FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech's NT-I7 for the treatment of Glioblastoma Multiforme

• Glioblastoma multiforme is one of the most complex, deadly and treatment-resistant cancer with a 5-year survival rate of 6.8% and an average length of survival of only 8 months [1]
• 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, July 13, 2022 /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 for the treatment of Glioblastoma Multiforme.

Despite decades of research, GBM remains one of the deadliest and hardest-to-treat cancers. More than 13,000 Americans are expected to be diagnosed with GBM in 2022.¹ Standard treatments using surgery, radiation, TMZ and TTFs have failed to date to greatly improve survival, and there is no standard treatment for recurrence, which is inevitable. Also, among the multiple factors impacting the survival of GBM patients, the current treatment options expose patients to a severe and prolonged systemic lymphopenic state known as "treatment-related lymphopenia" (TRL). TRL is associated with shorter survival both in GBM and other solid tumors. With its potential to restore lymphocyte levels and subsequently reverse systemic lymphopenia, NT-I7 may offer promising ways to effectively treat GBM, if confirmed by its development program.

Dr Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "We are excited that the FDA granted NT–I7 an ODD in the treatment of glioblastoma multiforme. This decision adds further credibility to our existing clinical evidence that NT-I7 has the potential to bring a new essential therapy option to people with advanced/metastatic GBM who have undergone prior chemo-radiation therapy. We look forward to continuing our collaboration with FDA, as we explore the benefits of NT-I7 in treating people with GBM in combination with other anti-cancer treatments, including immunotherapies".

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 prolong the anti-tumor response in people with GBM and other solid tumors.^[2] Current studies in GBM include study NIT-107 in newly diagnosed GBM patients and study NIT-120 in recurrent GBM patients. Preliminary data from study NIT-107 presented at Society for Immunotherapy of Cancer Annual Meeting (SITC), in November 2021, showed favorable trends of progression free survival (PFS) and overall survival (OS) in NT-I7 treated high-grade gliomas (HGG) patients after chemoradiotherapy.[3]

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 (FDA filing fee waive, guaranteed sales period after approval, etc).

About Glioblastoma Multiforme

Glioblastoma multiforme, also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor, which accounts for 49.1% of all primary malignant brain tumors.

Each year, an estimate of more than 10,000 individuals in the United States succumb to GBM. Due to its characteristics of being difficult to treat and treatment-resistant cancer, the survival rates and mortality statistics or GBM have been virtually unchanged for decades. In addition to being life-threatening, the treatment is known to be harsh, inflicting devastating results to the brain, which controls cognition, mood, behavior and every function of every organ and body parts. It leaves many patients with inability to work, drive and host of other functions that contribute to one's sense of self and independence.¹

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] National Brain Tumor Society 'Glioblastoma Facts and Figures' About GBM - GBM Awareness Day | National Brain Tumor Society Last accessed: June 2022

[2] Naing A, Kim R, Barve M, et all. Preliminary biomarker and clinical data 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:

[3] Zhou, Alice, et al. NT-I7, a long-acting interleukin-7, promotes expansion of CD8 T cells and NK cells and immune activation in patients with newly diagnosed high-grade gliomas after chemoradiation. J Immunother Cancer 2021;9(Suppl 2):A428

SOURCE The NeoImmuneTech, Inc