ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted the Company’s lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) Orphan Drug designation for the treatment of pancreatic cancer. The Agency also granted Fast Track designation for AM0010 in combination with FOLFOX as a second line therapy in patients with advanced metastatic pancreatic cancer. In an ongoing Phase 1 trial, over 340 patients with advanced solid malignancies have been dosed with AM0010, either as a single agent or in combination with standard-of-care chemotherapy drugs or anti-PD-1 antibodies. ARMO plans to initiate a pivotal Phase 3 trial by the end of 2016, using AM0010 in combination with FOLFOX as a second-line therapy in patients with advanced metastatic pancreatic cancer.
“Orphan Drug and Fast Track designations represent key achievements for ARMO as we execute our plans to advance AM0010 into our first Phase 3 trial,” said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. “Pancreatic cancer is difficult to detect at early stages and has the highest mortality rate of all major cancers. New treatment options, including immune-based approaches, are urgently needed for these patients. AM0010 has been shown to specifically engage the immune system to induce comprehensive T-cellactivation and objective tumor responses in cancer patients with advanced malignancies. We have completed interactions with the FDA to initiate a potentially registration-enabling clinical development plan for AM0010. Our team is committed to our urgent goal of developing a new treatment for patients with advanced metastatic pancreatic cancer.”