NeoImmuneTech's 'NT-I7', First Step Toward Commercializing Radiation Therapy Agent

NeoImmuneTech announced on the 1st that the non-clinical trial of 'NT-I7 (substance name: Epin?ptakin alfa)' for the treatment of acute radiation syndrome (ARS) in rodents, conducted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), began on the 31st of last month.

Yang Se-hwan, CEO of NeoImmuneTech, is explaining the development of ARS therapeutics at a corporate presentation.
[Photo by Lee Chun-hee]

ARS is a syndrome caused by exposure to a large amount of radiation in a short time, resulting in organ damage and a decrease in neutrophils and lymphocytes, including bone marrow, which increases the risk of death due to infections. NIAID directly supports the research and development of candidate substances by biotech companies to develop treatments for public health emergencies such as ARS. According to NeoImmuneTech, while treatments for neutropenia or thrombocytopenia have already been released or are under development, there are currently no treatments available for lymphopenia.

NeoImmuneTech signed an agreement last December with NIAID, an agency under the U.S. National Institutes of Health (NIH), for the research and development of ARS treatments. Compared to rodents heavily exposed to radiation, whose T cells took three months to recover to normal levels on their own, non-clinical research results with Duke University demonstrated that administration of NT-I7 rapidly restored T cell counts to normal levels within 1 to 2 weeks, proving its effectiveness.

After finalizing related preparations with NIAID, the project has now entered full-scale non-clinical trials. NIAID conducts the research directly and covers all related experimental costs. NeoImmuneTech only needs to provide the new drug candidate NT-I7 to NIAID. If the rodent experiments succeed, primate experiments, including monkeys, will be conducted by the Biomedical Advanced Research and Development Authority (BARDA). Due to the nature of the disease, which requires strong radiation exposure to develop, clinical trials on humans are difficult. Therefore, if this process leads to recognition as a national strategic item by the U.S. federal government, emergency use authorization (EUA) could be granted, potentially generating NeoImmuneTech’s first product sales. Although the stockpiling scale by the U.S. Department of Defense varies by treatment, Amgen’s thrombopoietin receptor agonist 'Nplate' was delivered in October last year with a contract worth $290 million (approximately 383.7 billion KRW).

Lee Byung-ha, Chief Scientific Officer (CSO) of NeoImmuneTech, explained, “Due to the nature of the ARS indication, delivery contracts can be made with just two stages of non-clinical trials in rodents and primates,” adding, “We have held multiple meetings with NIAID and undergone sufficient planning processes.” NeoImmuneTech CEO Yang Se-hwan also stated, “This can be seen as the official start of the commercialization of NT-I7,” and added, “We hope to ultimately deliver it as a U.S. national strategic item and achieve stable and reliable sales.”

This content was produced with the assistance of AI translation services.