http://news.excite.com/news/pr/011023/ma-tolerrx

Tue, Oct 23 10:30 AM EDT
 
CAMBRIDGE, Mass., Oct. 23 /PRNewswire/ -- TolerRx, Inc., a biopharmaceutical company specializing in the discovery and development of therapies that induce and maintain immunological tolerance, today announced the completion of its Series B financing that will finance the development of its lead product and the expansion of its research programs, including the TolerMab(TM) antibody platform. Led by current investor HealthCare Ventures, the $17 million financing includes new investors Skyline Ventures, Rho Ventures and Vertex Management.

TolerRx will use the funds to advance its lead product, TRX1, a humanized monoclonal antibody, into clinical trials for use as a combination therapy to induce tolerance to protein therapeutics, such as Factor VIII and chimeric antibodies, and as a primary therapy in transplantation and certain immune- mediated diseases, such as rheumatoid arthritis and multiple sclerosis. In pre-clinical studies, TRX1 induced antigen-specific tolerance in non-human primates while maintaining immunocompetence and the ability to respond immunologically to newly-presented antigens. TolerRx will also be using the proceeds from the financing to introduce its TolerMab(TM) antibody platform for producing antibodies that are recognized by the body as "self" and thus suitable for use as chronic therapy. In addition, TolerRx will increase its research and development efforts toward identifying new targets and genes involved in tolerance.

"We are very pleased to have such a strong financing round with participation from highly-respected biotechnology venture capital firms. We believe that this is an important endorsement of the development progress that the Company has made and a vote of confidence in the technology platform and product pipeline," said Douglas J. Ringler, V.M.D., President and Chief Executive Officer of TolerRx.

"We see a significant clinical need for new therapies and technologies that can overcome the immune responses associated with many current therapeutics. TolerRx has built a world-class research and development team and a strong relationship with Professor Herman Waldmann and his laboratory at the University of Oxford to accomplish this mission," stated Christopher K. Mirabelli, Ph.D., Chairman of the Board of TolerRx and general partner of HealthCare Ventures.

"We were very impressed with the product candidates, platform technology, and research and discovery engine that TolerRx has been able to generate in a short time. We believe that TRX1 and the TolerMab(TM) antibody platform have significant scientific and commercial potential, and we are pleased to join the investor syndicate," said Yasunori Kaneko, M.D., managing director of Skyline Ventures.

As a result of the closing of the Series B financing, Dr. Kaneko will become a member of the TolerRx Board of Directors, joining Drs. Ringler, Mirabelli, and Waldmann, Wayne Hockmeyer, Chairman of the Board of MedImmune, Inc., Daniel Kisner, President and Chief Executive Officer of Caliper Technologies Corp., and Harold Werner, general partner of HealthCare Ventures.

TolerRx Overview

TolerRx is a biopharmaceutical company specializing in the discovery and development of therapies that induce and maintain immunological tolerance. TRX1, the Company's humanized monoclonal antibody lead product, has induced antigen-specific tolerance in pre-clinical studies of non-human primates and is expected to begin clinical trials in mid-2002. The Company's TolerMab(TM) antibody platform can enable an antibody to become immunologically recognized as "self" while maintaining therapeutic activity for long-term use. TolerRx has four antibody products in pre-clinical development and three discovery and development programs ongoing.

Tolerance

Tolerance is a normal immunological response that the body uses to recognize "self" from "non-self" (foreign agents or antigens). As such, therapies that harness this normal immunological response would have a significant advantage over present immunosuppressive treatment regimes. Clinical settings where tolerance inductive therapies would be beneficial include autoimmunity, transplantation, gene therapy, and situations where chronic biologic therapy induces an interfering immune response to therapeutic proteins such as monoclonal antibodies, clotting factors, enzymes as replacement therapy, and various other recombinant proteins.

TolerRx's approach is unique in that it leverages proprietary technology involving the identification of a fundamental mechanism of immunoregulation to bring therapies that induce long-standing immunological tolerance to patients. The Company's Scientific Founder is Professor Herman Waldmann, Professor of Pathology at the University of Oxford, Head of the Sir William Dunn School of Pathology, and Clinical Director of the Therapeutic Antibody Centre, University of Oxford. Professor Waldmann and his colleagues have carried out pioneering research on the mechanisms responsible for immunological tolerance, and the initial proprietary position of the Company is based upon exclusive licenses to technologies derived from his laboratory.

TRX1

The lead product candidate is TRX1, a humanized monoclonal antibody to a human T cell antigen that when used in an appropriate dosing regime in combination with antigen, induces a long-term antigen-specific tolerance. TRX1 has undergone safety and dose-ranging proof-of-principle studies in non- human primates, and the product was found to be safe, with no adverse clinical effects, and efficacious in inducing immunological tolerance to a foreign soluble protein. The first clinical indications for TRX1 will be situations where administration of a biologic protein therapy induces an interfering immune response. TRX1 will also be evaluated as primary therapy for transplantation and immune-mediated diseases such as rheumatoid arthritis and multiple sclerosis. The Company intends to commence clinical trials of TRX1 in mid-2002.

TolerMab(TM) Antibody Platform

The TolerMab(TM) Antibody Platform is a proprietary new technology that generates therapeutic antibodies that are immunologically recognized as "self" and can be administered repeatedly to treat patients with chronic disease. The TolerMab(TM) process includes a modification of a murine, chimeric or humanized antibody that alters the body's immunological perception of the antibody while leaving all immunological functions of the antibody intact. The resulting TolerMab(TM) antibody escapes immunological attacks against it and can also reduce or eliminate the first-dose cytokine effects typically associated with antibody therapeutics. The TolerMab(TM) technology can be applied to any antibody in a matter of weeks and provides the opportunity for long-standing antibody-specific tolerance and long-term therapeutic use. TolerRx has two TolerMab(TM) antibodies currently in pre-clinical development.

Research and Discovery

TolerRx has established research and discovery programs in the field of T- regulatory cells and dendritic cells, the immunological mediators of tolerance. Through these internal programs and research collaborations with the University of Oxford, TolerRx is identifying novel genes and targets that are differentially expressed on T-regulatory and dendritic cells and that are involved in tolerance pathways. TolerRx believes that genes and targets related to T-regulatory and dendritic cells can provide the foundation for the development of selective and effective tolerogenic therapeutics.

About TolerRx

TolerRx is a biopharmaceutical company specializing in the discovery and development of therapies that induce and maintain immunological tolerance. For further information, please visit http://www.tolerrx.com/

TolerMab(TM) is a trademark of TolerRx, Inc.
 

©2001 At Home Corporation