This investigator-initiated trial will be conducted by the Cancer Immunotherapy Trials Network, 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 is an angioproliferative tumor associated with infection by Kaposi sarcoma-associated herpes virus.
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.
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. 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).
Poolbeg PHarma plc receives notice of allowance for POLB 001 patent
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
Micron Biomedical names new scientific advisor to CEO
Quanterix partners with leading health networks for Alzheimer's diagnosis advancements
Precision BioSciences reports FDA pre-IND feedback for PBGENE-HBV
VBI to sell manufacturing capabilities and enter new license agreement with Brii Biosciences
Ondine Biomedical's Steriwave shows promise in nasal pathogen reduction
BioSenic expands patent coverage for ATO therapeutic platform
PacBio unveils Nanobind PanDNA kit for enhanced DNA extraction solutions
Sequentify receives funding from Israel Innovation Authority
INOVIO plans BLA submission for INO-3107 as RRP treatment
ImmunityBio secures USD320m investment from Oberland Capital
Poolbeg Pharma prioritises promising RSV drug candidates identified through AI-led analysis
GHIT fund invests JPY500m in antimalarial drug clinical trial