TolerRx, Inc. Raises $35.6 Million To Advance TRX4 In Type 1 Diabetes

CAMBRIDGE, Mass., Aug. 16 /PRNewswire-FirstCall/ -- TolerRx, Inc., a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies to treat patients with diseases of the immune system, announced that it has completed a $35.6 million financing, which included funding from the Juvenile Diabetes Research Foundation (JDRF), the world's largest charitable sponsor of research in Type 1 diabetes. The funds will support the clinical development of TolerRx's lead product, TRX4, an anti-CD3 monoclonal antibody in development for Type 1 diabetes and psoriasis. TolerRx is currently conducting clinical trials of TRX4 in subjects with Type 1 diabetes and plans to initiate a Phase III pivotal trial in 2006.

FrontPoint Partners, LLC, a new investor to the company, led the round which included six other new investors: Mesirow Financial, Swiss Re, QVT Fund LP, IBT Management Corporation (IBTM), Brookstone Capital, in addition to the JDRF funding. Existing investors participating included: Skyline Ventures, Bear Stearns, Sprout Group, Rho Ventures, Artal Services N.V., and HealthCare Ventures.

"Phase II study results demonstrate that TRX4 (ChAglyCD3) is able to preserve beta cell function for up to a year and a half after a short course of therapy," said Chip Skowron, M.D., Ph.D., of FrontPoint Partners. "In addition to reducing insulin need, the preservation of beta cell function will likely result in a significant reduction of the long term complications associated with Type 1 diabetes. In following, TRX4 therapy could provide patients with substantial clinical benefit."

"We are extremely pleased with the enthusiastic reception we received from investors. The partnership with JDRF and the investment by our new and existing investors validates the progress we have made with the TRX4 program and our commitment to bring this novel therapy to patients with Type 1 diabetes," said Dr. Douglas J. Ringler, President and Chief Executive Officer of TolerRx. "These funds, combined with JDRF's support and expertise, will allow us to further execute our plan to move TRX4 into a Phase III pivotal trial in new-onset Type 1 diabetes this year."

"Anti-CD3 therapy has shown great promise for the treatment of Type 1 diabetes. JDRF has financially supported prior clinical studies with TRX4, so our partnership with TolerRx for the clinical development of TRX4 is a natural progression of our commitment to bring new therapies to patients with Type 1 diabetes," said JDRF Executive Vice President for Research, Richard Insel, M.D.

About TRX4

TRX4 is a monoclonal antibody that binds to a receptor component found on all T cells called CD3, which is involved in normal T cell signaling. TRX4 is designed to block the function of autoreactive T-effector cells that attack the body's tissues and cause autoimmune disease. Because T-effector cells and T-regulatory cells have different signaling requirements for activation, TRX4 is expected to suppress autoreactive T cells while promoting T-regulatory cell activity, resulting in a state of immunological tolerance. In addition to Type 1 diabetes, TolerRx is also developing TRX4 for the treatment of psoriasis.

About JDRF

JDRF was founded in 1970 by the parents of children with juvenile diabetes -- a disease that strikes children suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1 billion to diabetes research worldwide. More than 85 percent of JDRF's expenditures directly support research and education about research. JDRF's mission is constant: to find a cure for diabetes and its complications through the support of research.

About TolerRx, Inc.

TolerRx is a biopharmaceutical company specializing in the discovery, development, and commercialization of novel therapies to treat patients with immune-mediated diseases. TolerRx has two antibodies in clinical development: TRX4 in Type 1 diabetes and psoriasis, and TRX1 in cutaneous lupus erythematosus (CLE). TRX1 is a humanized anti-CD4 antibody that is being developed in collaboration with Genentech, Inc. TRX4 is an anti-CD3 monoclonal antibody to which TolerRx owns exclusive rights. TolerRx is also developing new products to induce immunological tolerance for the treatment of autoimmune diseases and to circumvent tolerance for the treatment of cancer or chronic viral diseases. For more information, please visit http://www.tolerrx.com.

Safe Harbor Statement

This press release may contain or incorporate by reference certain statements that are not historical facts, including statements preceded by, followed by or that include the words "may," "believes," "expects," "anticipates," or the negation thereof, or similar expressions, which constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"). All statements that address events, transactions or developments that are expected or anticipated to occur in the future are forward-looking statements within the meaning of the Reform Act. Such forward-looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of TolerRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. For those statements, TolerRx claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. TolerRx will not undertake and specifically declines any obligation to publicly release the result of any revisions that may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

CONTACT: TolerRx, Inc. Thomas A. Shea Chief Financial Officer (617) 452-1328 tshea@tolerrx.com

Source: TolerRx, Inc.

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