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 its investigational new drug (IND) application for a pilot study evaluating the company’s lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in progressive multifocal leukoencephalopathy (PML). PML is a rare, aggressive, opportunistic brain infection caused by the reactivation of John Cunningham virus (JCV) in immunocompromised individuals. The investigator-initiated study will be led by Irene Cortese, M.D., of the National Institute of Neurological Disorders and Stroke (NINDS)/National Institute of Health (NIH).
“With no anti-viral therapies available to treat PML, the only possibility for survival is to restore the antiviral immune response,” said Dr. Cortese. “Unfortunately for many people who develop PML this is not easily achieved – and this is why we have strong interest in strategies that can facilitate and effectively speed up immune reconstitution, such as NT-I7.”
PML is characterized by progressive damage of the white matter of the brain at multiple locations resulting from lytic infection of glia cells, leading to permanent damage of the affected nervous system, and in some cases can be fatal. Common conditions predisposing PML are hematologic and solid malignancies, rheumatologic disorders, primary immune deficiencies, and HIV infection. Currently, there is no specific prophylaxis for PML and no effective anti-JCV treatment.
“Following NT-I7’s FDA Orphan Drug Designation for the treatment of PML in June 2020, this IND clearance is an important step in developing a new treatment option for PML, a serious and potentially fatal infection of the brain,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “PML chiefly affects immunocompromised individuals. We believe that NT-I7’s ability to amplify T cells as well as increase their functionality could enhance the recovery of the immune system, bolster the immune response in PML patients, and thereby provide assistance to patients in fighting this devastating disease.”
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.