ROCKVILLE, Md.--(BUSINESS WIRE)--NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the second study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment of COVID-19. 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.
“Treatments that harness and enhance the immune system, helping it fight diseases such as cancer and infectious diseases, hold promise in treating a viral infection such as COVID-19, where the immune system is extremely burdened and exhausted,” said Dr. Campian. “As a T-cell amplifier, NT-I7 is designed to boost the adaptive immune response, which is crucial for the clearance of the virus in COVID-19. I look forward to evaluating this therapeutic candidate in patients with COVID-19.”
“Continuing on our mission to improve patient lives, NeoImmuneTech is very pleased to have received FDA clearance to begin a second trial studying NT-I7 as a potential immune enhancer for adult COVID-19 patients. The two trials will complement each other and speed up enrollment as well as increase the number of patients,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “Since lymphopenia is a hallmark of COVID-19, patients with weakened immune systems are at particularly high risk for a serious infection of COVID-19, and subsequently have unfavorable clinical outcomes, including death. NeoImmuneTech hopes that NT-I7 could help to prevent the progression to severe COVID-19 and ultimately improve clinical outcomes for patients affected by this pandemic.”
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.