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.