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NewLink Genetics Presents Preclinical Data On New IDO Pathway Inhibitor, NLG919, At AACR 2013 Annual Meeting

AMES, Iowa, April 8, 2013 /PRNewswire/ -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company primarily focused on discovering, developing and commercializing immunotherapeutic products in oncology, announced today that the company presented preclinical data for NLG919, a potent IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, at the American Association for Cancer Research (AACR) 2013 annual meeting.  These data demonstrate that NLG919 potently inhibits the IDO pathway in vitro and in cell based assays, is orally bioavailable and has a favorable pharmacologic and toxicity profile. NLG919 is the second pipeline candidate from NewLink's IDO Pathway Inhibitor technology platform to be announced.  This platform has also produced indoximod ( NLG8189 or D1-MT) which is currently in Phase 2 clinical trials for the treatment of prostate cancer and metastatic breast cancer. Furthermore, NLG919 and indoximod show remarkable synergistic T-cell activation and antitumor activity. 

"These data further support our view that IDO is a complex pathway with critical downstream immunomodulatory effects, and strategies that aim at multiple targets within this pathway may hold the most promise," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink.  "We are encouraged by NLG919's anti-tumor and pharmacological properties and will continue to evaluate it, along with other IDO pathway inhibitors in our preclinical and clinical pipeline, as an innovative approach to harnessing the immune system to treat cancer."

In a poster presentation entitled " NLG919, a novel indoleamine-2,3-dioxygenase (IDO)-pathway inhibitor drug candidate for cancer therapy," NewLink scientists presented preclinical data to demonstrate  NLG919's on target anti-tumor effects as well as favorable oral bioavailability, pharmacokinetic and pharmacodynamic profiles.  

The principal findings reported in the NLG919 study include:
  • NLG919 potently inhibits the IDO pathway in vitro and in cell based assays.
  • NLG919 potently blocks IDO-induced antigen-specific T-cell suppression and restores robust T-cell responses. 
  • NLG919 demonstrates single agent anti-tumor activity.
  • NLG919 and indoximod show synergistic T-cell activation and antitumor activities.
  • NLG919 is orally bioavailable and has a favorable pharmacokinetic and toxicity profile.

About inhibition of the IDO pathway

IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 and PD-1 which represent a potential breakthrough approach to cancer therapy.  The IDO pathway regulates immune response by suppressing T-cell function and enabling 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 expressing TAAs that might otherwise be recognized and attacked by the immune system.  NewLink has a number of active programs directed at synthesizing IDO pathway inhibitors.  These small-molecule, anti-tolerogenic product candidates are intended to counteract this key mechanism by which tumors evade immune-mediated destruction.

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