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

AMES, Iowa, May 27 /PRNewswire/ -- NewLink Genetics Corporation announced today treatment of the first patient in a nationwide Phase 3 clinical trial of its HyperAcute®-Pancreas cancer immunotherapy for patients who have successfully undergone pancreatic surgical resection.

"This pivotal study represents one of the largest Phase 3 clinical trials of immunotherapy ever conducted for pancreatic cancer in the United States," said Charles Link, M.D., chairman and chief executive officer of NewLink Genetics Corporation. "Our HyperAcute-Pancreas immunotherapy is unique from other approaches in that it is designed to trigger a powerful immune response to cancer cells similar to the hyperacute reactions that occur following xenotransplants – when tissues from lower animals are transplanted into humans."

The study will enroll approximately 700 previously untreated patients with Stage I or II surgically-resected cancer of the pancreas who have no visible disease detectable by a CT scan. Patients will be randomly assigned to receive the current standard of care, either Gemcitabine alone or Gemcitabine +5-FU and radiation with or without HyperAcute-Pancreas immunotherapy at about 50 major medical centers. Patients will be treated with adjuvant therapy for approximately six months and followed with periodic imaging for recurrence for five years. The primary objective is overall survival and secondary endpoints include disease-free survival, safety/toxicity and immunological responses.

"Patients with pancreatic cancer have very limited treatment options and a poor prognosis," said William Hawkins, M.D., associate professor, Hepatobiliary, Pancreatic and Gastrointestinal Surgery, Washington 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 introduced into the human body. The response is strong enough to destroy transplanted cells and tissues within hours. NewLink's HyperAcute immunotherapy exploits this hyperacute antigen-antibody response to educate a patient's immune system to attack and destroy the patient's own unmodified cancer cells.

The company's HyperAcute products are composed of irradiated, allogeneic (off the shelf), whole cancer cells that have been genetically modified to add alpha-Gal residues to cell-surface lipids and proteins. The alpha-Gal epitopes function as a molecular adjuvant, effectively harnessing the xenotransplant rejection mechanism.

About HyperAcute-Pancreas Immunotherapy

HyperAcute-Pancreas immunotherapy consists of two equal cell doses of allogeneic pancreatic cancer cell lines engineered to express the murine alpha-Gal gene. Although cells making up naturally occurring pancreatic tumors in patients do not express alpha-Gal, they share other molecules including new tumor-specific and tumor -associated antigens, with the genetically altered pancreatic cancer cells introduced by the immunotherapy. Those similarities are believed to allow the antibodies and immune cells targeting alpha-Gal to redirect their attack and destroy patient's own tumor cells.

About Pancreatic Cancer

Cancer of the pancreas is the fourth leading cause of cancer death in the United States, killing more than 35,000 Americans in 2009. The disease is divided into two broad subtypes based on histological classification: pancreatic endocrine tumors are diagnosed in 5 percent of cases, and pancreatic adenocarcinoma accounts for the remaining 95 percent. Incidence and age-adjusted mortality rates of pancreatic adenocarcinoma are nearly equal, meaning the disease is almost universally fatal. Pancreatic cancer is characteristically aggressive with non-specific initial symptoms, making it difficult to diagnose early. Conventional therapies have little impact on prognosis and disease outcome.

Surgical resection of the tumor is currently the only chance for a cure. Without resection, overall median survival is four to six months with an estimated five-year survival rate of 0.4 percent to 5 percent. Resection increases median survival to 13 to 15 months with five-year survival of about 10 percent, which may be extended to 20 months and 24 to 30 percent, respectively, with adjuvant chemotherapy. Unfortunately, only 10 to 15 percent of patients are deemed candidates for resection given the stage of their disease by the time they are diagnosed.

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company applying innovative technologies to create new therapeutic agents for patients with cancer and infectious diseases. Its products are designed to enhance the patient's immune system, enabling the body's immune cells to target pathogens and diseased tissues. For more information please visit us at www.newlinkgenetics.com.


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