NeoImmuneTech to Partner with U.S. National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) for Drug Development in Acute Radiation Syndrome (ARS)

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Jan 03, 2023, 05:09 ET

ROCKVILLE, Md., Jan. 3, 2023 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to develop NeoImmuneTech's main asset NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of Acute Radiation Syndrome (ARS).

ARS is an acute illness caused by irradiation of most of the body by a high dose of penetrating radiation in a short period of time. These kinds of exposures can cause profound suppression of hematopoiesis and T cell depletion, significantly increasing susceptibility to infections. Currently, there is no therapeutic option for accelerating recovery of the T cell compartment following radiation exposure. NT–I7, a novel long-acting human interleukin-7 (IL-7), is expected to quickly restore lymphocyte levels and reduce vulnerability to infectious disease after radiation exposure. In the clinical setting, NT–I7 has been shown to increase T cell counts significantly and persistently while being safe and well tolerated.

NeoImmuneTech and NIAID will collaborate to design a study plan to test NT-I7 in NIAID's established ARS rodent models. NIAID will conduct the study with NIT-provided NT-I7. The data generated will greatly aid in the development of NT-I7 as a medical countermeasure (MCM) for ARS. If the study confirms NT-I7's efficacy in rodents, additional studies could be undertaken to confirm NT-I7's efficacy in nonhuman primates. With these preclinical studies, NIT would seek U.S. Food and Drug Administration (FDA) approval for NT-I7 for the treatment of ARS under the "Animal Rule", which is an approval pathway used for MCM development when human efficacy studies are not ethical or feasible¹.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc., said: "The further we study the scientific and clinical potential of NT-I7, the more opportunities we identify. Our partnership with NIAID is a significant step forward in the development of our novel drug compound that is already being studied in phase 1 and 2 clinical trials in multiple oncology and infectious disease indications as a monotherapy, as well as in combination with checkpoint inhibitors (CPIs) and Chimeric antigen receptor (CAR) T-cell therapy."

With the support of NIT, initial preclinical studies conducted by Dr. Benny Chen at Duke University demonstrate that NT-I7 improves T cell reconstitution following total body irradiation. These results were presented at the 2022 Radiation Injury Treatment Network (RITN) Workshop (August 4-5, 2022) and at the Radiation Research Society (RRS) 68^th Annual Meeting (October 16-19, 2022).²

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 1986.³

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 naïve 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.

¹Animal Rule (21 CFR 314.600-650 for drugs; 21 CFR 601.90-95 for biologics; effective July 1, 2002) allow for the approval of drugs and licensure of biological products when human efficacy studies are not ethical and field trials to study the effectiveness of drugs or biological products are not feasible.
² Abstracts: Yujing Zou, Yiqun Jiao, Alexandra A. Wolfarth, Sara FerrandoMartinez, Byung Ha Lee, and Benny J. Chen, "NT-I7, a long-acting recombinant human interleukin-7, enhances T cell reconstitution following total body irradiation". Radiation Injury Treatment Network (RITN) 2022 Workshop. Presented August 4, 2022.
Yujing Zou, Yiqun Jiao, Alexandra A. Wolfarth, Sara FerrandoMartinez, Byung Ha Lee, and Benny J. Chen, "NT-I7, a long-acting recombinant human interleukin-7, enhances T cell reconstitution following total body irradiation". Radiation Research Society (RRS) 68th Annual International Meeting. Presented October 16-19, 2022.
³ https://www.cdc.gov/nceh/radiation/emergencies/arsphysicianfactsheet.htm