On December 10, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer, reported that this month it reached the enrollment goal for NLG2101, a randomized Phase 2 study of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer. Indoximod is a small-molecule indoleamine 2,3-dioxygenase (IDO) pathway inhibitor that has the potential to disrupt mechanisms by which tumors evade the immune system (Press release, NewLink Genetics, DEC 10, 2015, View Source [SID:1234508524]). Schedule your 30 min Free 1stOncology Demo! "We believe that IDO is an increasingly important target in immuno-oncology, and that targeting the IDO pathway will be a critical component of future immuno-oncology combination therapies," said Charles Link, Jr., M.D., Chairman and CEO of NewLink Genetics. "Completing enrollment in the clinical trial for this combination chemoimmunotherapy is an important step forward in evaluating indoximod in breast cancer."
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IDO pathway inhibitors are a class of immune checkpoint inhibitors akin to the recently developed antibodies targeting CTLA-4, PD-1, and PD-L1 that represent potential breakthrough approaches to cancer therapy. The IDO pathway regulates immune response by suppressing T-cell activation, which enables local tumor immune escape. Recent studies have demonstrated that the IDO pathway is active in many cancers, both within tumor cells as a direct defense against T-cell attack and also within antigen presenting cells in tumor draining lymph nodes, whereby this pathway promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, the IDO pathway may facilitate the survival, growth, invasion and metastasis of malignant cells whose expression of TAAs might otherwise be recognized and attacked by the immune system.
NewLink Genetics has a number of active programs directed at synthesizing inhibitors to the IDO pathway and, additionally, the company has discovered novel tryptophan-2,3-dioxygenase (TDO) specific inhibitors. IDO pathway inhibitors such as indoximod are designed to be used in combination with other therapeutic agents to maximize the body’s immune response against tumors. In addition, NewLink Genetics has entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of GDC-0919, which is currently in Phase 1 clinical development in patients with recurrent or advanced solid tumors.
About the NLG2101 Trial
NLG2101 is a Phase 2, 1:1 randomized study evaluating indoximod in 154 patients with ER/PR +/- and HER2- metastatic breast cancer who have not received any prior chemotherapy in the metastatic setting. The primary endpoint of NLG2101 is progression-free survival after treatment with docetaxel 75 mg/m2 or paclitaxel 80 mg/m2 with or without indoximod.