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NewLink Initiates Pivotal Phase 3 Clinical Trial of HyperAcute(R)-Pancreas Immunotherapy for Resected Pancreatic Cancer
Date:5/27/2010

ashington University School of Medicine, St. Louis, MO. "This clinical trial offers patients with resectable pancreatic cancer an opportunity to receive a new treatment option aimed at eliminating the cancerous tissue from the body by activating the patient's own immune system to destroy their cancer cells."

NewLink is currently advancing four product candidates in human clinical trials. A Phase1/2 study of HyperAcute-Lung cancer immunotherapy in patients with progressive advanced non-small cell lung cancer was presented at the American Association for Cancer Research Annual Meeting in April. The HyperAcute product for melanoma is showing early promise in a small, investigator-sponsored Phase 2 study. Data from Phase 2 studies of pancreatic cancer and melanoma immunotherapies will be presented in June at the American Society for Clinical Oncology meeting.  Additionally, NewLink is developing additional new tumor specific HyperAcute® immunotherapies. NewLink is also developing a first-in-class, small-molecule inhibitor of the indoleamine 2,3 dioxygenase (IDO) pathway, currently in Phase 1 testing and expected to move into Phase 2 studies later this year.      

About HyperAcute Cancer Immunotherapy

In transplants of human organs such as the kidneys or heart, recipients are at risk of rejecting donor organs because of immune system reactions directed against the foreign tissue. That immune response is dramatically stronger if non-primate organs, for example, pig hearts, are transplanted into primates, largely because lower animals express sugar patterns on their cell surfaces that are not expressed in primates. The sugar epitopes, known as alpha(1,3)-galactosyl, or alpha-Gal residues, are powerful antigens that cause a rapid, hyperacute rejection response whenever foreign tissues bearing it are introduc
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SOURCE NewLink Genetics
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