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NewLink Genetics Presents Positive Phase 2 Data on Novel Immunotherapy, Tergenpumatucel-L, in Non-Small Cell Lung Cancer at the ASCO 2013 Annual Meeting
Date:6/1/2013

AMES, Iowa, June 1, 2013 /PRNewswire/ -- NewLink Genetics Corporation (NASDAQ: NLNK), an oncology-focused biopharmaceutical company specializing in immunotherapy, today announced results from a Phase 2 clinical study with tergenpumatucel-L. The study evaluated the safety and activity of tergenpumatucel-L in 28 previously treated patients with metastatic or recurrent non-small cell lung cancer (NSCLC).  All patients in the study received tergenpumatucel-L as a single agent, which resulted in long term stable disease (>/= 16 weeks) in 8 of the 28 patients, including one patient who survived 50 months. Median overall survival of 11.3 months with tergenpumatucel-L as a single agent was also encouraging in this patient population. Sixteen of the patients whose disease progressed following tergenpumatucel-L therapy received salvage chemotherapy. The partial response rate was 31 percent (5/16) and an additional 25 percent (4/16) achieved stable disease, suggesting that tergenpumatucel-L enhanced the response rate of the salvage chemotherapy. The safety and tolerability of tergenpumatucel-L was demonstrated in the study with no serious drug related (grade 4) adverse events reported; the most frequent drug related adverse events reported in the study were skin reactions at the injection sites.

NewLink is currently conducting a Phase 2b/3 trial comparing tergenpumatucel-L to docetaxel for patients with previously treated NSCLC. This study will compare the response rates of follow-on chemotherapy for patients whose disease progresses in either the docetaxel or tergenpumatucel-L arm to further investigate tergenpumatucel-L's potential to produce a chemo-sensitization effect. Tergenpumatucel-L is the second most advanced product in clinical testing from NewLink's HyperAcute platform technology.

"Lung cancer continues to be the leading cause of
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SOURCE NewLink Genetics Corporation
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