NewLink's HyperAcute cancer immunotherapies represent a unique approach to cancer therapeutics based on stimulating the same types of immune response that occur during hyperacute rejection of xenotransplants. The company's products are composed of irradiated, allogeneic, whole cancer cells that have been genetically modified to add alpha(1,3)-Galactosyl (alphaGal) residues to cell-surface lipids and proteins. The alphaGal epitopes function as a molecular adjuvant, effectively harnessing the xenotransplant rejection mechanism.
NewLink has completed the Phase 1 portion of a Phase 1/2 study of its HyperAcute Lung cancer immunotherapy to evaluate the product's safety, and is nearing completion of the Phase 2 portion that is evaluating efficacy in advanced-stage patients with unresectable, recurrent, and either treatment-refractory or metastatic NSCLC. Information is available at http://clinicaltrials.gov/ct2/show/NCT00420732. In addition, NewLink has applied its HyperAcute technology platform to create unique immunotherapies for melanoma as well as pancreatic, prostate, breast and cancers. Phase 2 data for the pancreatic cancer and melanoma HyperAcute immunotherapies will be presented at this year's American Society of Clinical Oncology meeting in June. NewLink's most advanced program has begun screening patients for a Phase 3 pancreatic cancer clinical study to be conducted under an approved Special Protocol Assesment. This study will evaluate the current standard of care plus or minus NewLink's HyperAcute pancreatic cancer immunotherapy in approximately 700 patients in about 50 sites in North America.
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.