FDA grants orphan drug designation to Aduro's CRS-207 for treatment of pancreatic cancer

Aduro BioTech, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation for CRS-207, a novel immunotherapy, for the treatment of pancreatic cancer. The FDA had previously granted the same designation for the company's GVAX Pancreas, another cancer immunotherapy that is being evaluated in combination with CRS-207. Orphan designation qualifies Aduro for seven years of marketing exclusivity in the U.S. if the company is the first to obtain marketing approval for the immunotherapies in pancreatic cancer and also qualifies the company for certain tax credits and waivers for prescription drug user fees.

"We are excited to have orphan drug designations for both of our pancreatic cancer immunotherapies, which will support development of these products," said Dirk Brockstedt, Ph.D., senior vice president of research and development at Aduro. "We have been evaluating the potential synergy of sequential administration of GVAX Pancreas followed by CRS-207 as a treatment for metastatic pancreatic cancer and have recently completed a randomized, controlled Phase 2 study."

CRS-207 is a live-attenuated Listeria monocytogenes strain that has been genetically engineered to be safe for clinical use and to induce a potent immune response specific for the tumor-associated antigen mesothelin. GVAX Pancreas, which was recently acquired by Aduro, consists of two irradiated, human pancreatic cancer cell lines that have been genetically modified to secrete the immune-stimulatory cytokine GM-CSF.

The American Cancer Society estimates that approximately 45,000 people will be diagnosed with pancreatic cancer and approximately 38,000 will die of the disease in the U.S. in 2013. Most patients are not diagnosed until the cancer has metastasized, at which point the observed 5-year survival is only 2%.