HyperAcute®-Pancreas
HyperAcute-Pancreas immunotherapy development status & plan
NewLink has successfully completed a Phase 1 study of its HyperAcute-Pancreas cancer immunotherapy, and two ongoing Phase 2 studies have yielded highly encouraging results so far. We are currently finalizing plans for a pivotal trial of HyperAcute-Pancreas immunotherapy in pancreatic adenocarcinoma patients who have successfully undergone surgical resection and emerged with no residual tumor as measured by CT scan. These patients, who generally possess healthy immune systems, are prime candidates for immunotherapy. The pivotal trial will aim to convincingly demonstrate the therapeutic potential of NewLink's HyperAcute cancer immunotherapy platform in an adequately powered and well controlled study including both time to progression and overall survival as endpoints. We plan to initiate this trial in early 2010.
About pancreatic cancer
Cancer of the pancreas is the fourth leading cause of cancer death in the United States. The disease is divided into two broad subtypes based on histological classification: pancreatic endocrine tumors are diagnosed in 5% of cases, and pancreatic adenocarcinoma accounts for the remaining 95%. Incidence and age-adjusted mortality rates of pancreatic adenocarcinoma are nearly equal. In other words, the disease is almost universally fatal. It killed over 35,000 Americans in 2008.
Pancreatic cancer is characteristically aggressive with non-specific initial symptoms, making it difficult to diagnose early. Conventional cancer therapies have little impact on prognosis and disease outcome. Surgical removal ("resection") of the tumor is currently the only chance for a cure.
Without resection, the overall median survival is 4 to 6 months with an estimated 5-year survival rate of 0.4% to 5%. Resection increases median survival to 13-15 months with a 5-year survival rate of approximately 10%, which may be extended to 20 months and 24% to 30%, respectively, with adjuvant chemotherapy. Unfortunately, only 10% to 15% of patients are deemed candidates for resection given the stage of their disease by the time they are diagnosed.