NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced 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.
ROCKVILLE, Md. , Jan. 30, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced 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.[3] 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 About NT-I7 (efineptakin alfa) (rhIL-7-hyFc) About NeoImmuneTech, Inc. Forward-looking Statements The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the “Company”) that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company’s control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein. Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties, and is subject to change based on various factors. [1] American Cancer Society ‘Cancer Facts and Figures 2022' https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf Last accessed: March 2022
SOURCE The NeoImmuneTech, Inc |
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