NeoImmuneTech to partner with US NIAID, NIH

NeoImmuneTech, Inc., 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 feasible.

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) 68th Annual Meeting (October 16-19, 2022).
MB Bureau