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Tolerx to collaborate on first-in-class cancer antibody

Published on 02/12/10 at 11:52am

US biopharma company Tolerx is to work with a non-profit cancer research fund to develop its first in class antibody treatment for cancer.

The drug in question is 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 tumour necrosis factor receptor) candidate to enter human clinical trials.

The Cancer Vaccine Acceleration Fund (CVAF), a non profit programme of the Cancer Research Institute established in partnership with the Ludwig Institute for Cancer Research, 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. 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.  

After completing the phase I 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 collaborators say 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 organisations, and biopharma companies can leverage each of their unique strengths to expedite the development of important new medicines for patients."

"Based on pre-clinical 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, a 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 I study.


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 anti-tumour immune response via activating tumour-antigen-specific T effector cells, as well as abrogating the suppression induced by inappropriately activated T regulatory cells.

In pre-clinical studies, TRX518 achieved its targeted effect without compromising normal immune function, and pre-clinical 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.  

The Cancer Vaccine Acceleration Fund (CVAF) aims to help bridge the significant funding gap that exists in the early stages of clinical trials. Frequently referred to as the ‘valley of death’ companies are often hampered by lack of proper funding, and often means promising molecules have to be abandoned.

Tolerx, based in Cambridge, Massachussetts, specialises in developing drugs 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 III development for the treatment of type I diabetes that is partnered with GlaxoSmithKline.  

TRX1, a phase I candidate, is a nonlytic anti-CD4 antibody that is being developed for the treatment of aberrant or untoward immune responses.  Tolerx also has three pre-clinical 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.

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