Investor Relations
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3:56 PM ET on Oct 6, 2015
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NewLink Genetics is an innovative biopharmaceutical company dedicated to pioneering, developing, and marketing novel immunotherapies intended to transform the treatment paradigm for cancer, and in the future, other difficult-to-treat diseases. Our pipeline includes HyperAcute™ immunotherapies that stimulate the immune system to target and destroy cancer cells,1 as well as Indoleamine 2,3-dioxygenase (IDO) pathway inhibitors that suppress the mechanisms by which tumors evade immune-mediated destruction.1

Our lead HyperAcute™ immunotherapy product candidate, algenpantucel-L, is being studied under Fast Track and Orphan Drug designations in a phase 3 registration trial for patients with surgically-resected pancreatic cancer. Initiated in May 2010, enrollment of 722 patients across 70 centers was completed in September 2013.2,3 A second phase 3 trial of algenpantucel-L for locally advanced unresectable pancreatic cancer2,3 is currently enrolling patients.4 The second HyperAcute™ immunotherapy candidate in development, tergenpumatucel-L, is being compared to docetaxel in a randomized phase 2B/3 study of progressive or relapsed patients with non-small cell lung cancer.5 Additional HyperAcute™ immunotherapies are in development for various cancers, including melanoma, prostate cancer, and renal cancer.6,7 Unlike other immunotherapy products, HyperAcute™ immunotherapies are derived from allogeneic
(non-patient-specific) previously established cell lines,1,8 enabling a straightforward, efficient, and scalable manufacturing process.1

Our lead IDO pathway inhibitor, indoximod, is a novel immune checkpoint inhibitor that approaches cancer from a different direction, blocking tumor immunosuppression.1 An orally available small molecule,1,9,10 indoximod is being investigated as part of various combination regimens in metastatic breast cancer, and metastatic prostate cancer.11,12