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NewLink Genetics Initiates Phase 2 Trial of IDO Pathway Inhibitor, Indoximod, for the Treatment of Metastatic Breast Cancer
Date:4/2/2013

nventional chemotherapy across a number of clinically relevant endpoints."

"Indoximod, an IDO pathway inhibitor is an immune check point inhibitor akin to the recently developed antibodies targeting CTLA-4 and PD-1. IDO can be expressed within both tumor cells and/or antigen presenting cells to create local immune suppression to impair immunological detection and destructions of tumors," commented Dr. Charles Link , Chairman and Chief Executive Officer of NewLink. "We are excited about the promising approach of using novel therapies, like indoximod, to harness key mechanisms of the immune system to enhance the body's cancer-fighting abilities and enhance the effect of other therapies. NewLink intends to pursue this strategy as we advance other clinical candidates from our IDO pathway inhibitor platform as well as our novel candidates from our HyperAcute immunotherapy platform."

This randomized, double-blind, placebo-controlled Phase 2 clinical study is designed to evaluate the safety and efficacy of indoximod in combination with docetaxel as compared to docetaxel alone in up to 120 patients with metastatic breast cancer. Study endpoints include progression-free survival, objective response rate, median overall survival and evaluation of pharmacodynamic tumor markers, in addition to safety. For more information about the study please refer to www.clinicaltrials.gov

About indoximod and inhibition of the IDO pathway

IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitors, also known as one of the key class of checkpoint inhibitors, represent a potential breakthrough approach to cancer therapy using small-molecule, anti-toleragenic product candidates intended to counteract a key mechanism by which tumors evade immune-mediated destruction. IDO is an enzyme that regulates immune response by suppressing T-cell function and enabling local tumor immune escape.
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SOURCE NewLink Genetics Corporation
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