NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the initiation of a double-blind, randomized, placebo-controlled Phase 2 clinical study of its first IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, indoximod, in patients with metastatic breast cancer. The Phase 2 clinical study will evaluate indoximod as a new approach to treating cancer by administering this novel IDO pathway inhibitor, designed to counteract a key mechanism by which tumors evade immune-mediated destruction, in combination with a conventional cytotoxin, docetaxel. This Phase 2 clinical study follows the successful Phase 1b dose-escalation study of indoximod in patients with advanced solid tumors in which a favorable safety profile and promising early signs of activity were observed. Indoximod is the most advanced product candidate to enter clinical trials based on NewLink's proprietary IDO pathway inhibitor platform for small-molecule, orally bioavailable cancer immunotherapies.
"There is significant unmet need for new approaches that may offer more effective treatment options for patients with metastatic breast cancer, a leading cause of death in women in the United States," said Hatem Soliman , MD, a medical oncologist specializing in breast cancer in The Center for Women's Oncology at Moffitt Cancer Center and the principal investigator for this study. "Indoximod has demonstrated promising safety, pharmacokinetic and biologic activity in earlier clinical studies and we look forward to increasing our understanding of its potential in metastatic breast cancer with this robust Phase 2 study designed to evaluate the activity of indoximod in combination with a conventional 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.
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