NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1 Study of NT-I7 (efineptakin alfa) for the Treatment of Kaposi Sarcoma in Patients With or Without HIV Infection
July 26, 2021 at 04:30 pm IST
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NeoImmuneTech, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1 study evaluating the company’s lead asset, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), for the treatment of Kaposi Sarcoma in patients with or without infection with HIV. This investigator-initiated trial will be conducted by the Cancer Immunotherapy Trials Network (CITN), a program funded by the National Cancer Institute, part of the National Institutes of Health, that is managed by Fred Hutchinson Cancer Research Center in its role as the CITN Central Operations and Statistical Center. Kaposi Sarcoma (KS) is an angioproliferative tumor associated with infection by Kaposi sarcoma-associated herpes virus (KSHV). The identification of a viral etiology of KS helped explain the long-observed association between KS and immunosuppression, specifically CD4+ T cell lymphopenia, commonly seen with HIV infection. IL-7 plays an important role in T cell development and proliferation. In chronic uncontrolled HIV infection, physiologic doses of IL-7 are unable to prevent CD4+ lymphopenia. Furthermore, lymphopenia-inducing insults that may occur in the treatment of KS with anti-neoplastic or radiation treatment could result in a prolonged CD4+ T cell depletion. HIV-related KS accounts for greater than 80% of KS in the United States and increases the risk of death by at least two-fold in these patients.
NeoImmuneTech, Inc. is a clinical-stage T cell-focused biopharmaceutical company. The Company is engaged in the discovery and development of immuno-therapeutics. Its lead asset includes NT-I7 (efineptakin alfa), which is a T Cell Amplifier. NT-I7 is a human IL-7 (Interleukin-7) fusion protein that overcomes the limitations of endogenous IL-7. The IL-7 domain promotes T cell development, which plays a role in the immune response. The N-terminus of the IL-7 domain overcomes its structural instability and enables mass production of NT-I7. NT-I7 is a clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications. It is conducting multiple clinical trials of NT-I7 in multiple indications both as a monotherapy and in combination with other therapeutics, such as checkpoint inhibitors and other. Its products include NIT-106, NIT-109, NIT-110, NIT-119, NIT-120, NIT-104, NIT-107, NIT-112, NIT-105, NIT-108, NIT-113, NIT-114, NIT-115, NIT-116 and NIT-A01.
NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1 Study of NT-I7 (efineptakin alfa) for the Treatment of Kaposi Sarcoma in Patients With or Without HIV Infection