ImmunityBio Launches Phase 2 Trial of Antiretroviral Therapy to Inhibit HIV Reservoirs

 Phase 2 Study Sponsored by U.S. Military HIV Research Program, Thai Red Cross AIDS Research Centre

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research has launched a Phase 2 clinical trial in Thailand to evaluate ImmunityBio’s interleukin-15 (IL-15) superagonist Anktiva® (also called N-803) administered in combination with antiretroviral therapy (ART) during acute HIV infection as an experimental therapy to target and inhibit early establishment of HIV ‘reservoirs’ in infected individuals. Researchers will compare levels of HIV RNA and DNA in lymph node samples pre- and post-treatment and evaluate the therapy’s effects on CD8+ T and natural killer (NK) immune cells. The study is being conducted at the Thai Red Cross AIDS Research Centre in Bangkok.

The trial’s participants are being recruited through MHRP’s acute HIV infection cohort, which identifies individuals in the earliest post-infection stages. The cohort serves as a foundation to help researchers conduct investigations into long-term remission of HIV and to understand ways to suppress HIV without long-term antiretroviral treatment.

"Our current strategy to not just treat but cure HIV infection involves both inducing HIV out of its latent state in host T cells and removing or killing infected cells via an immune response or immunotherapy," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "Anktiva is capable of triggering both of these mechanisms, as it can both activate viral transcription in CD4+ T cells—i.e., remove the virus from latency—and activate CD8+ memory cells and natural killer cells that recognize and kill HIV-infected host cells. We look forward to discovering whether or not this activity is correlated with reduction of viral load and inhibition of establishment of the HIV reservoir during acute infection in HIV."

In preliminary data from a separate Phase I study of Anktiva in HIV-infected subjects, the IL-15 superagonist was shown to be safe and to significantly activate proliferation of T cells and natural killer (NK) cells. There was also evidence that Anktiva activated viral transcription and reduced the viral reservoir in peripheral blood mononuclear cells. In addition, in foundational preclinical studies, ImmunityBio observed that Anktiva plus one or two anti-HIV broadly neutralizing antibodies, or bNAbs, suppressed simian/human immunodeficiency virus replication in 9 of 13 animals evaluated. Following these and other preclinical results, the AIDS Clinical Trials Group of the NIH is beginning a Phase I clinical trial (n=46) of Anktiva plus two bNAbs to explore whether the combination affects long-term viral remission.

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