Quarterly update



Key Highlights – January to End of March

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

- First patient dosed (FPD) in the phase II study NIT-120, in recurrent glioblastoma (GBM)

- Discontinuation of NIT-116, a clinical trial conducted in the United States for COVID-19 patients

Considering 2023 development perspectives for NT-I7, Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc., said: “Our long-acting human IL-7 is in full clinical development in multiple phase I and phase II trials. In 2023, NIT aims to progress this unique program, potentially with a few adjustments where needed, to continue to follow the science and gather stronger clinical data”.


On January 3, NeoImmuneTech and NIAID announced their collaboration to design a study plan to test NT-I7 in NIAID’s established Acute Radiation Syndrome (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 non-human 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 feasible.


On February 7, NIT announced the First Patient Dosed (FPD) in the phase II study NIT-120, which is investigating the combination of NT-I7 and pembrolizumab for the treatment of recurrent glioblastoma (GBM). The goal of NIT-120 is to evaluate the safety and effectiveness of NT-I7 and pembrolizumab, as well as the overall survival in patients with recurrent GBM. The study has been initiated following impressive results from the NIT-107 phase I clinical trial in newly diagnosed GBM patients.


On March 10,  NIT announced its decision to discontinue NIT-116, a clinical trial conducted in the United States for patients with mild COVID-19 symptoms. The decision was based on the low business value for investment resulting from recent changes in the COVID-19 treatment environment. Given the current state of vaccine development and distribution in the United States, as well as the mildness of most COVID-19 symptoms, it has become increasingly difficult to distinguish between COVID-19 and other common illnesses such as influenza. As a result, patient enrollment for this clinical trial had significantly decreased.


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