Tolerx and the Cancer Research Institute Enter Collaboration to Accelerate Development of TRX518, a First-in-Class Anti-GITR Ant

$1.5 Million in Funding Awarded to Tolerx within Collaborative Research Alliance

CAMBRIDGE, Mass. and NEW YORK, Dec. 1, 2010 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company developing novel therapies by modulating T cell activity, and the Cancer Vaccine Acceleration Fund (CVAF) -- a nonprofit program of the Cancer Research Institute established in partnership with the Ludwig Institute for Cancer Research -- today announced they entered into a collaborative research agreement to support development of Tolerx's drug candidate, TRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells. TRX518 is the first anti-GITR (glucocorticoid-induced tumor necrosis factor receptor) drug candidate to enter human clinical trials.

Through this collaboration, CVAF will provide $1.5 million in research funding to support Tolerx's clinical development of TRX518.  CVAF will be eligible to receive milestone payments from Tolerx if TRX518 obtains FDA approval in the future. As part of the alliance, CVAF will provide Tolerx with access to scientific and clinical resources, including the Ludwig Institute's Clinical Trial Management team and the Cancer Vaccine Collaborative, a network of 19 leading medical research institutions around the world with expertise in designing and conducting cutting-edge immunotherapy clinical trials in cancer.  Upon completion of the Phase 1 study, TRX518 may be evaluated in clinical trials in combination with other therapeutic cancer vaccines that could complement TRX518's effect on T cells.

The collaboration established by Tolerx and CVAF is built around the parties' shared belief that anti-GITR antibodies have significant therapeutic potential in cancer.  "Our scientific leadership selected Tolerx's TRX518 antibody as a priority for support because it represents a powerful mechanism for enhancing and sustaining the immune system's attack against cancer cells," said Adam Kolom, Director of the Cancer Vaccine Acceleration Fund of the Cancer Research Institute.  "This partnership between CVAF and Tolerx is an innovative model for how academic investigators, nonprofit medical research organizations, and biopharma companies can leverage each of their unique strengths to expedite the development of important new medicines for patients."

"Based on preclinical results, we believe the clinical potential for TRX518 is promising and are eagerly looking forward to applying CVAF's extensive experience in cancer immunotherapy clinical trials to support Tolerx's efforts," said Jedd Wolchok, MD, PhD, member of the CVAF leadership team and director of immunotherapy clinical trials at Memorial Sloan-Kettering Cancer Center, who will also be the lead clinical investigator in the TRX518 Phase 1 study.

"We are excited that the Cancer Vaccine Acceleration Fund has recognized the potential of TRX518 through their funding of the program, and we value their scientific and clinical expertise that contributed to the design of the Phase 1 study," said Douglas J. Ringler, VMD, President and Chief Executive Officer of Tolerx.  "This collaboration with CVAF will accelerate our efforts to advance TRX518 in human clinical trials, and we are delighted to work with Dr. Wolchok and CVAF's other world-leading experts in immunotherapies for cancer."

About TRX518

TRX518 is a targeted T cell immunomodulator that activates GITR (glucocorticoid-induced tumor necrosis factor receptor) found on multiple types of T cells and other immune cells. Activated GITR plays a role in directing the antitumor immune response via activating tumor-antigen-specific T effector cells, as well as abrogating the suppression induced by inappropriately activated T regulatory cells.  In preclinical studies, TRX518 achieved its targeted effect without compromising normal immune function, and preclinical models suggest TRX518 may have a reduced risk of causing serious inflammatory side effects that can result from cytokine release.  TRX518 is designed to have activating and sustaining effects on T cells for enhancing the immune system's responses against cancer cells, including responses that may occur with TRX518 alone, as well as complementary responses in combination with other cancer therapies including vaccines.  

About The Cancer Vaccine Acceleration Fund

The Cancer Vaccine Acceleration Fund (CVAF) is a venture philanthropy fund established by the Cancer Research Institute with significant support from a partnership with the Ludwig Institute for Cancer Research.  CVAF is focused on expediting the development of next-generation cancer immunotherapies by providing funding, scientific leadership and valuable clinical resources for phase I and II clinical trials.  CVAF works with leading scientists and clinicians around the world to identify the most promising new cancer immunotherapies, and then partners with biopharmaceutical companies to help lower the initial hurdle to investment, kick-start their clinical development, and generate important new insights into the immunological and therapeutic efficacy of novel cancer immunotherapies.  CVAF seeks to address the significant funding gap that exists in the early stages of clinical trials where the economic risk is the highest, where critical new scientific insights can be garnered most cost-effectively, and where the backlog of promising new immunological cancer drugs is the greatest.    

About Tolerx

Tolerx, Inc., a world leader in the understanding of T cell function, is developing novel therapies intended to treat autoimmune diseases, diabetes, and cancer by specifically modulating T cell activity.  The company's pipeline includes its lead candidate, otelixizumab, a targeted T cell immunomodulator in Phase 3 development for the treatment of type 1 diabetes that is partnered with GlaxoSmithKline.  TRX1, a Phase 1 candidate, is a nonlytic anti-CD4 antibody that is being developed for the treatment of aberrant or untoward immune responses.  Tolerx also has three preclinical candidates, TRX518, TRX585, and TRX385, which enhance immune responses and as such are being evaluated for potential benefit in the treatment of cancer and chronic infections. Tolerx is a privately held company headquartered in Cambridge, MA USA.  For more information, please visit

SOURCE Tolerx, Inc.