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NewLink Genetics Corporation (NewLink) is a late-stage, biopharmaceutical company focused on discovering, developing, and
commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians.
Our portfolio includes both "off-the-shelf" biologic and small-molecule immunotherapy product candidates intended to address large,
unmet oncology indications, including treatment of pancreatic cancer, non-small cell lung cancer (NSCLC), and melanoma.
We believe our technologies may also be useful in the field of infectious disease.
Our biologic pipeline is based on NewLink's HyperAcute® technology platform,which is designed to harness multiple components of
the innate immune system to combat cancer, either alone or in combination with other treatments, without significant incremental toxicity.
In contrast to autologous therapies, HyperAcute product candidates do not require patients to donate cellular material, which permits an
easier scale-up of the manufacturing process.
To date, HyperAcute product candidates have been administered to about 300 cancer patients and have demonstrated good tolerability and a favorable safety profile.
Our lead HyperAcute immunotherapy product candidate is being studied in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients.
This trial is an open-label, randomized, controlled, multi-center, Phase 3 clinical trial evaluating approximately 700 Stage I and Stage II surgically-resected
pancreatic cancer patients, which is being performed under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA).
We have also received Fast Track and Orphan Drug designations from the FDA for this product candidate for the adjuvant treatment of surgically-resected pancreatic cancer.
First and second interim analyses of data from the Phase 3 trial are expected in late 2012 and 2013, respectively, and complete enrollment is expected in 2013.
Additional HyperAcute product candidates, including both NSCLC and melanoma, are in Phase 2 clinical trials.