27 July 2020 - - US-based clinical-stage T cell-focused biopharmaceutical company NeoImmuneTech, Inc has received a study-may-proceed letter from the US Food and Drug Administration for the second study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment of COVID-19, the company said.

The investigator-initiated Phase 1 trial is being conducted by Jian Li Campian, M.D., Ph.D. of Washington University School of Medicine, St. Louis.

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

IL-7 is an important growth factor for the immune system, the release of which induces the development, proliferation, and persistence of naïve and memory T cells.

IL-7 has been shown to restore lymphocyte count, enhance anti-viral T cell response, reduce T cell exhaustion and death, and thereby potentially improve clinical outcomes in patients with COVID-19, where low lymphocyte count strongly correlates with poor prognosis.

NT-I7 is the only clinical-stage long-acting IL-7, and has demonstrated in multiple clinical trials to restore lymphocyte count, including naïve and memory T cells, and exhibits a well-tolerated safety profile.

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) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC.

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.