ImmunityBio publishes data showing potential to reduce HIV load

ImmunityBio announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV. Published in The Journal of Infectious Diseases, researchers at the University of Minnesota Medical School gave six HIV-positive individuals infusions of healthy NK cells from close relatives, along with N-803 to boost NK cell activity. All participants in this Phase 1 study experienced significant reduction in infection levels following treatment with N-803. The approach was well tolerated with no unexpected adverse events. Tim Schacker, senior author of this paper, and colleagues at the University of Minnesota Medical School are planning a follow-on study in additional participants to further investigate these immunotherapies in HIV infected individuals. The cytokine interleukin-15, or IL-15, plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer and T cells. N-803 is a novel investigational IL-15 superagonist complex consisting of an IL-15 mutant bound to an IL-15 receptor alpha/IgG1 Fc fusion protein. Its proposed mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding with generation of memory T-cells while avoiding T-reg stimulation. N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naive NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease. N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.