading biotechnology company, with over $380 million in year 2003 annual revenues.  Genencor has principal offices in Palo Alto, California; Rochester, New York; and Leiden, the Netherlands.

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995.  These include statements concerning plans, objectives, goals, strategies, future events or performance and all other statements which are other than statements of historical fact, including without limitation, statements containing words such as "believes," "anticipates," "expects," "estimates," "projects," "will," "may," "might" and words of a similar nature.  Such statements involve risks and uncertainties that could cause actual results to differ materially from those projected. Some important factors that could cause actual results to differ include dependence on the efforts of third parties; dependence on new and uncertain technology and its uncertain application to new business ventures; regulatory actions or delays, or uncertainties related to product development, testing or manufacturing; ability to form and maintain strategic alliances; ability to complete certain transactions and realize anticipated benefits from acquisitions; dependence on certain intellectual property rights of both Genencor and third parties; the competitive nature of Genencor's industry; risks of obsolescence of certain technology; and the high risk nature of efforts to develop viable products for the health care market, including the achievement of successful pre-clinical and clinical results.  These and other risk factors are more fully discussed in Genencor's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission.  The forward-looking statements contained in this release represent the judgment of Genencor as of the date of this press release. Genencor disclaims, however, any intent or obligation to update any forward-looking statements.

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