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NeoImmuneTech receives US FDA approval to begin phase 1 study of NT-I7 to treat Kaposi Sarcoma in patients with or without HIV infection

Rockville, Maryland
Wednesday, July 28, 2021, 18:00 Hrs  [IST]

NeoImmuneTech, a clinical-stage T cell-focused biopharmaceutical company, announced that the US 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.

“Our unique long-acting human IL-7, efineptakin alpha, has demonstrated its ability to markedly increase the number of functional T cells in both lymphopenic and non-lymphopenic patients, and exhibited a favorable safety profile,” said NgocDiep Le, M.D., Ph.D., executive vice president and chief medical officer of NeoImmuneTech. “We believe that NT-I7 will be well-tolerated in KS patients with or without HIV infection, has the potential to revert lymphopenia, and could be an indispensable tool to improve outcomes for these patients.”

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.


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