HIV Clinical Trial

Approximately 38 million people worldwide live with HIV, the virus that causes AIDS, making it one of the world’s most serious public health challenges. The virus predominantly affects adults, but approximately five percent of those infected are 15 years old or younger. The vast majority of people with HIV are in low- and middle-income countries; in fact, approximately two of three AIDS patients (25.6 million) are currently living in Africa. In the US, approximately 1.2 million people are living with HIV and nearly 40,000 are newly infected every year, according to HIV.gov.

While significant progress has been made in treating AIDS since its discovery nearly 40 years ago, we still do not have a cure.

Today’s strategy for curing HIV is known as “kick and kill”: “Kick” to activate HIV from its resting state in T cells and “Kill” to clear infected cells via an immune response/immunotherapy. The Anktiva molecule can do both; it induces viral transcription in CD4+ T cells (kick), while strongly activating CD8+ effector memory T cells and NK cells (kill) and directing them to viral reservoirs. Both are important for recognizing and killing HIV-infected cells.

In non-human primate (NHP) experiments, Anktiva activated CD8+ T cells and NK cells and directed them to lymphoid organs, including T cell-protected areas like B-cell follicles, simultaneously reducing the amount of virus present. NHPs infected for 1+ years with simian immunodeficiency virus (SIV) were given Anktiva weekly for four weeks, resulting in a significant reduction of plasma viremia.

Anktiva has also shown strong activation of SIV from latency in NHPs that were also CD8+-depleted, indicating an additional mechanism for shocking HIV from hiding and perturbing the viral reservoir that will be necessary in HIV cure strategies.

In unpublished NHP data, Anktiva and one to two anti-HIV broadly-neutralizing antibodies (bNAbs) allowed long-term suppression of simian/human immunodeficiency virus replication without antiretroviral therapy in 9 of the 13 animals.

ACTG/NIAID: Anktiva plus anti-HIV Broadly Neutralizing Antibodies The purpose of this Phase 1 “HIV Cure Study” is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI). The study (A5386), which will enroll 46 participants, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the AIDS Clinical Trials Group (ACTG), the largest global HIV research network.

Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection The Phase 2, randomized and unblinded study is designed to investigate safety, tolerability and immunostimulatory effects of Anktiva administration during acute HIV infection. Anktiva will be administered subcutaneously at weeks zero, three and six and it will be used along with antiretroviral therapy (ART) to determine whether Anktiva’s immunostimulatory effects reduce HIV titers during the acute stage of 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. The study duration is 12 weeks and will enroll 15 participants. (NCT04505501)

Patrick Soon-Shiong, M.D.,
Founder and Executive Chairman
Forty years after HIV was discovered, it continues to claim more than a million lives worldwide annually. While antiretrovirals have improved patient outcomes and significantly decreased morbidity and mortality, there is neither a vaccine nor a cure for HIV infection. ImmunityBio is therefore searching for a solution that will impact the HIV reservoir. We are studying how a combination therapy with Anktiva, our IL-15 superagonist, which activates NK and CD8+ T cells together with broadly neutralizing antibodies, may stimulate the immune system to enable immune control of HIV in the absence of antiretroviral treatment.

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Our NK-92® cell line provides a versatile bioanalytical testing solution that helps researchers develop functional killing assays that are more consistent and reliable than donor blood and reporter gene assays.

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