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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