Ibalizumab

    Ibalizumab is an investigational drug that is being studied for the treatment of HIV infection.

    Ibalizumab belongs to a class (group) of HIV drugs called entry and fusion inhibitors. Entry and fusion inhibitors block HIV from getting into and infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.

    Ibalizumab works by attaching to a protein on the surface of the immune cells. The protein is called the CD4 receptor. When ibalizumab attaches to the CD4 receptor, HIV cannot attach to, enter, or infect the cell.

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    [td_text_with_title custom_title=”From Wikipedia”]
    Ibalizumab
    Monoclonal antibody
    Type Whole antibody
    Source Humanized (from mouse)
    Target CD4
    Clinical data
    Trade names Trogarzo
    Synonyms Ibalizumab-uiyk; TMB-355,[1] TNX-355
    Pregnancy
    category
    • unknown; not enough clinical trial data yet
    Routes of
    administration
    intravenous (IV) injection
    ATC code
    • none
    Legal status
    Legal status
    Identifiers
    CAS Number
    ChemSpider
    • none
    UNII
    KEGG
    NIAID ChemDB
     NoYesY (what is this?)  (verify)

    Ibalizumab (trade name Trogarzo) is a non-immunosuppressive monoclonal antibody that binds CD4, the primary receptor for HIV, and inhibits the viral entry process.[2] It is being investigated as an HIV entry inhibitor[3] with the ability to block both CCR5- and CXCR4-tropic viruses,[4] and is undergoing a Phase II clinical trial with an estimated study completion date in December 2010.[5] Specific research is also conducted at the Aaron Diamond AIDS Research Center under the direction of David Ho.[6][7]

    Results from a previous Phase II of ibalizumab, reported by the original developer Tanox in 2006,[4] showed that persons with HIV who received the drug, in combination with an optimized background regimen (OBR), maintained a considerably greater reduction in viral load and experienced a statistically significant increase in CD4+ cells than did patients given placebo in combination with OBR. Thus, pending results of further trials, it is one of a limited number of viable alternative strategies to contain the virus without recourse to antiretroviral drug cocktails or a vaccine.

    On March 6, 2018, FDA approved ibalizumab for multidrug-resistant HIV-1.[8] It's administered intravenously every 14 days by a trained medical professional. It is used in combination with other antiretroviral drugs.[9]

    Development

    Ibalizumab is being developed by TaiMed Biologics but was first developed by Tanox, now part of Genentech. As part of Genentech's takeover of Tanox, the patent for ibalizumab was sold to TaiMed Biologics, a biotech company formed in 2007 with support from the Taiwanese Government through a $20 million investment by the state-owned National Development Fund.[10][11][12]

    Milestones for the intravenous (i.v.) infusion dosage form:[13]

    • 2003: completed a phase-1a clinical trial for i.v. infusion dosage form.
    • 2003: granted fast track status by U.S. FDA.
    • 2003: completed a phase-1b clinical trial for i.v. infusion dosage form.
    • 2006: completed a phase-2a clinical trial for i.v. infusion dosage form.
    • 2011: completed a phase-2b clinical trial for i.v. infusion dosage form.
    • 2012: completed a phase-1 clinical trial for s.c. injection dosage form.
    • 2013: initiated a phase-1/2 clinical trial for s.c. and i.m. injection dosage forms (on-going).
    • 2014: granted orphan drug designation for HIV MDR patients by U.S. FDA.
    • 2015: granted breakthrough therapy designation for i.v. infusion dosage form by U.S. FDA.
    • 2015: initiated a phase-3 clinical trial for i.v. infusion dosage form (on-going).
    • 2016: initiated and intended to complete a rolling BLA submission for i.v. infusion dosage form to U.S. FDA.
    • 2016: completion of a phase-3 clinical trial for i.v. infusion dosage form
    • 2017: completion of BLA submission and pre-approval inspection for i.v. infusion dosage form to U.S. FDA
    • 2018: U.S. market approval (trade name: Trogarzo)

    References

    1. ^ "Ibalizumab (TMB-355)". TaiMed Biologics. 2009-09-09. Archived from the original on 2009-08-20. 
    2. ^ Jacobson JM, Kuritzkes DR, Godofsky E, et al. (February 2009). "Safety, Pharmacokinetics, and Antiretroviral Activity of Multiple Doses of Ibalizumab (formerly TNX-355), an Anti-CD4 Monoclonal Antibody, in Human Immunodeficiency Virus Type 1-Infected Adults". Antimicrob. Agents Chemother. 53 (2): 450–7. doi:10.1128/AAC.00942-08. PMC 2630626Freely accessible. PMID 19015347. 
    3. ^ "TNX-355 fact sheet". AIDSmeds.com. 2006-08-25. 
    4. ^ a b "Tanox Reports 48-Week Results From TNX-355 Phase 2 Clinical Trial". AEGiS. 2006-05-02. 
    5. ^ "Dose-Response Study of Ibalizumab + OBR in Patients With HIV-1". ClinicalTrials.gov. 2008-10-30. 
    6. ^ Park, Alice (2010-01-25). "David Ho: The Man Who Could Beat AIDS". Time. Retrieved 2010-05-04. 
    7. ^ "Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers (TMB-108)". ClinicalTrials.gov. 2011-02-07. 
    8. ^ "Ibalizumab". 2018-03-07. 
    9. ^ "FDA Approves Ibalizumab for Multidrug-Resistant HIV-1". 2018-03-07. 
    10. ^ "Genentech Partners with Taiwan Company on AIDS Drug". Seeking Alpha. 2007-09-18. 
    11. ^ "Government pushes biotech industry". Taipei Times. 2007-09-15. 
    12. ^ "Tanox's AIDS Drug Survives". BioHouston. 2008-04-11. Archived from the original on 2011-07-25. 
    13. ^ "Ibalizumab (TMB-355) Intravenous Infusion". www.taimedbiologics.com. TaiMed. Retrieved 17 March 2018. 
    source: https://en.wikipedia.org/wiki/Ibalizumab[/td_text_with_title]