FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech's NT-I7 for Advanced Pancreatic Cancer Treatment

• Pancreatic cancer has the highest mortality rate of all major cancers with only a 3% relative-survival-rate at 5-years for the advanced form. ^{[1], [2]}
• Pancreatic tumors are highly resistant to chemotherapy and radiation and there are limited treatment options^[2]
• FDA ODD designation bolsters NeoImmuneTech's determination to accelerate the clinical development of NT-I7 as a potential new therapy for this difficult-to-treat 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
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.

About NeoImmuneTech, Inc.
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

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
[2] UEG Public Affaires 'Pancreatic Cancer Across Europe – Taking a United Stand' https://ueg.eu/files/771/b7ee6f5f9aa5cd17ca1aea43ce848496.pdf Last accessed: March 2022
[3] FDA letter
[4] European Commission . (2018). European Cancer Information System. https://ecis.jrc.ec.europa.eu/ Last accessed: March 2022
[5] Naing A, Kim R, Barve M, et al408 Preliminary biomarker and clinical ata of a phase 2a study of NT-I7, a long-acting interleukin-7, plus pembrolizumab: cohort of subjects with checkpoint inhibitor-naïve advanced pancreatic cancer Journal for ImmunoTherapy of Cancer 2021;9:

SOURCE The NeoImmuneTech, Inc