CAMBRIDGE, Mass., Nov. 29 /PRNewswire/ -- TolerRx today announced that it has entered into an agreement with Abbott for the manufacturing of TolerRx’s TRX4 monoclonal antibody. Under the terms of the agreement, Abbott will perform scale-up and GMP manufacturing of TRX4 for use in clinical trials, as well as supply commercial-grade material to support regulatory submissions and potential commercial launch. Financial terms were not disclosed.
“With the recent efficacy data with TRX4 in type 1 diabetes and our ongoing clinical trials in subjects with type 1 diabetes and psoriasis, this agreement positions TolerRx to ensure adequate supply of TRX4 for pivotal clinical studies and, if approved, for commercial sale,” stated Douglas J. Ringler, V.M.D., President and CEO of TolerRx. “In this regard, we are delighted to have Abbott, a company with demonstrated experience and expertise in the manufacturing of monoclonal antibody products, as our manufacturer.”
“There is synergy between Abbott’s experience, capacity, and technical expertise and TolerRx’s manufacturing needs. We look forward to working with one of the world’s leading health care companies as our manufacturer of TRX4,” stated Mark O’ Mahony, Director of Process Development, Manufacturing and Quality Control for TolerRx.
TRX4 is a monoclonal antibody that binds to a receptor found on all mature T cells called CD3, which is involved in normal T cell signaling. TRX4 is believed to inhibit the function of autoreactive T cells, which are important in propagating autoimmune diseases, while inducing regulatory T cell pathways that promote immunological tolerance and inhibit autoreactive disease activity. TolerRx is currently enrolling subjects in a Phase Ib/II trial of type 1 diabetes and a Phase Ib trial of moderate to severe psoriasis.
About TolerRx
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 monoclonal antibody that has been partnered with Genentech, Inc. TolerRx is also developing new products to induce immunological tolerance for the treatment of autoimmune diseases and to remove tolerance for the treatment of cancer or chronic viral diseases. For more information, please visit http://www.tolerrx.com.
CONTACT: TolerRx, Inc. Thomas A. Shea Chief Financial Officer 1-617-452-1300 tshea@tolerrx.com
TolerRx
CONTACT: Thomas A. Shea, Chief Financial Officer of TolerRx, Inc., +1-617-452-1300, tshea@tolerrx.com
Web site: http://www.tolerrx.com//
