ImmunityBio Announces Promising Clinical Study Results for ‘Kick and Kill’ HIV Cure Strategy to Reduce HIV Viral Load with Anktiva (N-803) Therapy
- Data from the Phase 1 “HIV Cure” Study as published in Nature Medicine showed that Anktiva (N-803) stimulates latent HIV replication in CD4+ cells (the kick) and increases immune cell activation (the kill)
- Activated CD4, CD8, and NK immune cells are necessary for finding and killing HIV-infected cells
- No treatment-related serious adverse events were reported
- Multiple Phase 1 and 2 trials with Anktiva in patients with HIV are ongoing
The need for this therapeutic approach is significant: Globally there are an estimated 38 million people living with HIV; in the US, with 1.2 million people living with HIV, the average annual cost of antiretrovirals is
$36,000, while nearly $2 billionis spent on those therapies in developing countries1 & 2
The study was conducted by
“Today there are 38 million people living with HIV in every corner of the world, and most of them depend on a daily cocktail of antiretroviral drugs to keep the virus at bay. These can cost thousands of dollars a month, a huge cost in wealthy countries and unaffordable for people in poorer nations,” said
Study Adds to Existing Results
In both pre-clinical and clinical research, ImmunityBio’s IL-15 superagonist Anktiva has exhibited three activities that could potentially help the immune system eliminate HIV reservoirs and control virus rebound. First, Anktiva has been shown to reverse HIV latency—whereby genetic code for the virus persists, but virus is not made, allowing the infected cells to evade detection and elimination by the immune system—by stimulating HIV replication within long-lived immune cells such as memory CD4 cells, allowing the infected cells to be recognized and cleared. Second, it activates NK cells and CD8+ T cells, two elements of the immune system that specialize in killing virus-infected cells. Third, it enables NK cells and CD8+ T cells to move to lymphoid tissues where they will encounter and have an increased likelihood of eliminating HIV-infected cells.
Study Details (NCT02191098)
ART-suppressed individuals were enrolled into a dose-escalation study of N-803 in four different cohorts (0.3, 1.0, 3.0, and 6.0 mcg/kg). Each cohort received three doses total, separated by at least one week. The study enrolled 16 individuals, of which 11 completed all three doses. The maximum tolerated dose was 6.0 mcg/kg. The primary clinical adverse events (AEs) reported were an injection site rash and adenopathy and four participants experienced a grade 1 or 2 QTc prolongation, which was deemed unrelated to the N-803 administration. There were no significant laboratory AEs attributable to N-803. In exploratory analyses, N-803 was associated with proliferation and/or activation of CD4+ and CD8+ T cells, and NK cells, that peaked at four days post dosing. IFN, IP10, MCP-1, and IL-15 increased during treatment. HIV transcription in memory CD4 T cells and intact proviral DNA initially increased after N-803 treatment and there was a small but significant decrease in the frequency of PBMCs with an inducible HIV provirus that persisted for up to six months post therapy.
Additional HIV-related studies involving N-803
The ACTG A5386 trial is studying 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 “HIV Cure” study is sponsored by the
A second study, which is in Phase 2, will evaluate Anktiva in combination with antiretroviral therapy during acute HIV infection. This study is being conducted by the
ImmunityBio’s clinical pipeline consists of 21 clinical trials—13 of which are in Phase II or III development—across 12 indications in solid and liquid cancers (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV). Anktiva™, ImmunityBio’s lead cytokine infusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the
The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: www.immunitybio.com.
Clinton Health Access Initiative, 2021 HIV Market Report
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the development of therapeutics for HIV, cancer and infectious diseases, clinical trial results, the efficacy of ImmunityBio’s product candidates as compared to existing treatment options, and regulatory approval, commercialization and commercial success of ImmunityBio’s product candidates and related matters. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to
844-696-5235, Option 5