NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced that the first patient has been dosed in the pilot study evaluating NT-I7 (efineptakin alfa), a novel long-acting human IL-7, in progressive multifocal leukoencephalopathy (PML), a rare but very aggressive, opportunistic brain infection. PML is caused by the reactivation of John Cunningham virus (JCV) in immunocompromised individuals, and there are currently no approved therapies for this illness. This investigator-initiated study is being led by Irene Cortese, M.D., of the National Institute of Neurological Disorders and Stroke (NINDS)/National Institute of Health (NIH).
“PML is a rare but devastating disease with no approved therapeutic options,” said Dr. Cortese. “By increasing the number and functionality of patients’ lymphocytes, which are critical for fighting infections, NT-I7 may hold promise to improve PML outcomes.”
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.
“We are pleased to have dosed the first patient in this pilot study and evaluate NT-I7 as a potential new treatment for PML,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “Because PML tends to affect immunocompromised individuals, NT-I7 is an ideal candidate to bolster patients’ immune response and help individuals with PML to successfully overcome this rare but devastating infection.”
The primary outcome measure of this pilot study is longitudinal change in absolute lymphocyte count following NT-I7 administration. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT04781309.
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 enhanced 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). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. 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.
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