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Biopharmaceuticals FDA

 News Release - November 20, 2023

FDA Grants Orphan Drug Designation to NeoImmuneTech's NT-I7 for the Treatment of Acute Radiation Syndrome

The FDA's Orphan Drug Designation is aimed at advancing treatments for rare diseases, including Acute Radiation Syndrome (ARS), which currently has limited treatment options

NeoImmuneTech's NT-I7 has shown potential in nonclinical studies to address the immunosuppressive effects of ARS


ROCKVILLE, Md, Nov. 20, 2023 -- (Healthcare Sales & Marketing Network) -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for their investigational drug NT-I7 (efineptakin alfa) (rhIL-7-hyFc) for the treatment of Acute Radiation Syndrome (ARS).

ARS is an illness that occurs following a high dose of radiation exposure, leading to severe damage to the bone marrow and the immune system. Currently, there are no treatments available that effectively promote T cell recovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), is expected to address this unmet medical need, with the potential to rapidly recover and improve the immune response. In the clinical setting, NT-I7 has demonstrated impressive results by effectively and consistently boosting T cell counts, all while maintaining a remarkable level of safety and tolerance.

The FDA's ODD for NT-I7 reflects progress in the company's efforts. A contract research organization (CRO) under contract to National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is conducting a study that employs well-developed NIAID ARS rodent models to investigate NT-I7's efficacy as a potential treatment for the serious health implications of ARS. NIAID is supporting this research through product development funding to the CRO.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc., said: "Obtaining the Orphan Drug Designation from the FDA is an important acknowledgment of the immense potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS."

ODD is a status assigned to a medicine intended for use against a rare disease or condition that affects fewer than 200,000 people in the United States. The designation provides incentives to advance the development of treatments for rare diseases, including protection from competition once the drug is on the market, tax credits for clinical research costs, and exemption from prescription drug user fees.

About Acute Radiation Syndrome (ARS)

Acute Radiation Syndrome (ARS) is an acute illness caused by irradiation of the entire body by a high dose of penetrating radiation in a very short period of time (typically a matter of minutes or less). Examples of people who suffered from ARS are individuals exposed during the Hiroshima and Nagasaki atomic bombings, and the firefighters that responded after the Chernobyl Nuclear Power Plant incident in 1986.[1]

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)

NT-I7 (efineptakin alfa) (rhIL-7-hyFc) 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 na´ve and memory T cell development and 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 a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech, Inc. (NIT)

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] https://www.cdc.gov/nceh/radiation/emergencies/arsphysicianfactsheet.htm


Source: NeoImmuneTech

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