NeoImmuneTech, Inc., a T cell-focused therapeutics company, was granted Orphan Drug Designation (ODD) from the U.S. FDA for NT-I7 (efineptakin alfa) (rhIL-7-hyFc) for the treatment of pancreatic cancer.
 
NT-I7 has been studied in several phase I and II clinical trials and has demonstrated the potential to amplify T cells across the subsets, boost the immune system, and enhance the anti-tumor response in people with pancreatic cancer and other solid tumors.
 
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent.
 
Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the U.S. and EU with a combined annual mortality of 139,000. Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. 
 
Dr. Luke Oh, Ph.D., President of NeoImmuneTech, Inc. said, “We are excited that the FDA granted NT-I7 an ODD in the treatment of pancreatic cancer. This decision adds further credibility to our existing evidence that NT-I7 has the potential to bring a much-needed therapy option to people suffering from pancreatic cancer. We look forward to continuing our collaboration with FDA, as we explore the therapeutic benefits of combining NT-I7 with other anti-cancer treatments such as immunotherapies for patients with pancreatic cancer.”