Tolerx Announces Achievement Of Milestones Upon Anti-CD4 Antibody Program Advancement And Initiation Of Phase 1 Clinical Trial

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 06 Aug 2008 - 1:00 PDT

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Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for the treatment of immune-mediated diseases, announced that Genentech, a collaborator, has moved a modified version of TRX1, MTRX1011A, an anti-CD4 monoclonal antibody, into a phase 1 clinical trial that has begun enrolling patients. The clinical trial is evaluating the safety and tolerability of both single and multiple doses of MTRX1011A. Under the terms of the collaboration agreement between Tolerx and Genentech, Tolerx realized milestones in the first quarter of this year upon selection of the antibody for further development within Genentech's clinical pipeline and upon IND filing. The initiation of the Phase 1 clinical trial resulted in the realization of an additional milestone by Tolerx.

Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx, commented, "We are extremely pleased that our collaboration with Genentech has resulted in the continued advancement of the program, and we look forward to continued progress."

Tolerx and Genentech entered into a collaboration in 2002 to develop and commercialize anti-CD4 monoclonal antibodies. Pursuant to this arrangement, Genentech has the right in all indications to develop, manufacture and commercialize such anti-CD4 monoclonal antibodies. Tolerx will receive additional milestone payments upon further successful development by Genentech of the anti-CD4 monoclonal antibodies in autoimmune or other indications. Tolerx may receive royalties on worldwide net sales of the anti-CD4 monoclonal antibodies that Genentech successfully develops. In lieu of receiving royalties on product sales in the United States, Tolerx has the option to participate in a loss and profit sharing arrangement with Genentech.

About MTRX1011A

MTRX1011A (a modified version of TRX1) is a humanized monoclonal antibody that binds to and down modulates the CD4 receptor found on both effector and regulatory T cells. MTRX1011A is designed to block the activation and function of T effector cells and to favor dominance of T regulatory cells. This unique mechanism of action has the potential to ameliorate autoimmune disease symptoms not only through its direct action on pathogenic CD4 T cells, but by impacting downstream effects of CD4 T cells such as B cell autoantibody production.

About Tolerx

In addition to the anti-CD4 monoclonal antibody program, Tolerx is currently developing otelixizumab, an anti-CD3 monoclonal antibody, for the treatment of autoimmune disease, specifically, type 1 diabetes with its collaboration partner, GlaxoSmithKline. Tolerx is also engaged in preclinical development of new monoclonal antibody product candidates that engage the body's immune system and promote and enhance immune responses. These antibodies are being assessed for potential benefit in the treatment of cancer, chronic viral diseases, and as an adjunct to vaccines. For more information, please visit http://www.tolerx.com.

Safe Harbor Statement

This press release contains certain statements that are preceded by, followed by, or that include the words "look forward," "will receive," "is expected to," "may have," "potential benefit" or similar expressions or the negation thereof. Such statements, which are not historical facts, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements regarding Genentech's activities with respect to further development of MTRX1011A, the realization by Tolerx of any additional payments related to MTRX1011A and the anticipated clinical progress and development of MTRX1011A are all forward-looking statements. Such forward-looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of Tolerx to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Factors and risks that may affect the forward-looking statements include the results of this and future clinical studies, the ability to obtain regulatory approvals for MTRX1011A, the introduction and impact of competing therapies by other companies and the dependence of Tolerx upon Genentech for further development of MTRX1011A. These statements reflect the view of Tolerx as of the date of this press release, and Tolerx undertakes no obligation to update or revise any forward- looking statements to reflect events or circumstances after the date of this press release.

Tolerx, Inc.
http://www.tolerx.com