NewLink Genetics receives FDA SPA approval for HyperAcute immunotherapy Phase 3 pancreatic cancer trial

Feb 12 2010

NewLink Genetics Corporation announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for a pivotal Phase 3 trial of its HyperAcute immunotherapy in pancreatic cancer. Pancreatic cancer is highly lethal and is currently an area of very significant unmet medical need.  The SPA is a written agreement between NewLink as the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of a Phase 3 trial to be used in support of a Biologic License Application (BLA).

"NewLink has a broad platform of tumor specific immunotherapies based on its HyperAcute technology platform.  With the approval of this Special Protocol Assesment, we will be advancing the first of these into pivotal studies," said Dr. Charles Link, Chairman and Chief Executive Officer of NewLink Genetics Corporation.  "With the additional funding we raised in 2009, we are well positioned to launch the Phase 3 trial under this protocol in more than 50 major cancer centers."