On January 30, 2024 NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, reported that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer (Press release, NeoImmuneTech, JAN 30, 2024, View Source [SID1234639723]).
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Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a "silent killer" because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.2
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."
NT-I7 has been studied in several robust 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.[5]
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 US. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent.
About Pancreatic Cancer
Pancreatic cancer is a malignant, aggressive tumor of the pancreas. More than 90% of cases develop in the exocrine tissue of the pancreas, which makes enzymes to digest food. The less common endocrine tumors, commonly referred to as pancreatic neuroendocrine tumors (NETs), develop in hormone-producing cells.[1} Whilst pancreatic cancer’s low prevalence rate qualifies it as a rare cancer, the aggressiveness of the disease and its high death rate means that patients diagnosed have a very poor prognosis. Every year, 157,107 new patients are diagnosed with pancreatic cancer in the US and Europe Union combined. [1],[4]
About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.