15 July 2020 - - The US Food and Drug Administration has cleared US-based clinical-stage T cell-focused biopharmaceutical company NeoImmuneTech, Inc's Investigational New Drug application to study the use of NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment of adults with mild COVID-19, the company said.

The company-sponsored Phase 1 trial is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the University of Nebraska Medical Center.

IL-7 is a fundamental cytokine for naïve and memory lymphocyte development and has been shown to enhance anti-viral T cell response, limit T cell exhaustion and apoptosis, and ameliorate immunosenescence by expanding the T cell receptor repertoire.

NT-I7, the only clinical-stage long-acting IL-7, has demonstrated in clinical trials to have the ability to restore lymphocyte count and exhibit a well-tolerated safety profile.

This Phase 1 clinical trial of NT-I7 is a multi-center, double-blind, randomized, placebo-controlled study that will evaluate the safety and efficacy of NT-I7 in adult patients with mild COVID-19.

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit.

IL-7 is a fundamental cytokine for naïve and memory T cell development and for 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.

NeoImmuneTech 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).

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.