NewLink Genetics to Present Phase 2 Data of Its HyperAcute® Pancreas Immunotherapy at ASCO 2011 Gastrointestinal Cancers Symposium

AMES, Iowa, Jan. 21, 2011 /PRNewswire/ -- NewLink Genetics Corporation today announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California. A summary of the poster is below.

Title: Effect of the addition of algenpantucel-L immunotherapy to standard adjuvant therapy on survival in patients with resected pancreas cancer

  • General Poster Session B, Friday January 21, 2011, 11:45 AM - 1:15 PM Pacific Time

  • Abstract # 236, (poster board A85)

  • First Author: Dr. Jeffrey M. Hardacre, University Hospitals Case Medical Center, Cleveland, Ohio

The open-label, non randomized, multicenter Phase 2 clinical trial included 70 patients with surgically resectable pancreatic cancer who received the HyperAcute Pancreas immunotherapy in combination with standard adjuvant chemotherapy. The primary objective of the study was disease-free survival at 12 months.

Based on positive data from this Phase 2 clinical trial, NewLink is currently enrolling a nationwide Phase 3 clinical trial of HyperAcute Pancreas cancer immunotherapy in patients who have successfully undergone pancreatic surgical resection. The U.S. Food and Drug Administration (FDA) has granted both Fast Track designation and Orphan Drug designation for this program.

About HyperAcute Immunotherapy

NewLink's HyperAcute immunotherapy technology is designed to stimulate the human immune system by exploiting a natural barrier present in humans that protects against infection being transmitted from other mammals. This barrier is related to the enzyme, alpha (1,3) galactosyl transferase, or α-GT, which is expressed in the cells of lower mammals but not present in human or other Old World primate cells. The presence of this enzyme results in the expression of a non-human form of carbohydrate called alpha (1,3) galactosyl carbohydrates, or α-Gal, on the surface of affected cells. Introducing α-Gal expressing cells to the human or primate immune system activates an immune response from antibodies against α-Gal. Antibodies directed against the α-Gal epitope are potentially the most abundant natural antibody in humans and represent approximately 1% of circulating human antibodies.

NewLink's HyperAcute cancer immunotherapy product candidates are composed of irradiated, live, allogeneic human cancer cells modified to express the gene that makes α-Gal epitopes. This exposure to α-Gal stimulates the human immune system to attack and destroy the immunotherapy cells on which α-Gal is present by activating complement, an important component of the immune system that is capable of cell destruction. After destruction, NewLink believes the resulting cellular fragments bound by anti-α-Gal antibodies are processed by the immune system to elicit an enhanced multifaceted immune response to tumorassociated antigens common to both the immunotherapy and the patient's tumor cells.

About HyperAcute Pancreas Immunotherapy

NewLink's HyperAcute Pancreas investigational product consists of equal doses of two separate allogeneic pancreatic cancer cell lines engineered to express α-Gal. Although cells making up naturally occurring pancreatic tumors in patients do not express α-Gal, the tumor cells share other molecules, called tumorspecific or tumorassociated antigens, with the genetically altered pancreatic cancer cells contained in HyperAcute Pancreas. NewLink believes the molecules that are common to a patient's tumor cells and HyperAcute Pancreas immunotherapy cells allow the antibodies and immune cells that develop against the HyperAcute Pancreas immunotherapy cells to target and destroy the patient's own tumor cells as well.

About Pancreatic Cancer

The American Cancer Society has estimated that approximately 43,000 new cases of pancreatic cancer will be diagnosed in the United States in 2010. Pancreatic cancer has generally been recognized as an aggressive form of cancer with non-specific initial symptoms, making it difficult to diagnose at an early stage. Due to the difficulty in diagnosis and the aggressive nature of this cancer, a 96% mortality rate is associated with this disease, with one-year and five-year overall survival rates of about 24% and 5%, respectively. HyperAcute Pancreas initially targets patients with localized tumors that can be removed surgically, or resected. Approximately 20% of patients in the United States are eligible for resection at initial diagnosis. These earlier stage, resected patients have significantly better prognoses than patients with laterstage disease since they tend to have better nutritional and immune status and significantly lower amounts of micrometastatic and residual disease. Resection followed by chemotherapy or chemoradiotherapy, known as adjuvant therapy, extends median survival to approximately 18 months. NewLink believes the addition of HyperAcute Pancreas to adjuvant standardofcare has the potential to improve median disease-free survival and overall survival in resected pancreatic cancer patients.

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. NewLink's portfolio includes biologic and smallmolecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed with an objective to harness multiple components of the innate immune system to combat cancer, either as a monotherapy or in combination with current treatment regimens, without incremental toxicity. NewLink's lead product candidate, HyperAcute Pancreas cancer immunotherapy is being studied in a Phase 3 clinical trial in surgicallyresected pancreatic cancer patients.  This clinical trial is being performed under a Special Protocol Assessment with the U.S. Food and Drug Administration.  NewLink and its collaborators have completed patient enrollment for a Phase 1/2 clinical trial evaluating its HyperAcute Lung cancer immunotherapy product candidate for non-small cell lung cancer and a Phase 2 clinical trial for its HyperAcute Melanoma cancer immunotherapy product candidate.  NewLink is also developing d-1-methyltryptophan, or D-1MT, a smallmolecule, orally bioavailable product candidate from NewLink's proprietary indoleamine(2, 3)dioxygenase, or IDO, pathway inhibitor technology.  Through NewLink's collaboration with the National Cancer Institute, NewLink is studying D-1MT in various chemotherapy and immunotherapy combinations in two Phase 1B/2 safety and efficacy clinical trials.  For more information please visit us at www.linkp.com.

SOURCE NewLink Genetics Corporation



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