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ImmunityBio Announces HIV Clinical Pipeline with Opening of a Phase 1 ‘HIV Cure Study’ in Patients Off Therapy and a Phase 2 Study in Acutely Infected Patients
Sponsored by the NIAID and AIDS Clinical Trials Group, an “HIV cure study” will evaluate whether IL-15 superagonist AnktivaÔ (N-803) alone or together with
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nSponsored by the NIAID and AIDS Clinical Trials Group, an “HIV cure study” will evaluate whether IL-15 superagonist AnktivaÔ (N-803) alone or together with broadly neutralizing antibodies can control HIV following interruption of antiretroviral therapy (ART).\n\n\nThe Phase 1 open-label, randomized study will enroll 46 people living with HIV whose virus has been suppressed by ART for approximately two years, including at least 30 percent cisgender women or transgender men.\n\n\nA second clinical trial studying Anktiva in HIV is being conducted by the U.S. Military HIV Research Program in Thailand. The Phase 2 study is evaluating Anktiva 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.\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced its HIV clinical pipeline with an HIV cure study using Anktiva™ (N-803), which is now enrolling participants in the U.S. The trial will study whether Anktiva can control HIV alone or together with combination broadly neutralizing antibodies (bNABs) after participants stop their antiretroviral therapy (ART) and they are carefully monitored. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the AIDS Clinical Trials Group (ACTG), the largest global HIV research network.\n\nThe second study, which was announced earlier this year and is in Phase 2, will evaluate Anktiva in combination with antiretroviral therapy during acute HIV infection. This study is being conducted by the Walter Reed Army Institute of Research’s U.S. Military HIV Research Program (MHRP) at the Thai Red Cross AIDS Research Centre in Bangkok.\n\nIn both pre-clinical and clinical research, ImmunityBio’s IL-15 superagonist Anktiva has exhibited three activities that could potentially help the immune system to eliminate HIV reservoirs or to control virus rebound. First, Anktiva has been shown to reverse HIV latency—by activating HIV replication within long-lived cells in the immune system thus allowing the infected cells to be recognized and cleared by the immune system. Second, it activates natural killer (NK) cells and CD8+ T-cells, two elements of the i...