NeoImmuneTech Announces Clearance for Investigational New Drug Application of NT-I7 (efineptakin alfa) in Adults with Mild COVID-19
Trial to be Conducted in Collaboration with NIH and University of Nebraska Medical Center
ROCKVILLE, Md.--(BUSINESS WIRE)-- NEOIMMUNETECH, INC, a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) 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-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 (NIH), and the University of Nebraska Medical Center (UNMC).
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.
“We’re very pleased to collaborate with NIAID and the University of Nebraska Medical Center, two world-leading institutions in developing and establishing standard anti-viral treatments,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech (NIT). “Lymphocytes play a crucial role in fighting various infections. In COVID-19, there is a clear correlation of lymphopenia and impaired adaptive immune response with poor clinical outcomes. By reversing lymphopenia and restoring the patients’ adaptive immune responses, NT-I7 has the potential to help patients achieve better clinical outcomes.”
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.
“The University of Nebraska Medical Center is a leader in advancing the understanding of COVID-19 and we are delighted to partner with NIAID and NIT to develop NT-I7 as a potential new treatment option for our COVID-19 patients,” commented Andre Kalil, M.D., M.P.H., Department of Internal Medicine, Division of Infectious Diseases, UNMC. “Our study, called SPESELPIS, which means double hope in Roman and Greek, will establish safety and appropriate dosing of this novel treatment, designed to prevent the progression to severe COVID-19 in those most vulnerable.”
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, Inc. (NIT) 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. For more information, please visit www.neoimmunetech.com.
Shai Biran, Ph.D.